A Study of ARRY-371797 in Patients With Rheumatoid Arthritis

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: ARRY-371797, p38 inhibitor; oral; Drug: Placebo; oral

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; oral; matching placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.	29 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.	29 days
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

Collaborators and Investigators

• Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: August 4, 2008
• First Submitted That Met QC Criteria: August 4, 2008
• First Posted (Estimate): August 7, 2008

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: ARRAY-797-103