Status:
COMPLETED
A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
Primary Objective: -To demonstrate that sarilumab added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Japanese RA participants with an inadequate response to MTX. S...
Detailed Description
The total duration of study was expected up to 62 weeks (screening period of 4 weeks, treatment period of 52 weeks, and a 6-week post treatment observation).
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosis of RA, according to the American College of Rheumatology/The European League Against Rheumatism (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria with \>=3 months disease duration.
- Moderately to severely active RA defined as:
- At least 8 of 68 tender joints and 6 of 66 swollen joints at screening visit.
- High sensitivity C-Reactive Protein (hs-CRP) \>=6mg/L at screening visit.
- Exclusion criteria:
- Participants \<20 or \>75 years of age.
- Treatment with any Disease-modifying antirheumatic drug (DMARD) other than MTX or biologic agent without the appropriate off-drug period prior to screening.
- Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT02293902
Start Date
November 1 2014
End Date
October 1 2016
Last Update
January 30 2018
Active Locations (96)
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1
Investigational Site Number 392010
Asahi-Shi, Japan
2
Investigational Site Number 392001
Asahikawa-Shi, Japan
3
Investigational Site Number 392035
Asahikawa-Shi, Japan
4
Investigational Site Number 392070
Beppu-Shi, Japan