INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs - Full Text View

Sponsor:	Incyte Corporation
Information provided by:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00902486

Purpose

This will be a randomized, double blind, placebo controlled, dose ranging, parallel group study. Subjects with active rheumatoid arthritis (RA) who have had inadequate response to any disease modifying anti-rheumatic drug (DMARD) therapy including biologics will be enrolled. Screening evaluations will be performed within approximately 28 days of randomization. The duration of the study is 6 months with the primary endpoint assessed at 3 months. Eligible subjects will be randomly assigned to one of three doses (4, 7 or 10 mg QD) of INCB028050 or placebo.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: INCB028050 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients With Active RA With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs (DMARD) Therapy Including Biologics

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

Safety and tolerability of INCB028050 as measured by adverse events, vital signs, clinical laboratory tests and ECGs. [ Time Frame: 3 months of Treatment ] [ Designated as safety issue: No ]
Efficacy as determined by percent of subjects achieving ACR 20 improvement. [ Time Frame: 3 month of Treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of INCB028050 as measured by adverse events, vital signs, clinical laboratory tests and ECGs. [ Time Frame: 6 months of Treatment ] [ Designated as safety issue: No ]
Efficacy as determined by percent of subjects achieving ACR 20, 50, 70 and 90 improvement. [ Time Frame: 6 months of Treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	May 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental INCB028050 4mg QD	Drug: INCB028050 4 mg capsules QD
2: Experimental INCB028050 7mg QD	Drug: INCB028050 7 mg capsules QD
3: Experimental INCB028050 10mg QD	Drug: INCB028050 10 mg capsule QD
4: Placebo Comparator Placebo group may 'cross-over' following 3 months of treatment to receive either active arm #2 (7mg QD) or active arm #3 (10mg QD) of INCB028050 capsules.	Drug: Placebo Placebo matching INCB028050 QD

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must have rheumatoid arthritis which has been inadequately controlled with at least one DMARD
For subjects receiving antimalarials, they must be treated with antimalarials for at least 6 months and receiving a stable daily dose
For subjects receiving sulfasalazine, they must be treated with SSZ for at least 6 months and receiving a stable daily dose of no more than 3 grams per day
For subjects on methotrexate, they must be treated with methotrexate for at least 6 months, and receiving a stable weekly dose of methotrexate between 10 and 25 mg
For subjects on leflunomide, they must be treated with leflunomide for at least 6 months, and receiving a stable dose of leflunomide between 10 to 20 mg
For subjects receiving corticosteroids, they must be on a dose not to exceed 10 mg of prednisone daily
Active rheumatoid arthritis at the time of screening defined by the following: 6 or more joints tender or painful on motion and 4 or more swollen joints and at least one of the following two: ESR greater than or equal to 28 mm/hr or CRP greater than or equal to 10 mg/liter..
Have evidence of lack of risk for tuberculosis

Exclusion Criteria:

Current or recent viral, bacterial, fungal, parasitic or mycobacterial infection requiring systemic therapy
History of infected joint prosthesis
Subjects who have a current or recent history of severe, progressive, uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease
Subjects who have received treatment with the following drugs or drug classes within the specified timeframe: prior treatment with rituximab within 12 months, prior treatment with an oral JAK inhibitor, DMARDs or other anti-rheumatic therapies not specified and allowed according to protocol, treatment with any investigational medication within 12 weeks or 5 half-lives (whichever is longer), and treatment with a biologic agent within 12 weeks prior to the first dose of study medication.
Subjects with a past history of neutropenia, thrombocytopenia or anemia requiring transfusion other than at the time of trauma or surgery, and subjects that meet protocol specified laboratory measures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902486

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Locations

United States, Alabama

Birmingham, Alabama, United States
United States, Arizona

Paradise Valley, Arizona, United States

Peoria, Arizona, United States

Phoenix, Arizona, United States
United States, California

Palm Desert, California, United States

Santa Maria, California, United States

Santa Monica, California, United States

Westlake Village, California, United States

Whittier, California, United States
United States, Colorado

Denver, Colorado, United States
United States, Florida

Aventura, Florida, United States

Daytona Beach, Florida, United States

Gainesville, Florida, United States

Lake Mary, Florida, United States

Naples, Florida, United States

Palm Harbor, Florida, United States

Sarasota, Florida, United States
United States, Illinois

Springfield, Illinois, United States
United States, Indiana

South Bend, Indiana, United States
United States, Kansas

Wichita, Kansas, United States
United States, Kentucky

Lexington, Kentucky, United States
United States, Maryland

Wheaton, Maryland, United States
United States, Missouri

St. Louis, Missouri, United States
United States, Nebraska

Lincoln, Nebraska, United States
United States, New Jersey

Freehold, New Jersey, United States
United States, New York

Syracuse, New York, United States
United States, North Carolina

Charlotte, North Carolina, United States

Hickory, North Carolina, United States
United States, Ohio

Middleburg Heights, Ohio, United States

Toledo, Ohio, United States
United States, Oklahoma

Tulsa, Oklahoma, United States
United States, Pennsylvania

Duncansville, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States
United States, Texas

Houston, Texas, United States
United States, Virginia

Arlington, Virginia, United States
United States, Washington

Spokane, Washington, United States
Czech Republic

Brno, Czech Republic

Ceska Lipa, Czech Republic

Chomutov, Czech Republic

Hlucin, Czech Republic

Hustopece, Czech Republic

Kromeriz, Czech Republic

Praha, Czech Republic

Zlin, Czech Republic

Sponsors and Collaborators

Incyte Corporation

Investigators

Study Director:

Monica E. Luchi, MD

Incyte Corporation

More Information

No publications provided

Responsible Party:	Incyte Corporation ( Pamela Murphy, VP of Investor Relations and Corporate Management )
ClinicalTrials.gov Identifier:	NCT00902486 History of Changes
Other Study ID Numbers:	INCB 28050-201
Study First Received:	May 13, 2009
Last Updated:	June 18, 2010
Health Authority:	United States: Food and Drug Administration

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
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 07, 2010