Clinical trial NCT00550043: A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis
Official title: A Double-blind, Placebo-controlled Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2007-10-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to understand the safety and tolerability of INCB018424 in patients with rheumatoid arthritis


Eligibility criteria: Inclusion Criteria:

1. Established diagnosis of rheumatoid arthritis
2. Patients receiving methotrexate must be treated with for at least 6 months and receiving a stable weekly dose between 10 and 25 mg for at least 8 consecutive weeks prior to study entry.

Exclusion Criteria:

1. Patients who have taken the following drugs within the timeframe below:

   * Leflunomide, infliximab, etanercept, adalimumab, abatacept, or other biological therapies (except rituximab) - Within 12 weeks prior to the first dose of study medication;
   * Rituximab - Within 12 months prior to the first dose of study medication;
   * Disease-modifying anti-rheumatic drugs (DMARDs) or other anti-rheumatic therapies not specified above including but not limited to: gold, penicillamine, dapsone, azathioprine, 6-mercaptopurine, chlorambucil, cyclophosphamide, cyclosporin, mycophenolate mofetil - Within 12 weeks prior to the first dose of study medication;
2. Treatment with any investigational medication within 12 weeks prior to the first dose of study medication.

Primary outcomes:
measure: The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement
timeFrame: Day 28
Secondary outcomes:
measure: The Percentage of Subjects Achieving ACR 50 Improvement
timeFrame: Day 28
measure: The Percentage of Subjects Achieving ACR 70 Improvement
timeFrame: Day 28
measure: Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score
timeFrame: Baseline, Day 28
measure: Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score
timeFrame: Baseline, Day 28
measure: Percentage of Subjects Who Achieved DAS 28 ESR Low Disease
timeFrame: Day 28
measure: Percentage of Subjects Who Achieved DAS 28 CRP Low Disease
timeFrame: Day 28
measure: Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease
timeFrame: Day 28
measure: Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease
timeFrame: Day 28
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Upland
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Kalispell
country: United States
state: Montana
city: Hickory
country: United States
state: North Carolina
city: Mayfield Village,
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Perrysburg
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Hixson
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Elblag
country: Poland
city: Konskie
country: Poland
city: Warszawa
country: Poland
Study officials:
affiliation: Incyte Corporation
name: Monica Luchi, MD
role: STUDY_DIRECTOR
References: