Clinical trial NCT00729209: A Study of ARRY-371797 in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Array BioPharma
Sponsor class: INDUSTRY
First posted: 2008-08-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
timeFrame: 29 days
Secondary outcomes:
measure: Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
timeFrame: 29 days
measure: 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).
timeFrame: 29 days
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Clinic for Rheumatic Diseases
state: Alabama
city: Peoria
country: United States
facility: Sun Valley Arthritis Center, Ltd
state: Arizona
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Chicago
country: United States
facility: NUCATS Institute, Northwestern University
state: Illinois
city: Oklahoma City
country: United States
facility: Lynn Health Sciences Institute
state: Oklahoma
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Norfolk
country: United States
facility: Sentara Clinical Research Group
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: