Status:
COMPLETED
A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis
Lead Sponsor:
Ablynx, a Sanofi company
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active rheumatoid...
Detailed Description
Subjects who completed the 24-week assessment period and achieved at least 20% improvement in swollen joint count (SJC) and/or tender joint count (TJC) at Week 24 of study ALX0061-C201 were invited to...
Eligibility Criteria
Inclusion
- Diagnosis of RA for at least 6 months prior to screening, and American College of Rheumatology (ACR) functional class I-III
- Subjects treated with and tolerating MTX
- Active RA
- Others as defined in the protocol
Exclusion
- Have been treated with disease-modifying antirheumatic drugs (DMARDs)/systemic immunosuppressives other than MTX.
- Have received approved or investigational biological or targeted synthetic DMARD therapies for RA less than 6 months prior to screening.
- Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs, for RA.
- Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.
- Others as defined in the protocol
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT02309359
Start Date
January 1 2015
End Date
August 1 2016
Last Update
August 21 2019
Active Locations (94)
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1
Investigator Site
Birmingham, Alabama, United States, 35216
2
Investigator Site
Hemet, California, United States, 92543
3
Investigator Site
La Palma, California, United States, 90712
4
Investigator Site
Los Angeles, California, United States, 90017