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The Controlled Trial of Apremilast for Rheumatoid Arthritis Treatment (CARAT)

NCT01250548 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2014-09-03

No results posted yet for this study

Summary

The purpose of this study is to compare the effects of apremilast with a placebo (an inactive substance that looks like apremilast) on you and other people with rheumatoid arthritis.

The investigators will be collecting information in this study to help us determine -

* the safety of apremilast in patients with active rheumatoid arthritis
* how long it takes for patients with active rheumatoid arthritis to respond to apremilast
* how long the effects of apremilast last after the treatment has ended.

Conditions

Interventions

BIOLOGICAL

apremilast

30 mg BID apremilast taken orally for the first 12 weeks followed by responders randomized to either 30 mg BID apremilast (oral) or 30 mg BID placebo (oral) for 8 weeks

OTHER

Placebo

Sponsors & Collaborators

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • John Cush, MD · Baylor Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

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 NCT01250548 on ClinicalTrials.gov