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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00550043
First received: October 24, 2007
Last updated: March 9, 2015
Last verified: March 2015

October 24, 2007
March 9, 2015
October 2007
September 2008   (final data collection date for primary outcome measure)
The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
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.
Safety, tolerability and preliminary efficacy of 28 days of dosing of INCB018424 in patients with active rheumatoid arthritis. [ Time Frame: 28 days ]
Complete list of historical versions of study NCT00550043 on ClinicalTrials.gov Archive Site
  • The Percentage of Subjects Achieving ACR 50 Improvement [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    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.
  • The Percentage of Subjects Achieving ACR 70 Improvement [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

    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.

  • Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score [ Time Frame: Baseline, Day 28 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score [ Time Frame: Baseline, Day 28 ] [ Designated as safety issue: No ]
    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).
  • Percentage of Subjects Who Achieved DAS 28 ESR Low Disease [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Subjects Who Achieved DAS 28 CRP Low Disease [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
    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.
Preliminary population pharmacokinetics and pharmacodynamics of INCB018424 in patients with active rheumatoid arthritis.
Not Provided
Not Provided
 
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: INCB018424
  • Drug: Placebo
  • Experimental: Cohort 1: Treatment Group A
    INCB018424 15 mg twice daily (BID) or matching placebo
    Intervention: Drug: INCB018424
  • Experimental: Cohort 2: Treatment Group B
    INCB018424 5 mg BID or matching placebo
    Intervention: Drug: INCB018424
  • Experimental: Cohort 2: Treatment Group C
    INCB018424 25 mg BID or matching placebo
    Intervention: Drug: INCB018424
  • Experimental: Cohort 2: Treatment Group D
    INCB018424 50 mg once daily (QD) or matching placebo
    Intervention: Drug: INCB018424
  • Placebo Comparator: Placebo
    Matching placebo, oral
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2008
September 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Poland
 
NCT00550043
INCB 18424-231
No
Not Provided
Not Provided
Incyte Corporation
Incyte Corporation
Not Provided
Study Director: Monica Luchi, MD Incyte Corporation
Incyte Corporation
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP