A Study of ARRY-371797 in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00729209
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : April 24, 2012
Information provided by (Responsible Party):
Array BioPharma

Brief Summary:
This is a Phase 1 study, involving a 29-day treatment period, designed to evaluate the pharmacokinetics and the effectiveness of investigational study drug ARRY-371797 in treating rheumatoid arthritis in patients receiving stable doses of methotrexate, and to further evaluate the drug's safety. Approximately 30 patients from the US will be enrolled in this study.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: ARRY-371797, p38 inhibitor; oral Drug: Placebo; oral Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study Start Date : July 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ARRY-371797 (Schedule 1) Drug: ARRY-371797, p38 inhibitor; oral
multiple dose, single schedule
Experimental: ARRY-371797 (Schedule 2) Drug: ARRY-371797, p38 inhibitor; oral
multiple dose, single schedule
Placebo Comparator: Placebo Drug: Placebo; oral
matching placebo

Primary Outcome Measures :
  1. Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations. [ Time Frame: 29 days ]

Secondary Outcome Measures :
  1. Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. [ Time Frame: 29 days ]
  2. Assess the efficacy of study drug (versus placebo) in terms of cross-reactive protein (CRP), the Patient's Assessment of Arthritis Pain (100 mm visual analog scale [VAS]) and urinary N-Telopeptide Cross-Links (NTx). [ Time Frame: 29 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Diagnosed with rheumatoid arthritis (RA) at least 3 months prior to study start based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
  • On a stable weekly dose of both methotrexate (MTX) (10 - 25 mg/week inclusively; either oral or parenteral) and folate (≥ 5 mg weekly ) for ≥ 6 weeks prior to study start and is willing to continue on these regimens for the duration of the study.
  • Meets the ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II, or III.
  • Completed an appropriate washout period if treated with specified therapies.
  • Patients may continue on specified stable background therapy for RA (doses should be stable for at least 6 weeks prior to the first dose of study drug, unless the patient stops due to documented disease improvement, with Sponsor approval).
  • Additional criteria exist.

Key Exclusion Criteria:

  • Diagnosis of any other inflammatory or non-inflammatory arthritis (e.g. spondyloarthritis; fibromyalgia, psoriatic arthritis, crystal-proven gout) that may interfere with disease activity assessments and/or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
  • Has received any of the following prior treatments:

    1. Within 4 weeks of first dose of study drug: anakinra (Kineret®), etanercept (Enbrel®);
    2. Within 8 weeks of first dose of study drug: infliximab (Remicade®), adalimumab (Humira®), leflunomide (Arava®);
    3. At any time: rituximab (Rituxan®), alemtuzumab (CamPath®), any experimental B cell targeting agents.
  • Treatment with potent CYP3A inhibitors or inducers, disease-modifying antirheumatic drugs (DMARDs) and/or biologic response modifiers (BRMs) during the study.
  • Additional criteria exist.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00729209

United States, Alabama
Clinic for Rheumatic Diseases
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
Sun Valley Arthritis Center, Ltd
Peoria, Arizona, United States, 85381
United States, Arkansas
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
United States, Illinois
NUCATS Institute, Northwestern University
Chicago, Illinois, United States, 60611
United States, Oklahoma
Lynn Health Sciences Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75219
United States, Virginia
Sentara Clinical Research Group
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Array BioPharma

Responsible Party: Array BioPharma Identifier: NCT00729209     History of Changes
Other Study ID Numbers: ARRAY-797-103
First Posted: August 7, 2008    Key Record Dates
Last Update Posted: April 24, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases