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About
Primary Objective:
To assess the effect of sarilumab in combination with conventional synthetic Disease-Modifying Anti-Rheumatic Drug (csDMARD) and/or monotherapy on participant-reported impact of disease, using the rheumatoid arthritis impact of disease (RAID) questionnaire, in participants with moderately to severely active rheumatoid arthritis (RA) and inadequate response or intolerance to current csDMARD or tumor necrosis factor (TNF) inhibitors.
Secondary Objectives:
Full description
The study duration per participant was approximately 32 weeks, with up to 4-week screening, 24 weeks treatment period, and 2-4 weeks post-treatment observations.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Inclusion criteria :
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:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Primary purpose
Allocation
Interventional model
Masking
84 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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