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A Study of Guselkumab in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy

NCT03796858 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2025-02-03

No results posted yet for this study

Summary

The purpose of this study is to evaluate guselkumab efficacy versus placebo in participants with active psoriatic arthritis (PsA) and an inadequate response to Anti-Tumor Necrosis Factor Alpha (TNF-alpha) therapy by assessing the reduction in signs and symptoms of joint disease.

Conditions

  • Arthritis, Psoriatic

Interventions

DRUG

Guselkumab 100 mg

Participants will receive guselkumab 100mg as SC injection.

DRUG

Placebo

Participants will receive placebo as SC injection.

Sponsors & Collaborators

  • Janssen Pharmaceutica N.V., Belgium

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutica N.V., Belgium Clinical Trial · Janssen Pharmaceutica N.V., Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-22
Primary Completion
2020-11-11
Completion
2020-11-11

Countries

  • Belgium
  • Bulgaria
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Poland
  • Portugal
  • Russia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

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 NCT03796858 on ClinicalTrials.gov