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 total study duration for a participant was 16-22 weeks (Part A) and 56-62 weeks (Part B) broken down as follows:
* Screening: Up to 4 weeks
* Treatment: 12 weeks (Part A) and 52 weeks (Part B)\*
* Follow-up: 6 weeks (for participants who would not continue in the long-term extension study).
'\*' Participants successfully completing their treatment period would be offered the opportunity to enter the long term extension study LTS11210 (SARIL-RA-EXTEND) (NCT01146652).
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of rheumatoid arthritis ≥3 months duration
Active disease defined as:
* at least 8/68 tender joints and 6/66 swollen joints,
* high sensitivity C-reactive protein (hs-CRP) \>6 mg/l,
* continuous treatment with MTX for at least 12 weeks prior to baseline visit and on stable dose for at least 6 weeks prior to screening visit.
Part B only:
Bone erosion based on documented X-ray prior to first study drug intake, or
Cyclic Citrullinated Peptide (CCP) positive, or
Rheumatoid Factor (RF) positive.
You may not be if
Age \<18 years or \>75 years.
Treatment with disease-modifying antirheumatic drugs (DMARDs) other than MTX within 4 weeks or 12 weeks prior to screening (depending on DMARDs).
Past history of non-response to prior Tumor Necrosis Factor (TNF) or biologic treatment.
Any past or current biologic agents for the treatment of rheumatoid arthritis within 3 months.
Use of parenteral glucocorticoids or intraarticular glucocorticoids within 4 weeks prior to screening visit.
Use of oral glucocorticoid greater than 10mg/day or equivalent/day, or a change in dosage within 4 weeks prior to baseline visit.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Clareo Health | Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients
