Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)
Rheumatoid Arthritis
About this trial
This is an interventional basic science trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Patients with RA as defined by the 2010 revised American College of Rheumatology (ACR)
- ACR Class I-III functional status, based on the 1991 revised criteria
- Treated for a minimum of 12 weeks with Methotrexate with a stable dose of MTX for at least 8 weeks prior to screening visit
Exclusion Criteria:
- Patients less than 18 years of age or minimum legal age
- Prior treatment with any biologic anti-Interleukin 6 (IL-6) or IL-6 Receptor (IL-6R) antagonists
- Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening
- Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks prior to randomization
- Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening visit, whichever is longer
- Treatment with oral/ biologic DMARDs (disease-modifying antirheumatic drugs), other than MTX, within a certain amount of time prior to screening visit
- Active or suspected TB or at high risk of contracting TB
- Fever, or chronic, persistent, or recurring infections requiring active treatment
- HIV positive
Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Active Comparator
Sarilumab - dose 1
Sarilumab - dose 2
Tocilizumab - dose 1
Tocilizumab - dose 2
Single subcutaneous (SC) injection of Sarilumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Single SC injection of Sarilumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
Single intravenous (IV) administration of Tocilizumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Single IV administration of Tocilizumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)