Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT03449758
Eligibility Criteria:
Inclusion criteria :
* Participants with moderately to severely active RA to European League against Rheumatology (EULAR)/American College of Rheumatology (ACR) Criteria.
* Participants with moderate to severe disease activity defined as a DAS28-ESR greater than (\>) 3.2 at Screening.
* Participants with inadequate response within at least the last 3 months or intolerance to current csDMARD or to at least one anti-TNF therapy (as defined by the investigator).
* Oral corticosteroids (less than or equal to \[\<=\] 15 mg/day prednisone or equivalent) and nonsteroidal anti-inflammatory drugs or cyclooxygenase-2 (up to the maximum recommended dose) were allowed if taken at a stable dose for at least 4 weeks prior to Baseline.
* Permitted csDMARDs were allowed if taken at a stable dose for at least 4 weeks prior to Baseline.
* Participants abled and given written informed consent and complied with the requirements of the study protocol.
Exclusion criteria:
* Less than (\<) 18 years of age.
* Participant unable to understand and write adequately to complete the study participant related outcome assessments.
* Exposure to sarilumab at any time prior to Baseline visit.
* Use of intra-articular or parenteral corticosteroids within 4 weeks prior to Baseline.
* Treatment with any investigational agent within the 4 weeks of Screening.
* Last RA treatment prior to inclusion with any anti-Janus kinase (JAK) or biologic DMARD other than anti-TNF.
* Participants treated with anti-TNF (i.e. adalimumab, infliximab, certolizumab, golimumab, etanercept) before the screening period, which are maintained within the 4 weeks before the inclusion (i.e. the first injection of sarilumab).
* Rheumatic autoimmune disease other than RA or prior history or current inflammatory joint disease other than RA.
* Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri previously excised and cured).
* Participant who was institutionalized due to regulatory or legal order or participant who was mentally disabled or educationally disadvantaged.
* Pregnant or breastfeeding woman.
* Women of childbearing potential not protected by highly-effective contraceptive method(s) of birth control (as defined in the informed consent form and/or in a local protocol addendum/amendment) over the study period and for at least 3 months following the last dose of sarilumab, and/or who are unwilling or unable to be tested for pregnancy.
* History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies (or to any of the excipients associated to sarilumab).
* Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline.
* Stage III or IV cardiac failure according to the New York Heart Association classification.
* History of previous gastrointestinal perforation or diverticulitis.
* Known active current/ recurrent infections (including but not limited to active tuberculosis \[TB\] or history of incompletely treated TB and atypical mycobacterial disease, hepatitis B and C, and herpes zoster). NOTE: in case of latent TB infection the participant might be included if a subsequent appropriate anti TB treatment is initiated since at least 3 weeks.
* Positive hepatitis B surface antigen, and/or positive total hepatitis B core antibody, and/or positive hepatitis C antibody at the Screening visit.
* Evidence of serious uncontrolled concomitant disease, including severe uncontrolled hypercholesterolemia or hypertriglyceridemia.
* Participants with any of the following laboratory abnormalities at the Screening or Baseline visit:
* Hemoglobin \<8.5 grams per deciliter.
* White blood cells \<3000/cubic millimeter (mm\^3).
* Absolute neutrophil count \<2000/mm\^3
* Absolute lymphocyte count \<500/mm\^3
* Platelet count \<150 000 cells/mm\^3
* Creatinine clearance \<30 milliliter per minute.
* Aspartate aminotransaminase or Alanine aminotransaminase \>1.5 x upper limit of normal (ULN).
* Bilirubin (total) \>ULN, unless Gilbert's disease has been determined by genetic testing and has been documented
* Total fasting cholesterol \>3.50 gram per liter (g/L) \[9.1 millimoles per liter {mmol/L}\]) or triglycerides \>5.00 g/L \[5.6 mmol/L\]).
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03449758
Study Brief:
Protocol Section:
NCT03449758