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
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
Drug: INCB018424
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: October 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550043

Locations
United States, Alabama
Huntsville, Alabama, United States, 35801
United States, California
Upland, California, United States, 91786
United States, Florida
Gainesville, Florida, United States, 32607
Palm Harbor, Florida, United States, 34684
United States, Montana
Kalispell, Montana, United States, 59901
United States, North Carolina
Hickory, North Carolina, United States, 28601
United States, Ohio
Mayfield Village,, Ohio, United States, 44143
Middleburg Heights, Ohio, United States, 44130
Perrysburg, Ohio, United States, 43551
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15261
United States, Tennessee
Hixson, Tennessee, United States, 37343
Memphis, Tennessee, United States, 38119
Poland
Elblag, Poland
Konskie, Poland
Warszawa, Poland
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Monica Luchi, MD Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00550043     History of Changes
Other Study ID Numbers: INCB 18424-231
Study First Received: October 24, 2007
Results First Received: February 9, 2015
Last Updated: March 9, 2015
Health Authority: United States: Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Incyte Corporation:
Rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on March 26, 2015