Back to resultsA Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
INCB018424
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis
Eligibility Criteria
Inclusion Criteria:
- Established diagnosis of rheumatoid arthritis
- 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:
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;
- Treatment with any investigational medication within 12 weeks prior to the first dose of study medication.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Cohort 1: Treatment Group A
Cohort 2: Treatment Group B
Cohort 2: Treatment Group C
Cohort 2: Treatment Group D
Placebo
Arm Description
INCB018424 15 mg twice daily (BID) or matching placebo
INCB018424 5 mg BID or matching placebo
INCB018424 25 mg BID or matching placebo
INCB018424 50 mg once daily (QD) or matching placebo
Matching placebo, oral
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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).
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00550043
Brief Title
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
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to understand the safety and tolerability of INCB018424 in patients with rheumatoid arthritis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: Treatment Group A
Arm Type
Experimental
Arm Description
INCB018424 15 mg twice daily (BID) or matching placebo
Arm Title
Cohort 2: Treatment Group B
Arm Type
Experimental
Arm Description
INCB018424 5 mg BID or matching placebo
Arm Title
Cohort 2: Treatment Group C
Arm Type
Experimental
Arm Description
INCB018424 25 mg BID or matching placebo
Arm Title
Cohort 2: Treatment Group D
Arm Type
Experimental
Arm Description
INCB018424 50 mg once daily (QD) or matching placebo
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo, oral
Intervention Type
Drug
Intervention Name(s)
INCB018424
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement
Description
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 Outcome Measure Information:
Title
The Percentage of Subjects Achieving ACR 50 Improvement
Description
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
Title
The Percentage of Subjects Achieving ACR 70 Improvement
Description
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
Title
Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score
Description
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
Title
Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score
Description
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).
Time Frame
Baseline, Day 28
Title
Percentage of Subjects Who Achieved DAS 28 ESR Low Disease
Description
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.
Time Frame
Day 28
Title
Percentage of Subjects Who Achieved DAS 28 CRP Low Disease
Description
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.
Time Frame
Day 28
Title
Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease
Description
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.
Time Frame
Day 28
Title
Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease
Description
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.
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Established diagnosis of rheumatoid arthritis
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:
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;
Treatment with any investigational medication within 12 weeks prior to the first dose of study medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Luchi, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
City
Mayfield Village,
State/Province
Ohio
ZIP/Postal Code
44143
Country
United States
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
City
Hixson
State/Province
Tennessee
ZIP/Postal Code
37343
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
City
Elblag
Country
Poland
City
Konskie
Country
Poland
City
Warszawa
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis
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