Status:
COMPLETED
A Phase IIb Study for ALX-0061 Monotherapy 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 primary objective of this study is: \- To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (...
Eligibility Criteria
Inclusion
- Diagnosis of RA (according to the 2010 EULAR/American College of Rheumatology (ACR) classification criteria) for at least 6 months prior to screening, and ACR functional class I-III.
- Received previous or current treatment with methotrexate (MTX), and is considered intolerant to MTX, or for whom continued treatment with MTX is inappropriate or has contraindications for MTX use.
- Subjects must not have received MTX for at least 4 weeks before first administration of the study drug.
- Have active RA with at least 6 swollen and 6 tender joints(66/68 joint count) at the time of screening and baseline
- Others as defined in the protocol
Exclusion
- Have been treated with DMARDs (Disease Modifying Antirheumatic Drugs)/systemic immunosuppressive drugs during the 4 weeks, or 12 weeks for hydroxychloroquine, chloroquine, or leflunomide (except when an adequate wash-out procedure for leflunomide was completed), prior to first administration of study drug.
- Have received approved or investigational biological or targeted synthetic DMARD therapies for RA (including tumor necrosis factor alpha-inhibitors, abatacept, rituximab, or Janus kinase \[JAK\]-inhibitors) 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 (including JAK inhibitors), 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 :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT02287922
Start Date
March 1 2015
End Date
July 1 2016
Last Update
August 21 2019
Active Locations (83)
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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