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

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

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

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Placebo; Drug: INCB018424

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Poland
  • Elblag, Poland
  • Konskie, Poland
  • Warszawa, Poland
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
  • California
    • Upland, California, United States, 91786
  • Florida
    • Gainesville, Florida, United States, 32607
    • Palm Harbor, Florida, United States, 34684
  • Montana
    • Kalispell, Montana, United States, 59901
  • North Carolina
    • Hickory, North Carolina, United States, 28601
  • Ohio
    • Mayfield Village,, Ohio, United States, 44143
    • Middleburg Heights, Ohio, United States, 44130
    • Perrysburg, Ohio, United States, 43551
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
  • Tennessee
    • Hixson, Tennessee, United States, 37343
    • Memphis, Tennessee, United States, 38119

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Treatment Group A; INCB018424 15 mg twice daily (BID) or matching placebo	Drug: INCB018424
Experimental: Cohort 2: Treatment Group B; INCB018424 5 mg BID or matching placebo	Drug: INCB018424
Experimental: Cohort 2: Treatment Group C; INCB018424 25 mg BID or matching placebo	Drug: INCB018424
Experimental: Cohort 2: Treatment Group D; INCB018424 50 mg once daily (QD) or matching placebo	Drug: INCB018424
Placebo Comparator: Placebo; Matching placebo, oral	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, Day 28
Change From Baseline in Disease Activity Score 28 (DAS 28) CRP 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 C-reactive protein (CRP). A higher score indicated more disease activity. The mean change from baseline (which represent decreases in the DAS 28 CRP scores) are shown as positive numbers in these analyses. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).	Baseline, Day 28
Percentage of Subjects Who Achieved DAS 28 ESR Low Disease	Subjects who achieved low disease activity based on the DAS 28 ESR (score <3.2). Subjects who achieved low disease activity were classified as responders in this analysis.	Day 28
Percentage of Subjects Who Achieved DAS 28 CRP Low Disease	Subjects who achieved low disease activity based on the DAS 28 CRP (score <3.2). Subjects who achieved low disease activity were classified as responders in this analysis.	Day 28
Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease	Subjects who achieved inactive disease based on the DAS 28 ESR (score <2.6). Subjects who achieved low disease activity were classified as responders in this analysis.	Day 28
Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease	Subjects who achieved inactive disease based on DAS 28 CRP (score <2.6). Subjects who achieved low disease activity were classified as responders in this analysis.	Day 28

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Monica Luchi, MD, Incyte Corporation

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: October 24, 2007
• First Submitted That Met QC Criteria: October 24, 2007
• First Posted (Estimate): October 26, 2007

Study Record Updates

• Last Update Posted (Estimate): March 23, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Rheumatoid arthritis
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: INCB 18424-231