Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)
Overview
- Phase
- Phase 1
- Intervention
- Sarilumab
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 105
- Primary Endpoint
- PD parameters
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The main purposes of this study are to describe the pharmacodynamic effects, safety and pharmacokinetics of a single dose of sarilumab.
Investigators
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.
Arms & Interventions
Sarilumab - dose 1
Single subcutaneous (SC) injection of Sarilumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Intervention: Sarilumab
Sarilumab - dose 2
Single SC injection of Sarilumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
Intervention: Sarilumab
Tocilizumab - dose 1
Single intravenous (IV) administration of Tocilizumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Intervention: Tocilizumab
Tocilizumab - dose 2
Single IV administration of Tocilizumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
Intervention: Tocilizumab
Outcomes
Primary Outcomes
PD parameters
Time Frame: baseline through week 4
Pharmacodynamic (PD) parameters, what a drug does to the body, will be collected from baseline through week 4: * the time to nadir (or peak) * change from baseline * area under the curve (AUC)
Secondary Outcomes
- Percentage of TEAEs(baseline through week 6)
- PK parameters(baseline through week 4)