A Study of ARRY-371797 in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT00729209
First received: August 4, 2008
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: ARRY-371797, p38 inhibitor; oral
Drug: Placebo; oral
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Resource links provided by NLM:


Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations. [ Time Frame: 29 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: July 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729209

Locations
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
  More Information

No publications provided

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00729209     History of Changes
Other Study ID Numbers: ARRAY-797-103
Study First Received: August 4, 2008
Last Updated: April 23, 2012
Health Authority: United States: Food and Drug Administration

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 October 19, 2014