Status:
COMPLETED
Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20-65 years
Phase:
PHASE1
Brief Summary
Primary Objective: To assess the safety and tolerability of a single dose of subcutaneously administered sarilumab in Japanese patients with rheumatoid arthritis (RA) who are receiving concomitant tr...
Detailed Description
Total study duration per patient is up to 88 days 1. Screening: 3 to 28 days 2. Treatment: 1 day 3. Follow-up: 57± 3 days after dosing
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female Japanese who are 20 to 65 years of age
- Diagnosis of rheumatoid arthritis (RA) ≥ 3 months duration
- Treated for a minimum of 8 weeks with Methotrexate (MTX) and with a stable dose of MTX (6-16 mg/week) for a minimum of 4 weeks prior to the screening visit
- Exclusion criteria:
- Autoimmune or inflammatory systemic or localized joint disease other than RA
- Women of a positive pregnancy test
- Latent or active tuberculosis
- Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist
- Treatment with anti-TNF agents, as follows:
- Etanercept: within 28 days prior to randomization
- Infliximab, adalimumab, golimumab, certolizumab pegol: within 42 days prior to randomization
- Received any live, attenuated vaccine within 3 months prior to the randomization visit (eg, varicella-zoster, oral polio, rubella vaccines)
- Significant concomitant illness such as, but not limited to, cardiovascular, renal, neurological, endocrinological, gastrointestinal, hepato-biliary, metabolic, pulmonary or lymphatic disease that would adversely affect the patient's participation in the study.
- Received surgery within 4 weeks prior to the screening visit or planned surgery during the study
- History of a systemic hypersensitivity reaction
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01850680
Start Date
April 1 2013
End Date
December 1 2013
Last Update
January 28 2014
Active Locations (2)
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1
Investigational Site Number 392001
Sendai, Japan
2
Investigational Site Number 392002
Sendai, Japan