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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT01250548
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • apremilast — BIOLOGICAL
    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
  • Placebo — OTHER

Study Details

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.

Key Dates

First listed
Dec 1, 2010
Start date
May 31, 2010
Status verified
Sep 2014
Primary completion
Jun 30, 2014
Completion
Jun 30, 2014

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 2
  • Placebo Comparator: Apremilast
    Placebo Compared to apremilast arm

Primary Outcome Measure

To determine the time to response for subjects with active RA taking apremilast (30 mg per os [PO], twice per day [BID]) [ Time Frame: 1.5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor Research Institute - Arthritis Care and Research CenterDallasTexas75231-

Find similar trials in Dallas, TX

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Baylor Research Institute - Arthritis Care and Research Center· Dallas, TX

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