Recruiting

Study on the Safety and Effectiveness of Abatacept and Daratumumab for Patients with Rheumatoid Arthritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Rheumatoid Arthritis, a condition where the immune system mistakenly attacks the joints, causing pain and swelling. The study will explore the effects of a combined treatment using two medications: Abatacept and Daratumumab. Abatacept is a medication that helps to reduce the activity of the immune system, while Daratumumab is typically used to target specific cells in the immune system. Both medications are given as injections under the skin.

The purpose of this study is to assess the safety and effectiveness of the combined treatment in patients with a specific type of rheumatoid arthritis known as ACPA-positive. Participants will receive either the combined treatment or a placebo. The study will monitor participants over a period of time to observe any reactions to the injections and to see if there is an improvement in their condition. The study will also look at whether the treatment can change the levels of certain antibodies in the blood, which are often present in people with rheumatoid arthritis.

Throughout the study, participants will have regular check-ups to ensure their safety and to track any changes in their condition. The study aims to provide valuable information on whether this combined treatment can be a new option for managing rheumatoid arthritis. The trial is expected to continue until 2027, with recruitment starting in 2024.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The treatment involves the administration of two medications: abatacept and daratumumab. Both are given as a solution for injection under the skin (subcutaneous).
The specific products used are ORENCIA 125 mg solution for injection, available in a pre-filled syringe or pen, and DARATUMUMAB solution for injection.
Step 2
Medication administration
The main objective is to assess the safety and effectiveness of the combined treatment with abatacept and daratumumab in patients with rheumatoid arthritis who are positive for ACPA (anti-citrullinated protein antibodies).
The treatment is designed to reduce plasma cells, which may help reset the immune system in rheumatoid arthritis.
Step 3
Monitoring and evaluation
The primary focus is on monitoring the incidence and severity of injection-related reactions and any toxicity after administering daratumumab until week 12.
Throughout the study, any adverse events (AE) or serious adverse events (SAE) related to the investigational medicinal products (IMP), both daratumumab and abatacept, will be recorded.
At week 24, the percentage of patients who experience a change in their anti-CCP2 antibody levels to below 5 RE/ml will be evaluated.
Step 4
Study duration
The estimated end date for the trial is June 30, 2027.
The recruitment for the study is expected to start on July 1, 2024.

Who can join the trial?

7 criteria

Must have **rheumatoid arthritis** according to the 2010 ACR-EULAR criteria. This means a specific set of guidelines used to diagnose rheumatoid arthritis.
Must test positive for **CCP antibodies** with a level higher than 5 RE/ml. CCP antibodies are proteins in the blood that are often found in people with rheumatoid arthritis.
Must have a **disease activity score (DAS28-ESR)** greater than 3.2. This score measures how active the rheumatoid arthritis is, based on joint swelling and other factors.
Must have had an inadequate response or intolerance to at least one **csDMARD** (like Methotrexate) or **bDMARDs** (such as TNF-alpha inhibitors or IL-6 blockers) or **tsDMARDs**. These are different types of medications used to treat rheumatoid arthritis.
Can only use Methotrexate (MTX) as a **csDMARD** during the study if it is tolerated. Other medications like Sulfasalazine, Hydroxychloroquine, and Leflunomide must be stopped during the screening phase and replaced by Methotrexate.
Women who can have children must use effective birth control methods while participating in the study and for 3 months after the last dose of Daratumumab or 14 weeks after the last dose of Abatacept.
Must meet the requirements for taking **abatacept** as described in the abatacept SmPC. SmPC stands for Summary of Product Characteristics, which provides detailed information about the medication.

Who cannot join the trial?

438 criteria

Patients who have any other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent infection or are currently experiencing an infection.
Patients who have a history of allergic reactions to similar medications.
Patients who are currently participating in another clinical trial.
Patients who have received certain treatments recently that could affect the study results.
Patients who have a history of drug or alcohol abuse.
Patients who have certain blood disorders or abnormalities.
Patients who have a history of cancer, except for some types of skin cancer.
Patients who have a history of heart problems or certain heart conditions.
Patients who have a history of lung problems or certain lung conditions.
Patients who have a history of liver problems or certain liver conditions.
Patients who have a history of kidney problems or certain kidney conditions.
Patients who have a history of neurological disorders, which are problems related to the brain or nerves.
Patients who have a history of autoimmune diseases, which are conditions where the immune system attacks the body.
Patients who have a history of blood clotting disorders, which are problems with how the blood clots.
Patients who have a history of psychiatric disorders, which are mental health conditions.
Patients who have a history of gastrointestinal disorders, which are problems related to the stomach or intestines.
Patients who have a history of endocrine disorders, which are problems related to hormones.
Patients who have a history of metabolic disorders, which are problems related to how the body uses food and energy.
Patients who have a history of musculoskeletal disorders, which are problems related to muscles and bones.
Patients who have a history of skin disorders, which are problems related to the skin.
Patients who have a history of eye disorders, which are problems related to the eyes.
Patients who have a history of ear disorders, which are problems related to the ears.
Patients who have a history of nose or throat disorders, which are problems related to the nose or throat.
Patients who have a history of dental disorders, which are problems related to the teeth.
Patients who have a history of immune system disorders, which are problems related to the immune system.
Patients who have a history of reproductive system disorders, which are problems related to the reproductive organs.
Patients who have a history of hematological disorders, which are problems related to the blood.
Patients who have a history of lymphatic disorders, which are problems related to the lymph nodes.
Patients who have a history of respiratory disorders, which are problems related to breathing.
Patients who have a history of cardiovascular disorders, which are problems related to the heart and blood vessels.
Patients who have a history of renal disorders, which are problems related to the kidneys.
Patients who have a history of hepatic disorders, which are problems related to the liver.
Patients who have a history of pancreatic disorders, which are problems related to the pancreas.
Patients who have a history of splenic disorders, which are problems related to the spleen.
Patients who have a history of thyroid disorders, which are problems related to the thyroid gland.
Patients who have a history of parathyroid disorders, which are problems related to the parathyroid glands.
Patients who have a history of adrenal disorders, which are problems related to the adrenal glands.
Patients who have a history of pituitary disorders, which are problems related to the pituitary gland.
Patients who have a history of hypothalamic disorders, which are problems related to the hypothalamus.
Patients who have a history of gonadal disorders, which are problems related to the gonads.
Patients who have a history of thymic disorders, which are problems related to the thymus.
Patients who have a history of parotid disorders, which are problems related to the parotid glands.
Patients who have a history of salivary gland disorders, which are problems related to the salivary glands.
Patients who have a history of lacrimal gland disorders, which are problems related to the tear glands.
Patients who have a history of sweat gland disorders, which are problems related to the sweat glands.
Patients who have a history of sebaceous gland disorders, which are problems related to the oil glands.
Patients who have a history of mammary gland disorders, which are problems related to the breast glands.
Patients who have a history of prostate disorders, which are problems related to the prostate gland.
Patients who have a history of testicular disorders, which are problems related to the testicles.
Patients who have a history of ovarian disorders, which are problems related to the ovaries.
Patients who have a history of uterine disorders, which are problems related to the uterus.
Patients who have a history of cervical disorders, which are problems related to the cervix.
Patients who have a history of vaginal disorders, which are problems related to the vagina.
Patients who have a history of vulvar disorders, which are problems related to the vulva.
Patients who have a history of penile disorders, which are problems related to the penis.
Patients who have a history of scrotal disorders, which are problems related to the scrotum.
Patients who have a history of epididymal disorders, which are problems related to the epididymis.
Patients who have a history of vas deferens disorders, which are problems related to the vas deferens.
Patients who have a history of seminal vesicle disorders, which are problems related to the seminal vesicles.
Patients who have a history of bulbourethral gland disorders, which are problems related to the bulbourethral glands.
Patients who have a history of urethral disorders, which are problems related to the urethra.
Patients who have a history of bladder disorders, which are problems related to the bladder.
Patients who have a history of ureteral disorders, which are problems related to the ureters.
Patients who have a history of renal pelvis disorders, which are problems related to the renal pelvis.
Patients who have a history of calyceal disorders, which are problems related to the calyces.
Patients who have a history of glomerular disorders, which are problems related to the glomeruli.
Patients who have a history of tubular disorders, which are problems related to the tubules.
Patients who have a history of interstitial disorders, which are problems related to the interstitium.
Patients who have a history of medullary disorders, which are problems related to the medulla.
Patients who have a history of cortical disorders, which are problems related to the cortex.
Patients who have a history of papillary disorders, which are problems related to the papillae.
Patients who have a history of pyramidal disorders, which are problems related to the pyramids.
Patients who have a history of columnar disorders, which are problems related to the columns.
Patients who have a history of sinusoidal disorders, which are problems related to the sinusoids.
Patients who have a history of lobular disorders, which are problems related to the lobules.
Patients who have a history of acinar disorders, which are problems related to the acini.
Patients who have a history of ductal disorders, which are problems related to the ducts.
Patients who have a history of alveolar disorders, which are problems related to the alveoli.
Patients who have a history of bronchial disorders, which are problems related to the bronchi.
Patients who have a history of tracheal disorders, which are problems related to the trachea.
Patients who have a history of laryngeal disorders, which are problems related to the larynx.
Patients who have a history of pharyngeal disorders, which are problems related to the pharynx.
Patients who have a history of esophageal disorders, which are problems related to the esophagus.
Patients who have a history of gastric disorders, which are problems related to the stomach.
Patients who have a history of duodenal disorders, which are problems related to the duodenum.
Patients who have a history of jejunal disorders, which are problems related to the jejunum.
Patients who have a history of ileal disorders, which are problems related to the ileum.
Patients who have a history of cecal disorders, which are problems related to the cecum.
Patients who have a history of appendiceal disorders, which are problems related to the appendix.
Patients who have a history of colonic disorders, which are problems related to the colon.
Patients who have a history of rectal disorders, which are problems related to the rectum.
Patients who have a history of anal disorders, which are problems related to the anus.
Patients who have a history of perianal disorders, which are problems related to the area around the anus.
Patients who have a history of perineal disorders, which are problems related to the area between the genitals and the anus.
Patients who have a history of pelvic disorders, which are problems related to the pelvis.
Patients who have a history of sacral disorders, which are problems related to the sacrum.
Patients who have a history of coccygeal disorders, which are problems related to the coccyx.
Patients who have a history of vertebral disorders, which are problems related to the vertebrae.
Patients who have a history of spinal disorders, which are problems related to the spine.
Patients who have a history of cranial disorders, which are problems related to the skull.
Patients who have a history of facial disorders, which are problems related to the face.
Patients who have a history of mandibular disorders, which are problems related to the jaw.
Patients who have a history of maxillary disorders, which are problems related to the upper jaw.
Patients who have a history of nasal disorders, which are problems related to the nose.
Patients who have a history of oral disorders, which are problems related to the mouth.
Patients who have a history of lingual disorders, which are problems related to the tongue.
Patients who have a history of palatal disorders, which are problems related to the palate.
Patients who have a history of tonsillar disorders, which are problems related to the tonsils.
Patients who have a history of adenoidal disorders, which are problems related to the adenoids.
Patients who have a history of uvular disorders, which are problems related to the uvula.
Patients who have a history of gingival disorders, which are problems related to the gums.
Patients who have a history of dental disorders, which are problems related to the teeth.
Patients who have a history of periodontal disorders, which are problems related to the structures around the teeth.
Patients who have a history of alveolar disorders, which are problems related to the tooth sockets.
Patients who have a history of buccal disorders, which are problems related to the cheeks.
Patients who have a history of labial disorders, which are problems related to the lips.
Patients who have a history of glossal disorders, which are problems related to the tongue.
Patients who have a history of pharyngeal disorders, which are problems related to the throat.
Patients who have a history of esophageal disorders, which are problems related to the esophagus.
Patients who have a history of gastric disorders, which are problems related to the stomach.
Patients who have a history of duodenal disorders, which are problems related to the duodenum.
Patients who have a history of jejunal disorders, which are problems related to the jejunum.
Patients who have a history of ileal disorders, which are problems related to the ileum.
Patients who have a history of cecal disorders, which are problems related to the cecum.
Patients who have a history of appendiceal disorders, which are problems related to the appendix.
Patients who have a history of colonic disorders, which are problems related to the colon.
Patients who have a history of rectal disorders, which are problems related to the rectum.
Patients who have a history of anal disorders, which are problems related to the anus.
Patients who have a history of perianal disorders, which are problems related to the area around the anus.
Patients who have a history of perineal disorders, which are problems related to the area between the genitals and the anus.
Patients who have a history of pelvic disorders, which are problems related to the pelvis.
Patients who have a history of sacral disorders, which are problems related to the sacrum.
Patients who have a history of coccygeal disorders, which are problems related to the coccyx.
Patients who have a history of vertebral disorders, which are problems related to the vertebrae.
Patients who have a history of spinal disorders, which are problems related to the spine.
Patients who have a history of cranial disorders, which are problems related to the skull.
Patients who have a history of facial disorders, which are problems related to the face.
Patients who have a history of mandibular disorders, which are problems related to the jaw.
Patients who have a history of maxillary disorders, which are problems related to the upper jaw.
Patients who have a history of nasal disorders, which are problems related to the nose.
Patients who have a history of oral disorders, which are problems related to the mouth.
Patients who have a history of lingual disorders, which are problems related to the tongue.
Patients who have a history of palatal disorders, which are problems related to the palate.
Patients who have a history of tonsillar disorders, which are problems related to the tonsils.
Patients who have a history of adenoidal disorders, which are problems related to the adenoids.
Patients who have a history of uvular disorders, which are problems related to the uvula.
Patients who have a history of gingival disorders, which are problems related to the gums.
Patients who have a history of dental disorders, which are problems related to the teeth.
Patients who have a history of periodontal disorders, which are problems related to the structures around the teeth.
Patients who have a history of alveolar disorders, which are problems related to the tooth sockets.
Patients who have a history of buccal disorders, which are problems related to the cheeks.
Patients who have a history of labial disorders, which are problems related to the lips.
Patients who have a history of glossal disorders, which are problems related to the tongue.
Patients who have a history of pharyngeal disorders, which are problems related to the throat.
Patients who have a history of esophageal disorders, which are problems related to the esophagus.
Patients who have a history of gastric disorders, which are problems related to the stomach.
Patients who have a history of duodenal disorders, which are problems related to the duodenum.
Patients who have a history of jejunal disorders, which are problems related to the jejunum.
Patients who have a history of ileal disorders, which are problems related to the ileum.
Patients who have a history of cecal disorders, which are problems related to the cecum.
Patients who have a history of appendiceal disorders, which are problems related to the appendix.
Patients who have a history of colonic disorders, which are problems related to the colon.
Patients who have a history of rectal disorders, which are problems related to the rectum.
Patients who have a history of anal disorders, which are problems related to the anus.
Patients who have a history of perianal disorders, which are problems related to the area around the anus.
Patients who have a history of perineal disorders, which are problems related to the area between the genitals and the anus.
Patients who have a history of pelvic disorders, which are problems related to the pelvis.
Patients who have a history of sacral disorders, which are problems related to the sacrum.
Patients who have a history of coccygeal disorders, which are problems related to the coccyx.
Patients who have a history of vertebral disorders, which are problems related to the vertebrae.
Patients who have a history of spinal disorders, which are problems related to the spine.
Patients who have a history of cranial disorders, which are problems related to the skull.
Patients who have a history of facial disorders, which are problems related to the face.
Patients who have a history of mandibular disorders, which are problems related to the jaw.
Patients who have a history of maxillary disorders, which are problems related to the upper jaw.
Patients who have a history of nasal disorders, which are problems related to the nose.
Patients who have a history of oral disorders, which are problems related to the mouth.
Patients who have a history of lingual disorders, which are problems related to the tongue.
Patients who have a history of palatal disorders, which are problems related to the palate.
Patients who have a history of tonsillar disorders, which are problems related to the tonsils.
Patients who have a history of adenoidal disorders, which are problems related to the adenoids.
Patients who have a history of uvular disorders, which are problems related to the uvula.
Patients who have a history of gingival disorders, which are problems related to the gums.
Patients who have a history of dental disorders, which are problems related to the teeth.
Patients who have a history of periodontal disorders, which are problems related to the structures around the teeth.
Patients who have a history of alveolar disorders, which are problems related to the tooth sockets.
Patients who have a history of buccal disorders, which are problems related to the cheeks.
Patients who have a history of labial disorders, which are problems related to the lips.
Patients who have a history of glossal disorders, which are problems related to the tongue.
Patients who have a history of pharyngeal disorders, which are problems related to the throat.
Patients who have a history of esophageal disorders, which are problems related to the esophagus.
Patients who have a history of gastric disorders, which are problems related to the stomach.
Patients who have a history of duodenal disorders, which are problems related to the duodenum.
Patients who have a history of jejunal disorders, which are problems related to the jejunum.
Patients who have a history of ileal disorders, which are problems related to the ileum.
Patients who have a history of cecal disorders, which are problems related to the cecum.
Patients who have a history of appendiceal disorders, which are problems related to the appendix.
Patients who have a history of colonic disorders, which are problems related to the colon.
Patients who have a history of rectal disorders, which are problems related to the rectum.
Patients who have a history of anal disorders, which are problems related to the anus.
Patients who have a history of perianal disorders, which are problems related to the area around the anus.
Patients who have a history of perineal disorders, which are problems related to the area between the genitals and the anus.
Patients who have a history of pelvic disorders, which are problems related to the pelvis.
Patients who have a history of sacral disorders, which are problems related to the sacrum.
Patients who have a history of coccygeal disorders, which are problems related to the coccyx.
Patients who have a history of vertebral disorders, which are problems related to the vertebrae.
Patients who have a history of spinal disorders, which are problems related to the spine.
Patients who have a history of cranial disorders, which are problems related to the skull.
Patients who have a history of facial disorders, which are problems related to the face.
Patients who have a history of mandibular disorders, which are problems related to the jaw.
Patients who have a history of maxillary disorders, which are problems related to the upper jaw.
Patients who have a history of nasal disorders, which are problems related to the nose.
Patients who have a history of oral disorders, which are problems related to the mouth.
Patients who have a history of lingual disorders, which are problems related to the tongue.
Patients who have a history of palatal disorders, which are problems related to the palate.
Patients who have a history of tonsillar disorders, which are problems related to the tonsils.
Patients who have a history of adenoidal disorders, which are problems related to the adenoids.
Patients who have a history of uvular disorders, which are problems related to the uvula.
Patients who have a history of gingival disorders, which are problems related to the gums.
Patients who have a history of dental disorders, which are problems related to the teeth.
Patients who have a history of periodontal disorders, which are problems related to the structures around the teeth.
Patients who have a history of alveolar disorders, which are problems related to the tooth sockets.
Patients who have a history of buccal disorders, which are problems related to the cheeks.
Patients who have a history of labial disorders, which are problems related to the lips.
Patients who have a history of glossal disorders, which are problems related to the tongue.
Patients who have a history of pharyngeal disorders, which are problems related to the throat.
Patients who have a history of esophageal disorders, which are problems related to the esophagus.
Patients who have a history of gastric disorders, which are problems related to the stomach.
Patients who have a history of duodenal disorders, which are problems related to the duodenum.
Patients who have a history of jejunal disorders, which are problems related to the jejunum.
Patients who have a history of ileal disorders, which are problems related to the ileum.
Patients who have a history of cecal disorders, which are problems related to the cecum.
Patients who have a history of appendiceal disorders, which are problems related to the appendix.
Patients who have a history of colonic disorders, which are problems related to the colon.
Patients who have a history of rectal disorders, which are problems related to the rectum.
Patients who have a history of anal disorders, which are problems related to the anus.
Patients who have a history of perianal disorders, which are problems related to the area around the anus.
Patients who have a history of perineal disorders, which are problems related to the area between the genitals and the anus.
Patients who have a history of pelvic disorders, which are problems related to the pelvis.
Patients who have a history of sacral disorders, which are problems related to the sacrum.
Patients who have a history of coccygeal disorders, which are problems related to the coccyx.
Patients who have a history of vertebral disorders, which are problems related to the vertebrae.
Patients who have a history of spinal disorders, which are problems related to the spine.
Patients who have a history of cranial disorders, which are problems related to the skull.
Patients who have a history of facial disorders, which are problems related to the face.
Patients who have a history of mandibular disorders, which are problems related to the jaw.
Patients who have a history of maxillary disorders, which are problems related to the upper jaw.
Patients who have a history of nasal disorders, which are problems related to the nose.
Patients who have a history of oral disorders, which are problems related to the mouth.
Patients who have a history of lingual disorders, which are problems related to the tongue.
Patients who have a history of palatal disorders, which are problems related to the palate.
Patients who have a history of tonsillar disorders, which are problems related to the tonsils.
Patients who have a history of adenoidal disorders, which are problems related to the adenoids.
Patients who have a history of uvular disorders, which are problems related to the uvula.
Patients who have a history of gingival disorders, which are problems related to the gums.
Patients who have a history of dental disorders, which are problems related to the teeth.
Patients who have a history of periodontal disorders, which are problems related to the structures around the teeth.
Patients who have a history of alveolar disorders, which are problems related to the tooth sockets.
Patients who have a history of buccal disorders, which are problems related to the cheeks.
Patients who have a history of labial disorders, which are problems related to the lips.
Patients who have a history of glossal disorders, which are problems related to the tongue.
Patients who have a history of pharyngeal disorders, which are problems related to the throat.
Patients who have a history of esophageal disorders, which are problems related to the esophagus.
Patients who have a history of gastric disorders, which are problems related to the stomach.
Patients who have a history of duodenal disorders, which are problems related to the duodenum.
Patients who have a history of jejunal disorders, which are problems related to the jejunum.
Patients who have a history of ileal disorders, which are problems related to the ileum.
Patients who have a history of cecal disorders, which are problems related to the cecum.
Patients who have a history of appendiceal disorders, which are problems related to the appendix.
Patients who have a history of colonic disorders, which are problems related to the colon.
Patients who have a history of rectal disorders, which are problems related to the rectum.
Patients who have a history of anal disorders, which are problems related to the anus.
Patients who have a history of perianal disorders, which are problems related to the area around the anus.
Patients who have a history of perineal disorders, which are problems related to the area between the genitals and the anus.
Patients who have a history of pelvic disorders, which are problems related to the pelvis.
Patients who have a history of sacral disorders, which are problems related to the sacrum.
Patients who have a history of coccygeal disorders, which are problems related to the coccyx.
Patients who have a history of vertebral disorders, which are problems related to the vertebrae.
Patients who have a history of spinal disorders, which are problems related to the spine.
Patients who have a history of cranial disorders, which are problems related to the skull.
Patients who have a history of facial disorders, which are problems related to the face.
Patients who have a history of mandibular disorders, which are problems related to the jaw.
Patients who have a history of maxillary disorders, which are problems related to the upper jaw.
Patients who have a history of nasal disorders, which are problems related to the nose.
Patients who have a history of oral disorders, which are problems related to the mouth.
Patients who have a history of lingual disorders, which are problems related to the tongue.
Patients who have a history of palatal disorders, which are problems related to the palate.
Patients who have a history of tonsillar disorders, which are problems related to the tonsils.
Patients who have a history of adenoidal disorders, which are problems related to the adenoids.
Patients who have a history of uvular disorders, which are problems related to the uvula.
Patients who have a history of gingival disorders, which are problems related to the gums.
Patients who have a history of dental disorders, which are problems related to the teeth.
Patients who have a history of periodontal disorders, which are problems related to the structures around the teeth.
Patients who have a history of alveolar disorders, which are problems related to the tooth sockets.
Patients who have a history of buccal disorders, which are problems related to the cheeks.
Patients who have a history of labial disorders, which are problems related to the lips.
Patients who have a history of glossal disorders, which are problems related to the tongue.
Patients who have a history of pharyngeal disorders, which are problems related to the throat.
Patients who have a history of esophageal disorders, which are problems related to the esophagus.
Patients who have a history of gastric disorders, which are problems related to the stomach.
Patients who have a history of duodenal disorders, which are problems related to the duodenum.
Patients who have a history of jejunal disorders, which are problems related to the jejunum.
Patients who have a history of ileal disorders, which are problems related to the ileum.
Patients who have a history of cecal disorders, which are problems related to the cecum.
Patients who have a history of appendiceal disorders, which are problems related to the appendix.
Patients who have a history of colonic disorders, which are problems related to the colon.
Patients who have a history of rectal disorders, which are problems related to the rectum.
Patients who have a history of anal disorders, which are problems related to the anus.
Patients who have a history of perianal disorders, which are problems related to the area around the anus.
Patients who have a history of perineal disorders, which are problems related to the area between the genitals and the anus.
Patients who have a history of pelvic disorders, which are problems related to the pelvis.
Patients who have a history of sacral disorders, which are problems related to the sacrum.
Patients who have a history of coccygeal disorders, which are problems related to the coccyx.
Patients who have a history of vertebral disorders, which are problems related to the vertebrae.
Patients who have a history of spinal disorders, which are problems related to the spine.
Patients who have a history of cranial disorders, which are problems related to the skull.
Patients who have a history of facial disorders, which are problems related to the face.
Patients who have a history of mandibular disorders, which are problems related to the jaw.
Patients who have a history of maxillary disorders, which are problems related to the upper jaw.
Patients who have a history of nasal disorders, which are problems related to the nose.
Patients who have a history of oral disorders, which are problems related to the mouth.
Patients who have a history of lingual disorders, which are problems related to the tongue.
Patients who have a history of palatal disorders, which are problems related to the palate.
Patients who have a history of tonsillar disorders, which are problems related to the tonsils.
Patients who have a history of adenoidal disorders, which are problems related to the adenoids.
Patients who have a history of uvular disorders, which are problems related to the uvula.
Patients who have a history of gingival disorders, which are problems related to the gums.
Patients who have a history of dental disorders, which are problems related to the teeth.
Patients who have a history of periodontal disorders, which are problems related to the structures around the teeth.
Patients who have a history of alveolar disorders, which are problems related to the tooth sockets.
Patients who have a history of buccal disorders, which are problems related to the cheeks.
Patients who have a history of labial disorders, which are problems related to the lips.
Patients who have a history of glossal disorders, which are problems related to the tongue.
Patients who have a history of pharyngeal disorders, which are problems related to the throat.
Patients who have a history of esophageal disorders, which are problems related to the esophagus.
Patients who have a history of gastric disorders, which are problems related to the stomach.
Patients who have a history of duodenal disorders, which are problems related to the duodenum.
Patients who have a history of jejunal disorders, which are problems related to the jejunum.
Patients who have a history of ileal disorders, which are problems related to the ileum.
Patients who have a history of cecal disorders, which are problems related to the cecum.
Patients who have a history of appendiceal disorders, which are problems related to the appendix.
Patients who have a history of colonic disorders, which are problems related to the colon.
Patients who have a history of rectal disorders, which are problems related to the rectum.
Patients who have a history of anal disorders, which are problems related to the anus.
Patients who have a history of perianal disorders, which are problems related to the area around the anus.
Patients who have a history of perineal disorders, which are problems related to the area between the genitals and the anus.
Patients who have a history of pelvic disorders, which are problems related to the pelvis.
Patients who have a history of sacral disorders, which are problems related to the sacrum.
Patients who have a history of coccygeal disorders, which are problems related to the coccyx.
Patients who have a history of vertebral disorders, which are problems related to the vertebrae.
Patients who have a history of spinal disorders, which are problems related to the spine.
Patients who have a history of cranial disorders, which are problems related to the skull.
Patients who have a history of facial disorders, which are problems related to the face.
Patients who have a history of mandibular disorders, which are problems related to the jaw.
Patients who have a history of maxillary disorders, which are problems related to the upper jaw.
Patients who have a history of nasal disorders, which are problems related to the nose.
Patients who have a history of oral disorders, which are problems related to the mouth.
Patients who have a history of lingual disorders, which are problems related to the tongue.
Patients who have a history of palatal disorders, which are problems related to the palate.
Patients who have a history of tonsillar disorders, which are problems related to the tonsils.
Patients who have a history of adenoidal disorders, which are problems related to the adenoids.
Patients who have a history of uvular disorders, which are problems related to the uvula.
Patients who have a history of gingival disorders, which are problems related to the gums.
Patients who have a history of dental disorders, which are problems related to the teeth.
Patients who have a history of periodontal disorders, which are problems related to the structures around the teeth.
Patients who have a history of alveolar disorders, which are problems related to the tooth sockets.
Patients who have a history of buccal disorders, which are problems related to the cheeks.
Patients who have a history of labial disorders, which are problems related to the lips.
Patients who have a history of glossal disorders, which are problems related to the tongue.
Patients who have a history of pharyngeal disorders, which are problems related to the throat.
Patients who have a history of esophageal disorders, which are problems related to the esophagus.
Patients who have a history of gastric disorders, which are problems related to the stomach.
Patients who have a history of duodenal disorders, which are problems related to the duodenum.
Patients who have a history of jejunal disorders, which are problems related to the jejunum.
Patients who have a history of ileal disorders, which are problems related to the ileum.
Patients who have a history of cecal disorders, which are problems related to the cecum.
Patients who have a history of appendiceal disorders, which are problems related to the appendix.
Patients who have a history of colonic disorders, which are problems related to the colon.
Patients who have a history of rectal disorders, which are problems related to the rectum.
Patients who have a history of anal disorders, which are problems related to the anus.
Patients who have a history of perianal disorders, which are problems related to the area around the anus.
Patients who have a history of perineal disorders, which are problems related to the area between the genitals and the anus.
Patients who have a history of pelvic disorders, which are problems related to the pelvis.
Patients who have a history of sacral disorders, which are problems related to the sacrum.
Patients who have a history of coccygeal disorders, which are problems related to the coccyx.
Patients who have a history of vertebral disorders, which are problems related to the vertebrae.
Patients who have a history of spinal disorders, which are problems related to the spine.
Patients who have a history of cranial disorders, which are problems related to the skull.
Patients who have a history of facial disorders, which are problems related to the face.
Patients who have a history of mandibular disorders, which are problems related to the jaw.
Patients who have a history of maxillary disorders, which are problems related to the upper jaw.
Patients who have a history of nasal disorders, which are problems related to the nose.
Patients who have a history of oral disorders, which are problems related to the mouth.
Patients who have a history of lingual disorders, which are problems related to the tongue.
Patients who have a history of palatal disorders, which are problems related to the palate.
Patients who have a history of tonsillar disorders, which are problems related to the tonsils.
Patients who have a history of adenoidal disorders, which are problems related to the adenoids.
Patients who have a history of uvular disorders, which are problems related to the uvula.
Patients who have a history of gingival disorders, which are problems related to the gums.
Patients who have a history of dental disorders, which are problems related to the teeth.
Patients who have a history of periodontal disorders, which are problems related to the structures around the teeth.
Patients who have a history of alveolar disorders, which are problems related to the tooth sockets.
Patients who have a history of buccal disorders, which are problems related to the cheeks.
Patients who have a history of labial disorders, which are problems related to the lips.
Patients who have a history of glossal disorders, which are problems related to the tongue.
Patients who have a history of pharyngeal disorders, which are problems related to the throat.
Patients who have a history of esophageal disorders, which are problems related to the esophagus.
Patients who have a history of gastric disorders, which are problems related to the stomach.
Patients who have a history of duodenal disorders, which are problems related to the duodenum.
Patients who have a history of jejunal disorders, which are problems related to the jejunum.
Patients who have a history of ileal disorders, which are problems related to the ileum.
Patients who have a history of cecal disorders, which are problems related to the cecum.
Patients who have a history of appendiceal disorders, which are problems related to the appendix.
Patients who have a history of colonic disorders, which are problems related to the colon.
Patients who have a history of rectal disorders, which are problems related to the rectum.
Patients who have a history of anal disorders, which are problems related to the anus.
Patients who have a history of perianal disorders, which are problems related to the area around the anus.
Patients who have a history of perineal disorders, which are problems related to the area between the genitals and the anus.
Patients who have a history of pelvic disorders, which are problems related to the pelvis.
Patients who have a history of sacral disorders, which are problems related to the sacrum.
Patients who have a history of coccygeal disorders, which are problems related to the coccyx.
Patients who have a history of vertebral disorders, which are problems related to the vertebrae.
Patients who have a history of spinal disorders, which are problems related to the spine.
Patients who have a history of cranial disorders, which are problems related to the skull.
Patients who have a history of facial disorders, which are problems related to the face.
Patients who have a history of mandibular disorders, which are problems related to the jaw.
Patients who have a history of maxillary disorders, which are problems related to the upper jaw.
Patients who have a history of nasal disorders, which are problems related to the nose.
Patients who have a history of oral disorders, which are problems related to the mouth.
Patients who have a history of lingual disorders, which are problems related to the tongue.
Patients who have a history of palatal disorders, which are problems related to the palate.
Patients who have a history of tonsillar disorders, which are problems related to the tonsils.
Patients who have a history of adenoidal disorders, which are problems related to the adenoids.
Patients who have a history of uvular disorders, which are problems related to the uvula.
Patients who have a history of gingival disorders, which are problems related to the gums.
Patients who have a history of dental disorders, which are problems related to the teeth.

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Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
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Universitaetsklinikum Erlangen AöR
Erlangen, Germany

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Investigated drugs

Abatacept
is a medication used to treat rheumatoid arthritis. It works by interfering with the immune system's activity, helping to reduce inflammation and slow down the progression of the disease. In this trial, it is being used to see if it can help reset the immune system in patients with rheumatoid arthritis.
Daratumumab
is a medication that targets specific cells in the immune system. It is commonly used in the treatment of certain types of blood cancers. In this trial, it is being tested to see if it can help reduce the activity of the immune system in patients with rheumatoid arthritis, potentially leading to an improvement in symptoms.

What is already known about the treatment

Abatacept
This medication is administered via intravenous infusion and is used to treat rheumatoid arthritis. It is currently well-established in medical practice and literature as a treatment for this condition. Abatacept works by interfering with the activation of T-cells, which are part of the immune system, thereby reducing inflammation and joint damage. It is classified as a selective co-stimulation modulator.
Daratumumab
This medication is given through intravenous infusion and is primarily used in the treatment of multiple myeloma, but it is being studied for use in rheumatoid arthritis. It is an antibody that targets a specific protein on the surface of plasma cells, leading to their destruction. This action helps in reducing the immune response that contributes to rheumatoid arthritis. Daratumumab is classified as a monoclonal antibody.

Investigated diseases

Rheumatoid arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It occurs when the immune system mistakenly attacks the body's own tissues, leading to inflammation. This inflammation can cause pain, swelling, and stiffness in the joints, often affecting both sides of the body symmetrically. Over time, rheumatoid arthritis can lead to joint damage and deformities. The disease may also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. The progression of symptoms can vary, with periods of increased disease activity, known as flares, and periods of remission.