Status:
COMPLETED
Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 di...
Detailed 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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03449758
Start Date
March 5 2018
End Date
July 31 2019
Last Update
April 28 2022
Active Locations (33)
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1
Investigational Site Number 250007
Argenteuil, France
2
Investigational Site Number 250006
Besançon, France, 25030
3
Investigational Site Number 250027
Bobigny, France, 93000
4
Investigational Site Number 250016
Bordeaux, France, 33076