Study of Apremilast to Evaluate the Safety and Effectiveness for Patients With Rheumatoid Arthritis

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apremilast 30 mg — DRUG
  30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
• Apremilast 20 mg — DRUG
  20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
• Placebo — DRUG
  Oral Placebo tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in active treatment / active treatment extension phase. Participants who are nonresponders will advance early to 20 mg Apremilast BID at Week 16.

Study Details

The purpose of this study is to determine whether Apremilast is safe and effective in the treatment of patients with rheumatoid arthritis, specifically in improving signs and symptoms of rheumatoid arthritis (tender and swollen joints, pain, physical function and structure) in treated patients who have had an inadequate response to Methotrexate.

Key Dates

First listed

Jan 28, 2011

Start date

Dec 9, 2010

Status verified

Apr 2020

Primary completion

Feb 21, 2012

Completion

Sep 10, 2012

Study Design

Enrollment

237 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Apremilast 30 mg
• Experimental: Apremilast 20 mg
• Placebo Comparator: Placebo

Primary Outcome Measure

Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Week 16 [ Time Frame: Baseline and Week 16 ]

Locations (29)

Find similar trials in Gilbert, AZ

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