Study of SAR441566 and methotrexate in adults with moderate to severe rheumatoid arthritis

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What is this study about?

This study focuses on people with rheumatoid arthritis, a condition that causes joint inflammation, pain, and stiffness. The research evaluates a new medication called SAR441566 used together with methotrexate in people who have moderate to severe form of the disease. SAR441566 is a substance that works by blocking specific signals that cause inflammation in the body.

The study aims to determine if SAR441566 combined with methotrexate works better than placebo with methotrexate in treating moderate to severe rheumatoid arthritis. The treatment will be given as tablets taken by mouth. The study will last for 12 weeks, during which participants will receive either the study medication or placebo along with their regular methotrexate treatment.

Throughout the study, doctors will monitor how well the treatment works and check for any side effects. They will measure improvements in joint symptoms and overall disease activity. Blood samples will be collected to measure the amount of study medication in the body. This research is conducted as a phase 2 study, which means it is part of the early stages of testing this new treatment.

1 Initial treatment period start

You will receive either SAR441566 tablets or a placebo (inactive substance) to take alongside your current methotrexate treatment

Your current methotrexate dose (between 10-25 mg per week) will remain unchanged during the study

You will continue taking folic/folinic acid supplements as part of your methotrexate treatment

2 Regular monitoring – Week 1 to 12

Your joint pain and swelling will be regularly assessed

Blood tests will be performed to measure C-reactive protein levels (a marker of inflammation)

The study team will monitor how well your body responds to the treatment combination

Blood samples will be taken to measure the levels of study medication in your system

3 12-week assessment

Your progress will be evaluated using the American College of Rheumatology (ACR) scoring system

This assessment measures improvements in your joint symptoms and overall condition

Your disease activity will be measured using a special score called DAS-28 CRP

Any side effects or health changes you experience will be recorded

4 Study completion

The study will evaluate if adding SAR441566 to methotrexate treatment helps improve rheumatoid arthritis symptoms

Your participation will help determine the effectiveness and safety of this new treatment combination

Who Can Join the Study?

  • You must be an adult with rheumatoid arthritis diagnosed at least 3 months ago, with symptoms present for at least 6 months
  • You must have moderate to severe active disease with:
    • At least 6 tender joints
    • At least 6 swollen joints
    • High levels of C-reactive protein (a blood test that measures inflammation) of 4 mg/L or higher
  • You must have been taking methotrexate (a medication that reduces inflammation) for at least 12 consecutive weeks, with a stable dose for at least 6 weeks before screening
  • Your methotrexate dose must be between 10 to 25 mg per week, and you must also take folic or folinic acid supplements
  • You must have shown inadequate response to methotrexate treatment despite proper dose increases
  • Your Body Mass Index (BMI) must be between 18 and 35 (BMI is a measure of body fat based on height and weight)
  • Both men and women can participate

Who Cannot Join the Study?

  • History of active tuberculosis (TB) or other serious infections
  • Presence of severe liver disease (significant problems with liver function)
  • Uncontrolled high blood pressure
  • History of cancer within the past 5 years (except successfully treated non-melanoma skin cancer)
  • Current or recent serious heart conditions including heart failure
  • Pregnant women or women planning pregnancy during the study period
  • Recent treatment with live vaccines (vaccines containing weakened but living microorganisms)
  • Treatment with other biological medications (specialized drugs that target specific parts of the immune system) within the past 3 months
  • Severe allergic reactions to similar medications in the past
  • Presence of other autoimmune diseases (conditions where the immune system attacks the body)
  • Significant kidney problems or abnormal kidney function tests
  • Active or chronic hepatitis B or C infection
  • History of blood disorders or significantly abnormal blood test results
  • Current drug or alcohol abuse
  • Mental health conditions that could interfere with study participation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Revmatologicky Ustav Prague Czechia
Ko-Med Centra Kliniczne Sp. z o.o. Lublin Poland
University General Hospital Of Heraklion Heraklion Greece
Reumed Sp. z o.o. Lublin Poland
Clinicmed Daniluk Nowak Sp. k. Bialystok Poland
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Hamburg Germany
Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak Grodzisk Mazowiecki Poland
Medman s.r.o. Martin Slovakia
Thermium s.r.o. Piestany Slovakia
Medical Plus s.r.o. Uherske Hradiste Czechia
Revmaclinic s.r.o. Brno-Stred Czechia
Hospital Hm Rosaleda Hm La Esperanza Santiago De Compostela Spain
Rheumatologische Schwerpunktpraxis Berlin Germany
Pratia Pardubice a.s. Pardubice Czechia
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
Reum.hapi s.r.o. Nove Mesto Nad Vahom Slovakia
NIEPUBLICZNY ZAKŁAD OPIEKI ZDROWOTNEJ BIF-MED S.C. A. Wawiernia,M. Roykiewicz,R. Roykiewicz Bytom Poland
Rheumazentrum Ratingen Ratingen Germany
Rzjmrywossop srmhnf Brno-Sever Czechia
Edhktuyqyo Kmpmfde Svwfnqj Thessaloniki Greece
Phwreggt Plaobftk Lllofwpj Pnsz Dc Hgw Mxy Pfmru Hodbvm Poznan Poland
Vrbinyed skumht Moravska Ostrava A Privoz Czechia
Ptul Tcbqr Htyrwirs Udypcewtzigi Sabadell Spain
Hhozjwew Udoyvsmnhxqzo du A Colyfa A Coruna Galicia Spain
Ujkgkargzv Gplhdgi Hisknllx Alnzrls Athens Greece

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
14.03.2024
Germany Germany
Not recruiting
14.03.2024
Greece Greece
Not recruiting
14.03.2024
Poland Poland
Not recruiting
14.03.2024
Slovakia Slovakia
Not recruiting
14.03.2024
Spain Spain
Not recruiting
14.03.2024

Trial locations

Investigated drugs:

SAR441566 is an experimental medication that works by blocking a specific protein called TNFR1, which is involved in inflammation. It is being studied as a new treatment for rheumatoid arthritis. This medication is taken together with methotrexate to potentially improve its effectiveness in treating joint inflammation and pain.

Methotrexate is a commonly used medication for treating rheumatoid arthritis. It helps reduce inflammation and slow down joint damage by affecting the immune system. It is considered a standard treatment for rheumatoid arthritis and in this study is used in combination with SAR441566.

Investigated diseases:

Rheumatoid Arthritis – A chronic inflammatory condition that primarily affects the joints throughout the body. The disease occurs when the immune system mistakenly attacks the body’s own tissues, particularly the joint linings, causing inflammation, swelling, and pain. Over time, this inflammation can lead to deterioration of joint cartilage and bones, resulting in joint deformity and reduced mobility. The condition typically affects multiple joints symmetrically, meaning the same joints on both sides of the body are affected. Common symptoms include joint stiffness (especially in the morning), swelling, warmth in affected areas, and fatigue. The disease usually develops gradually, starting with smaller joints in the fingers and toes before potentially progressing to larger joints like knees, hips, and shoulders.

Trial ID:
2023-503910-60-00
Protocol code:
DRI17821
NCT ID:
NCT06073093
Trial Phase:
Therapeutic exploratory (Phase II)

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