A Study of ARRY-371797 in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729209
• Other study ID #: ARRAY-797-103
• Status: Completed
• Phase: Phase 1
• Start date: July 2008
• Est. completion date: April 2009

Study information

• Verified date: September 2020
• Source: Array BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• ARRY-371797, p38 inhibitor; oral
multiple dose, single schedule
• Placebo; oral
matching placebo

Locations

Country	Name	City	State
United States	NUCATS Institute, Northwestern University	Chicago	Illinois
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Woodland International Research Group	Little Rock	Arkansas
United States	Sentara Clinical Research Group	Norfolk	Virginia
United States	Lynn Health Sciences Institute	Oklahoma City	Oklahoma
United States	Sun Valley Arthritis Center, Ltd	Peoria	Arizona
United States	Clinic for Rheumatic Diseases	Tuscaloosa	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Array Biopharma, now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.		29 days
Secondary	Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.		29 days
Secondary	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).		29 days