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

Other Sites

Site Name City Country Status
Centre hospitalier universitaire de Liege Liege Belgium
Klinische Forschung Hannover-Mitte GmbH Hanover Germany
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto Milan Italy
Hospital Universitario Basurto Bilbao Spain
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
Qualiclinic Kft. Budapest Hungary
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Hamburg Germany
Artromac N.O. Kosice Slovakia
Narodny Ustav Reumatickych Chorob Piestany Slovakia
Medman s.r.o. Martin Slovakia
Accellacare Espana S.L. Alcobendas Spain
Rheuma Medicus Sp. z o.o. Warsaw Poland
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p. Bialystok Poland
Ai Centrum Medyczne Sp. z o.o. Poznan Poland
Centre Hospitalier Jean Rougier Cahors France
Rheumatologische Schwerpunktpraxis Berlin Germany
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Azienda Ospedaliera di Padova Padua Italy
University Of Debrecen Debrecen Hungary
Med Polonia Sp. z o.o. Poznan Poland
Kliiniliste Uuringute Keskus OÜ Tartu Estonia
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universidade De Santiago De Compostela Santiago De Compostela Spain
Gasthuiszusters Antwerpen Antwerp Belgium
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
HELIOS Kliniken Schwerin GmbH Schwerin Germany
NIEPUBLICZNY ZAKŁAD OPIEKI ZDROWOTNEJ BIF-MED S.C. A. Wawiernia,M. Roykiewicz,R. Roykiewicz Bytom Poland
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
North Estonia Medical Centre Foundation Tallin Estonia
Msipsfnjp Iesjnxxvnj Cpguixog Swjcmgxp Soc z ozlj Warsaw Poland
Cbpwflghq Ubxteuuadxvwwk Skhoedibt Woluwe-Saint-Lambert Belgium
Hfvmms Fdqgejizpx Vztbpyfijrdqqkhsj Gkiu Gommern Germany
Bviavithft Ilnjtgmmdbze Bzjlt Ixssknwbrgvvr Kauuen Budapest Hungary
Htygaflc Vqmg dlwxdjut Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

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

Trial locations

Investigated drugs:

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 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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