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.

Sponsored by:	Incyte Corporation
Information provided by:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00550043

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 II

MedlinePlus related topics: Rheumatoid Arthritis

Study Type:	Observational
Study Design:	Cohort, 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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

Study Population

Rheumatiod arthrtis

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;
- 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;
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

Perrysburg, Ohio, United States, 43551

Middleburg Heights, Ohio, United States, 44130
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

Warszawa, Poland

Elblag, Poland

Konskie, Poland

Sponsors and Collaborators

Incyte Corporation

More Information

Responsible Party:	Incyte Corporation ( Incyte Corporation )
Study ID Numbers:	INCB 18424-231
Study First Received:	October 24, 2007
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00550043
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

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009