A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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 arthritis (RA) despite MTX therapy, compared with placebo. To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061, based on safety and efficacy, for further clinical development.

Key facts

Study ID

NCT02309359

Run by

Ablynx, a Sanofi company

People needed

345

Starts

2015-01-01

Expected to finish

2016-08-01

Last updated by the study team

2019-08-21

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigator Site — Hemet, California, United States
• Investigator Site — La Palma, California, United States
• Investigator Site — Los Angeles, California, United States
• Investigator site — Los Angeles, California, United States
• Investigator Site — Ventura, California, United States
• Investigator Sites — Hialeah, Florida, United States
• Investigator Site — Homestead, Florida, United States
• Investigator Site — Miami, Florida, United States
• Investigator Site — Miami Lakes, Florida, United States
• Investigator Site — Orlando, Florida, United States
• Investigator Site — Stockbridge, Georgia, United States
• Investigator Site — Overland Park, Kansas, United States
• Investigator Site — Monroe, Louisiana, United States
• Investigator Site — Worcester, Massachusetts, United States
• Investigator Site — Albuquerque, New Mexico, United States
• Investigator Site — Brooklyn, New York, United States
• Investigator Site — New York, New York, United States
• Investigator Sie — Charleston, South Carolina, United States
• Investigator Site — Myrtle Beach, South Carolina, United States
• Investigator Site — Memphis, Tennessee, United States
• Investigator Site — Mesquite, Texas, United States
• Investigator Site — Brussels, Belgium
• Investigator Site — Brussels, Belgium
• Investigator Site — Ghent, Belgium
• Investigator Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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