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Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA)

NCT01307423 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 529

Last updated 2022-06-14

Study results available
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Summary

The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis who have not been previously treated with DMARDs.

Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

Conditions

Interventions

DRUG

Apremilast 20mg

Apremilast 20mg twice daily, orally

DRUG

Apremilast 30mg

Apremilast 30mg twice daily, orally

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-09
Primary Completion
2013-02-21
Completion
2017-08-16

Countries

  • United States
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Estonia
  • France
  • Hungary
  • Italy
  • Lithuania
  • New Zealand
  • Poland
  • Romania
  • Russia
  • South Korea
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01307423 on ClinicalTrials.gov