Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/8/2015 |
Start Date: | March 2014 |
End Date: | March 2015 |
Contact: | Clinical Trials Administrator |
Email: | clinicaltrial@regeneron.com |
The main purposes of this study are to describe the pharmacodynamic effects, safety and
pharmacokinetics of a single dose of sarilumab.
pharmacokinetics of a single dose of sarilumab.
Inclusion Criteria:
1. Patients with RA as defined by the 2010 revised American College of Rheumatology
(ACR)
2. ACR Class I-II functional status, based on the 1991 revised criteria
3. 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:
1. Patients less than 18 years of age or minimum legal age
2. Prior treatment with any biologic anti-Interleukin 6 (IL-6) or IL-6 Receptor (IL-6R)
antagonists
3. Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks
prior to screening
4. 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
5. 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
6. Treatment with oral/ biologic DMARDs (disease-modifying antirheumatic drugs), other
than MTX, within a certain amount of time prior to screening visit
7. Active or suspected TB or at high risk of contracting TB
8. Fever, or chronic, persistent, or recurring infections requiring active treatment
9. 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.
We found this trial at
17
sites
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