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

NCT02309359 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2019-08-21

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

ALX-0061

OTHER

Placebo

DRUG

Methotrexate

Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Sponsors & Collaborators

  • Ablynx, a Sanofi company

    lead INDUSTRY

Principal Investigators

  • Ablynx Clinical Department · 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
2015-01-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

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

Study Locations

More Related Trials

Entities

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 NCT02309359 on ClinicalTrials.gov