Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
With
Regeneron Pharmaceuticals
The duration of the study period for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-week double-blind treatment period and 6-week safety follow-up period.
Participants who completed the 12-week treatment period were offered enrollment in a separate long-term extension study (LTS11210/NCT01146652).
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of rheumatoid arthritis ≥6 months duration and American College of Rheumatology (ACR) Class I-III functional status at screening and baseline visits;
Active disease defined as:
* At least 6 of 68 tender joints and 6 of 66 swollen joints at screening and baseline visits, and
* hs-C-Reactive Protein (hs-CRP) \>10 g/L or Erythrocyte Sedimentation Rate (ESR) \>28 mm/hr at screening visit;
Continuous treatment with Methotrexate for at least 12 weeks and on stable dose (minimum 10 mg/week) for at least 6 weeks prior to the screening visit;
Participant considered as Primary TNF-α blocker nonresponder. i.e.:
* Appropriate for previous TNF-α blocker therapy
* Lack of adequate clinical response after at least 3 months TNF-α blocker therapy with MTX or other synthetic disease modifying anti-rheumatic drug (DMARD) co-therapy.
You may not be if
Age \<18 years or \>75 years;
Pregnant or breastfeeding woman or woman of childbearing potential, unwilling to utilize adequate contraception or not to become pregnant during the entire study;
Fever (\>38°C), or chronic, persistent, or recurring infection(s);
History of demyelinating disease;
Current underlying hepatobiliary disease.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
