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A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis
A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis

NCT02287922

CompletedPhase 2

Sponsor: Ablynx, a Sanofi company

Conditions: Rheumatoid Arthritis

Interventions: ALX-0061, Placebo, Tocilizumab

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

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 (RA). The secondary objectives of this study are: * To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061 and to explore potential dose regimens for ALX-0061 monotherapy, based on safety and efficacy, for further clinical development. * To obtain parallel descriptive information concerning the efficacy and safety of tocilizumab (TCZ) s.c. in the same clinical trial RA population.

Eligibility overview

Sex: ALL

Age: 18 Years to 74 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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.
Locations (83)
  • 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
  • Orlando, Florida, United States
  • Stockbridge, Georgia, United States
  • Overland Park, Kansas, United States
  • Worcester, Massachusetts, United States
  • Albuquerque, New Mexico, United States
  • New York, New York, United States
  • Charleston, South Carolina, United States
  • Memphis, Tennessee, United States
  • Mesquite, Texas, United States
  • Brussels, Belgium
  • Ghent, Belgium
  • Liège, Belgium
  • Burgas, Bulgaria
  • Pleven, Bulgaria
  • Plovdiv, Bulgaria
  • Plovdiv, Bulgaria
  • Rousse, Bulgaria
  • Rousse, Bulgaria
  • Sofia, Bulgaria
  • Brno, Czechia
  • Olomouc, Czechia
  • Ostrava, Czechia
  • + 53 more on CT.gov