NCT00729209

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

9 months

First QC Date

August 4, 2008

Last Update Submit

September 17, 2020

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

    29 days

Secondary Outcomes (2)

  • 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

Study Arms (3)

ARRY-371797 (Schedule 1)

EXPERIMENTAL
Drug: ARRY-371797, p38 inhibitor; oral

ARRY-371797 (Schedule 2)

EXPERIMENTAL
Drug: ARRY-371797, p38 inhibitor; oral

Placebo

PLACEBO COMPARATOR
Drug: Placebo; oral

Interventions

ARRY-371797, p38 inhibitor; oralDRUG

multiple dose, single schedule

ARRY-371797 (Schedule 1)ARRY-371797 (Schedule 2)
Placebo; oralDRUG

matching placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Clinic for Rheumatic Diseases

Tuscaloosa, Alabama, 35406, United States

Location

Sun Valley Arthritis Center, Ltd

Peoria, Arizona, 85381, United States

Location

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

NUCATS Institute, Northwestern University

Chicago, Illinois, 60611, United States

Location

Lynn Health Sciences Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75219, United States

Location

Sentara Clinical Research Group

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ARRY-371797

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2008

First Posted

August 7, 2008

Study Start

July 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

September 21, 2020

Record last verified: 2020-09

Locations

US(7)