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

NCT02287922 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2019-08-21

Study results available
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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

Interventions

BIOLOGICAL

ALX-0061

BIOLOGICAL

Placebo

BIOLOGICAL

Tocilizumab

Sponsors & Collaborators

  • Ablynx, a Sanofi company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor, MD · Ablynx, a Sanofi company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States
  • Belgium
  • Bulgaria
  • Czechia
  • Georgia
  • Germany
  • Hungary
  • Mexico
  • Moldova
  • North Macedonia
  • Poland
  • Romania
  • Serbia
  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02287922 on ClinicalTrials.gov