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 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT02373202
Eligibility Criteria:
Inclusion criteria:
Diagnosis of rheumatoid arthritis (RA), according to the American College of Rheumatology/The European League Against Rheumatism (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria with \>=3 months disease duration.
Moderately to severely active RA defined as:
* At least 4 of 68 tender joints and 4 of 66 swollen joints at screening visit.
* High sensitivity C-Reactive Protein (hs-CRP) \>=4 mg/L or Erythrocyte Sedimentation Rate (ESR) \>=28 mm/hr at screening visit.
For the combination stratum:
Participants who had continuous treatment with non-biologic DMARDs other than MTX for at least 12 weeks prior to the randomization and on a stable dose for a minimum of 6 weeks prior to screening.
For the monotherapy stratum:
Participants who per investigator judgment were any of inappropriate, intolerant or inadequate to MTX treatment.
Exclusion criteria:
Participants \<20 years of age. Prior treatment with tumor necrosis factor (TNF) antagonists or any other RA-directed biologic agents without the appropriate off-drug period prior to screening.
Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.
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:
20 Years
Study:
NCT02373202
Study Brief:
Protocol Section:
NCT02373202