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
1 other identifier
interventional
50
2 countries
15
Brief Summary
The purpose of this study is to understand the safety and tolerability of INCB018424 in patients with rheumatoid arthritis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 rheumatoid-arthritis
Started Oct 2007
Shorter than P25 for phase_2 rheumatoid-arthritis
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 24, 2007
CompletedFirst Posted
Study publicly available on registry
October 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
March 23, 2015
CompletedMarch 23, 2015
March 1, 2015
11 months
October 24, 2007
February 9, 2015
March 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
The Percentage of Subjects Achieving ACR 50 Improvement
Day 28
The Percentage of Subjects Achieving ACR 70 Improvement
Day 28
Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score
Baseline, Day 28
Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score
Baseline, Day 28
Percentage of Subjects Who Achieved DAS 28 ESR Low Disease
Day 28
- +3 more secondary outcomes
Study Arms (5)
Cohort 1: Treatment Group A
EXPERIMENTALINCB018424 15 mg twice daily (BID) or matching placebo
Cohort 2: Treatment Group B
EXPERIMENTALINCB018424 5 mg BID or matching placebo
Cohort 2: Treatment Group C
EXPERIMENTALINCB018424 25 mg BID or matching placebo
Cohort 2: Treatment Group D
EXPERIMENTALINCB018424 50 mg once daily (QD) or matching placebo
Placebo
PLACEBO COMPARATORMatching placebo, oral
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Upland, California, 91786, United States
Unknown Facility
Gainesville, Florida, 32607, United States
Unknown Facility
Palm Harbor, Florida, 34684, United States
Unknown Facility
Kalispell, Montana, 59901, United States
Unknown Facility
Hickory, North Carolina, 28601, United States
Unknown Facility
Mayfield Village,, Ohio, 44143, United States
Unknown Facility
Middleburg Heights, Ohio, 44130, United States
Unknown Facility
Perrysburg, Ohio, 43551, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15261, United States
Unknown Facility
Hixson, Tennessee, 37343, United States
Unknown Facility
Memphis, Tennessee, 38119, United States
Unknown Facility
Elblag, Poland
Unknown Facility
Gmina Końskie, Poland
Unknown Facility
Warsaw, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Incyte Corporation
Study Officials
- STUDY DIRECTOR
Monica Luchi, MD
Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2007
First Posted
October 26, 2007
Study Start
October 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
March 23, 2015
Results First Posted
March 23, 2015
Record last verified: 2015-03