Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT02309359

CompletedPhase 2

Sponsor: Ablynx, a Sanofi company

Conditions: Rheumatoid Arthritis

Interventions: ALX-0061, Placebo, Methotrexate

Countries: United States, Belgium, Bulgaria, Czechia, Georgia, Germany, Hungary, Mexico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 74 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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
Locations (94)
  • Birmingham, Alabama, United States
  • Hemet, California, United States
  • La Palma, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Ventura, California, United States
  • Hialeah, Florida, United States
  • Homestead, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Orlando, Florida, United States
  • Stockbridge, Georgia, United States
  • Overland Park, Kansas, United States
  • Monroe, Louisiana, United States
  • Worcester, Massachusetts, United States
  • Albuquerque, New Mexico, United States
  • Brooklyn, New York, United States
  • New York, New York, United States
  • Charleston, South Carolina, United States
  • Myrtle Beach, South Carolina, United States
  • Memphis, Tennessee, United States
  • Mesquite, Texas, United States
  • Brussels, Belgium
  • Brussels, Belgium
  • Ghent, Belgium
  • Liège, Belgium
  • Pleven, Bulgaria
  • Plovdiv, Bulgaria
  • Rousse, Bulgaria
  • Rousse, Bulgaria
  • + 64 more on CT.gov