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A Study of ARRY-371797 in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ARRY-371797, p38 inhibitor; oral
Placebo; oral
Sponsored by
Array Biopharma, now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinic for Rheumatic Diseases
  • Sun Valley Arthritis Center, Ltd
  • Woodland International Research Group
  • NUCATS Institute, Northwestern University
  • Lynn Health Sciences Institute
  • Metroplex Clinical Research Center
  • Sentara Clinical Research Group

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ARRY-371797 (Schedule 1)

ARRY-371797 (Schedule 2)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.

Secondary Outcome Measures

Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
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).

Full Information

First Posted
August 4, 2008
Last Updated
September 17, 2020
Sponsor
Array Biopharma, now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00729209
Brief Title
A Study of ARRY-371797 in Patients With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Array Biopharma, now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARRY-371797 (Schedule 1)
Arm Type
Experimental
Arm Title
ARRY-371797 (Schedule 2)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ARRY-371797, p38 inhibitor; oral
Intervention Description
multiple dose, single schedule
Intervention Type
Drug
Intervention Name(s)
Placebo; oral
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
Time Frame
29 days
Secondary Outcome Measure Information:
Title
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
Time Frame
29 days
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Within 4 weeks of first dose of study drug: anakinra (Kineret®), etanercept (Enbrel®); Within 8 weeks of first dose of study drug: infliximab (Remicade®), adalimumab (Humira®), leflunomide (Arava®); 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Clinic for Rheumatic Diseases
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
Facility Name
Sun Valley Arthritis Center, Ltd
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
NUCATS Institute, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Lynn Health Sciences Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Sentara Clinical Research Group
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

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A Study of ARRY-371797 in Patients With Rheumatoid Arthritis

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