NCT02287922

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

A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Ablynx, a Sanofi company · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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 (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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	ALX-0061
BIOLOGICAL	Placebo
BIOLOGICAL	Tocilizumab

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2014-11-11
• Last updated: 2019-08-21
• Results posted: 2019-08-21

Locations

83 sites across 14 countries: United States, Belgium, Bulgaria, Czechia, Georgia, Germany, Hungary, Mexico, Moldova, North Macedonia, Poland, Romania, Serbia, Spain