Study on Rosnilimab for Patients with Moderate to Severe Rheumatoid Arthritis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Rosnilimab in individuals with Moderate to Severe Rheumatoid Arthritis. Rheumatoid arthritis is a condition where the immune system mistakenly attacks the joints, causing pain and swelling. The study aims to evaluate how effective and safe Rosnilimab is in treating this condition. Rosnilimab is administered as a solution for injection under the skin.

The trial is designed to compare the effects of Rosnilimab with a placebo, which is a substance with no active medication. Participants will be randomly assigned to receive either Rosnilimab or the placebo. The study will last for several weeks, during which participants will receive regular injections and attend scheduled visits for monitoring. The main goal is to observe changes in the severity of rheumatoid arthritis symptoms over time.

Throughout the study, participants will be closely monitored for any changes in their condition and any side effects they might experience. The study will assess various outcomes, such as the reduction in joint pain and swelling, and the overall improvement in disease activity. The results will help determine the potential benefits of Rosnilimab for people living with moderate to severe rheumatoid arthritis.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either the study medication, rosnilimab, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

2 medication administration

The study medication, rosnilimab, is administered as a solution for injection. It is given subcutaneously, which means it is injected under the skin.

The dosage and frequency of administration will be determined by the study protocol and communicated to the participant at the start of the trial.

3 monitoring and assessments

Throughout the study, participants will undergo regular monitoring and assessments to evaluate the effectiveness and safety of the treatment.

These assessments will include measuring changes in disease activity using the DAS28-CRP score, which is a measure of rheumatoid arthritis activity based on joint counts and blood tests.

4 primary evaluation

The primary evaluation will occur at Week 12, where the main focus will be on the mean change from baseline in the DAS28-CRP score.

This evaluation will help determine the primary efficacy of the treatment.

5 secondary evaluations

Secondary evaluations will also take place at Week 12, assessing various response rates such as ACR20, ACR50, and ACR70, which indicate different levels of improvement in rheumatoid arthritis symptoms.

Additional assessments will include the proportion of participants achieving low disease activity or remission based on DAS28-CRP and CDAI scores.

6 completion of study

The study is expected to conclude by March 2026. Participants will be informed of the study’s outcomes and any relevant findings related to their health and treatment.

Who Can Join the Study?

The person must be an adult, male or female, who is 18 years or older when they agree to join the study.
If the person is a woman who can have children, she must have a negative pregnancy test before starting the study and agree to use a strong method of birth control during the study and for 24 weeks after the last dose of the study treatment.
Women must agree not to donate eggs during the study and for 24 weeks after the last dose of the study treatment.
Men must use a condom during any sexual activity that could lead to pregnancy and use condoms with spermicide from the first dose of the study treatment until 150 days after the last dose if they are sexually active with a woman who can have children.
Men must agree not to donate sperm during the study and for 150 days after the last dose of the study treatment.
The person must be willing to participate, not be restricted by any local laws, and be able to give written consent to join the study.
The person must be willing to follow all study procedures and be available for the entire duration of the study.
The person must have a clinical diagnosis of active Rheumatoid Arthritis (RA), which is a condition that causes joint pain and swelling, for at least 3 months before starting the study.
The person must be considered in good health by the study doctor, except for their RA, based on their medical history, lab tests, physical exam, and heart test results.
The person must have a positive test result for Rheumatoid Factor (RF) or antibodies to Cyclic Citrullinated Peptide (CCP), which are markers often found in people with RA.
The person must have moderate to severe RA, shown by having at least 6 tender and 6 swollen joints at the start of the study.
The person must have a high-sensitivity C-reactive protein (hs-CRP) level of 3 mg/L or higher, which is a marker of inflammation in the body.
The person must be taking at least one, but not more than two, specific medications for RA for at least 3 months before the study and be on stable doses for at least 8 weeks before starting the study. These medications include Methotrexate, Leflunomide, Sulfasalazine, Hydroxychloroquine, or Chloroquine.
The person must meet certain criteria for Tuberculosis (TB) screening, which is a serious lung infection. They should have no history of active or latent TB, or if they have a history of latent TB, they must have completed or be receiving treatment for it. They must also have a negative TB test result before starting the study.
The person must have no signs of cancer or active infections, including TB, based on a chest X-ray or CT scan done within 6 months before starting the study.

Who Cannot Join the Study?

Patients with any other serious health condition that could interfere with the study.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have received any other experimental drug within the last 30 days.
Patients who are pregnant or breastfeeding.
Patients with a history of allergic reactions to similar medications.
Patients with a history of drug or alcohol abuse.
Patients who have been diagnosed with cancer in the past five years.
Patients with uncontrolled high blood pressure.
Patients with severe liver or kidney disease.
Patients who have had a major surgery in the past three months.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Innomedica OÜ	Tallin	Estonia
Twoja Przychodnia Opolskie Centrum Medyczne	Opole	Poland

Other Sites

Site Name	City	Country
Centre Hospitalier Jean Rougier	Cahors	France
Artromac N.O.	Kosice	Slovakia
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH	Hamburg	Germany
Rheumatologische Schwerpunktpraxis	Berlin	Germany
Rheuma Medicus Sp. z o.o.	Warsaw	Poland
Accellacare Espana S.L.	Alcobendas	Spain
Mortnjyiu Iqvjvoenwi Cmifgsgn Sqdzqlyr Sll z ohrr	Warsaw	Poland
Ccxdxfhfa Uizfqwcmujnqci Sbgyuffgw	Woluwe-Saint-Lambert	Belgium
Amfewdb Ofpqfbmicde du Pgfsxm	Padua	Italy
Udhifxaocq Oq Dwcwdief	Debrecen	Hungary
Hrrsyfxv Vgxs dujyfxmk	Barcelona	Spain
Nywtf Eqwzqni Mcwmuha Cddtqe Fsktokhyrp	Tallin	Estonia
Acul Gzmqxy Otooqpuj Mukvttiakxmby Nlbadzax	Milan	Italy
Fjtxrdiakf Iidei Pnuxxjthhrk Skz Mvqcji	Pavia	Italy
Ccvwau Hsmyzdsayyb Ufrtudrgnenhp Du Mkqizdspglf	Montpellier	France
Uuhydeamnxhi Dg Shcygdzg Db Cszywtyafw	Santiago De Compostela	Spain
Gbzhyqowsccywsc Asrzvygea	Antwerp	Belgium
Agmiuiw Owtkzlldsfenyczxkvvzihpas Mbfpvtoc Deogg Cjkpyk	Novara	Italy
Czauym hluuxitbwni udenaaemymcpy dd Ldied	Liege	Belgium
Tvzrn Pfsmtwfcdst Ppkcppntxq Csfyudv Mzllmebo Syk z olxv	Poznan	Poland
Cyvjewc Gfejx Seewemcj	Santiago De Compostela	Spain
Mjx Pdubtrj Svq z oluy	Poznan	Poland
Hjmrht Figwffetnk Vjljwhiuuysuygzwc Gsjj	Gommern	Germany
Kfsdbuircvm Ueuuatnbd Kcygva Og	Tartu	Estonia
Blkygrfwpp Iedbznfmbzbx Bvuyq Ijkasavfwuvpx Kfhayz	Budapest	Hungary
Obeivw Etqlbhsagjwye Cnbhvka Kqfy	Dunaújváros	Hungary
Nfoloacrkqmk Zidtxq Ojqudi Zsdltpnofg Bomrmmm Sgur Am Wegzyneirter Rqkicomfdmflt Rwuhodqben	Bytom	Poland
Ubnoqphincgitqhqn Cdwugr Bguacznyxx Dg Rnpj	Rome	Italy
Svm Eozgyxzwh Gkuqvg Ggcg Kagafouzpbj Krpwmleh Ramebiwhad	Herne	Germany
Hamroz Kwaglswu Siunenjn Gykz	Schwerin	Germany
Kbjzdkgfd Fhcqeyfiw Hyqtzzfwesmect Gpqm	Hanover	Germany
Acdy Cncmau Suummevkznkhs Otqzzopimf Ttohdoshohskpr Gcwqmvv Prcg Cov	Milan	Italy
Hlnxsxoq Udaksacbtqgfw Bojknmj	Bilbao	Spain
Mqpcyu srwvew	Martin	Slovakia
Tgski Pwtohmebfkb Nexouohasdd Cgdbfyf Mujljfnr Ssg z ohyj	Nowa Sol	Poland
As Chcoieh Mrahqzex Scj z olpt	Poznan	Poland
Qzuihaedyde Kqlt	Budapest	Hungary
Nuek Rqrnz Dmcocxkbhgm I Rgwfintwak Lqrdwgq Raqjnzwmgye I Fhijncacopdtpm shpes	Bialystok	Poland
Njtbuxo Udbia Ryxvygacamkt Cblsps	Piestany	Slovakia

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.03.2024
Estonia	Not recruiting	01.03.2024
France	Not recruiting	01.03.2024
Germany	Not recruiting	01.03.2024
Hungary	Not recruiting	01.03.2024
Italy	Not recruiting	01.03.2024
Poland	Not recruiting	01.03.2024
Slovakia	Not recruiting	01.03.2024
Spain	Not recruiting	01.03.2024

Trial locations

Investigated Drugs:

Rosnilimab

Rosnilimab is a medication being studied for its effectiveness and safety in treating moderate to severe rheumatoid arthritis. It is designed to help reduce inflammation and pain in the joints, which are common symptoms of this condition. The trial aims to determine how well this medication works compared to not receiving the active treatment.

Investigated Diseases:

Rheumatoid arthritis

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically causes pain, swelling, and stiffness in the joints, often starting in the hands and feet. Over time, it can lead to joint damage and deformities. The disease progresses through periods of flares and remissions, where symptoms can worsen or improve. It can also affect other parts of the body, including the skin, eyes, and lungs. The exact cause is unknown, but it involves the immune system attacking the body’s own tissues.

Trial ID:

2023-504564-42-00

Protocol code:

ANB030-203

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Rosnilimab for Patients with Moderate to Severe Rheumatoid Arthritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?