The total duration of study was expected up to 58 weeks (screening period of 6 weeks, randomized treatment period of 24 weeks and open-label treatment extention period of 24 weeks , and a 4-week post treatment observation).
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult patients 18-75 years of age.
Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria, or 2010 ACR/EULAR for the classification of rheumatoid arthritis.
Moderate to severe active RA with swollen joint count (SJC) ≥ 6(66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
At screening, either High sensitivity C-Reactive Protein (hs-CRP) ≥ 1.5 UNL, or Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour, or Morning stiffness of joint for ≥ 45 minutes.
Inadequate response to methotrexate, having received and tolerated at a dose of 7.5-20 mg/week for ≥ 12 weeks, at a stable dose over the past 4 weeks.
You may not be if
Rheumatic autoimmune disease other than RA.
Use of any biological DMARDs for RA.
Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate
Active infection, or history of serious or chronic infection
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
