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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
History of Changes
  Purpose

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


Condition Phase
Rheumatoid Arthritis
 Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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:

U.S. FDA Resources

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Preliminary population pharmacokinetics and pharmacodynamics of INCB018424 in patients with active rheumatoid arthritis. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Rheumatiod arthrtis

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;
    • 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.
  Contacts and Locations
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
Middleburg Heights, Ohio, United States, 44130
Perrysburg, Ohio, United States, 43551
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
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
  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
Last Updated: June 28, 2010
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
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013