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Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy

NCT01490450 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2021-11-05

Study results available
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Summary

The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic Disease modifying anti-rheumatic drugs (DMARDs).

Conditions

  • Arthritis, Psoriatic

Interventions

BIOLOGICAL

Placebo matching BMS-945429

Injection, Subcutaneous, 0 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

BIOLOGICAL

BMS-945429

Injection, Subcutaneous, 25 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

BIOLOGICAL

BMS-945429

Injection, Subcutaneous, 100 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

BIOLOGICAL

BMS-945429

Injection, Subcutaneous, 200 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-06-30
Completion
2015-06-30

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Poland
  • Russia
  • South Africa
  • Spain

Study Locations

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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 NCT01490450 on ClinicalTrials.gov