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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:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00550043
First received: October 24, 2007
Last updated: June 28, 2010
Last verified: June 2010

October 24, 2007
June 28, 2010
October 2007
September 2008   (final data collection date for primary outcome measure)
Safety: the incidence of adverse events, ECG, Vital signs and clinical laboratory evaluation. Efficacy: The percentage of subjects achieving ACR improvement. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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
Preliminary population pharmacokinetics and pharmacodynamics of INCB018424 in patients with active rheumatoid arthritis. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
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
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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Rheumatiod arthrtis

Rheumatoid Arthritis
Not Provided
  • 1
    Cohort 1: 15 mg BID - 16 total (12 active and 4 placebo)
  • 2
    Cohort 2: 2 dose levels - 32 total (24 active and 8 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;
    • DMARDs or other anti-rheumatic therapies not specified above including but not limited to: sulfasalazine, gold, penicillamine, dapsone, azathioprine, 6-mercaptopurine, cholorambucil, 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
No
Contact information is only displayed when the study is recruiting subjects
United States,   Poland
 
NCT00550043
INCB 18424-231
No
Incyte Corporation
Incyte Corporation
Not Provided
Not Provided
Incyte Corporation
June 2010

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