A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis

Incyte Corporation50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

INCB018424DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (15)

Unnamed facility

Huntsville, Alabama, United States

Unnamed facility

Upland, California, United States

Unnamed facility

Gainesville, Florida, United States

Outcomes

Primary Outcomes

The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement

The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: subject's assessment of pain, Subject's global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), subject's self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.

Time frame: Day 28

Secondary Outcomes

The Percentage of Subjects Achieving ACR 50 Improvement

The ACR 50 is defined as ≥ 50% improvement in tender joint count plus ≥ 50% improvement in swollen joint count plus ≥50% improvement in 3 of the following 5 criteria: subject's assessment of pain, PGA, PHGA, subject's self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.

Time frame: Day 28

The Percentage of Subjects Achieving ACR 70 Improvement

The ACR 70 is defined as ≥ 70% improvement in tender joint count plus ≥ 70% improvement in swollen joint count plus ≥ 70% improvement in 3 of the following 5 criteria: subject's assessment of pain, PGA, PHGA, subject's self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.

Time frame: Day 28

Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score

Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus Erythrocyte sedimentation rate (ESR). The DAS28-ESR is expressed as units on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR \<2.6. The mean change from baseline (which represent decreases in the DAS 28 ESR scores) are shown as positive numbers in these analyses.

Time frame: Baseline, Day 28

Data from ClinicalTrials.gov

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