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A Study of Golimumab in Participants With Active Psoriatic Arthritis

NCT02181673 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2017-12-21

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active psoriatic arthritis (a chronic inflammatory arthritis that is associated with psoriasis).

Conditions

  • Arthritis, Psoriatic

Interventions

DRUG

Placebo

Participants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20 in treatment Group 1 and intravenous infusions of placebo at Week 24 to maintain the blind in treatment Group 2.

DRUG

Golimumab

Participants will receive intravenous infusions of golimumab 2mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52 in treatment Group 2 and intravenous infusions of golimumab (2mg/kg) at Weeks 24, 28 and thereafter every 8 weeks up to Week 52 in treatment Group 1.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-08
Primary Completion
2016-05-05
Completion
2017-03-22

Countries

  • United States
  • Australia
  • Belarus
  • Canada
  • Germany
  • Hungary
  • Lithuania
  • Poland
  • Romania
  • Russia
  • Spain
  • Ukraine

Study Locations

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Entities

Drugs

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 NCT02181673 on ClinicalTrials.gov