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A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00811499
Recruitment Status : Terminated
First Posted : December 19, 2008
Last Update Posted : October 19, 2020
Information provided by (Responsible Party):

Brief Summary:
This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-371797 (versus placebo) in treating ankylosing spondylitis, and to further evaluate the drug's safety. Approximately 130 patients from the US, Canada, Poland and Hungary will be enrolled in this study.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: ARRY-371797, p38 inhibitor; oral Drug: Placebo; oral Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : December 16, 2008
Actual Primary Completion Date : September 29, 2009
Actual Study Completion Date : September 29, 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Drug: Placebo; oral
multiple dose, single schedule

Placebo Comparator: Placebo Drug: Placebo; oral
matching placebo

Primary Outcome Measures :
  1. Assess the efficacy of the study drug (versus placebo) in terms of Assessments in Ankylosing Spondylitis 20% Working Group response criterion (ASAS 20). [ Time Frame: 12 weeks ]
  2. Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations. [ Time Frame: 12 weeks ]
  2. Explore potential biomarkers for pharmacodynamics (PD). [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Diagnosis of ankylosing spondylitis according to the Modified New York Criteria (1984).
  • Inadequate response to at least 2 weeks of continuous treatment with NSAIDs, or unable to receive ≥ 2 full weeks of continuous treatment with NSAIDs because of intolerance.
  • If previously treated with a biological agent, patient must not have failed due to lack of efficacy, and must have completed an appropriate washout period prior to first dose of study drug.
  • Patients may continue on specified stable background therapies for ankylosing spondylitis (doses should be stable for at least 4 weeks prior to the first dose of study drug).
  • Additional criteria exist.

Key Exclusion Criteria:

  • Diagnosis of any other active or uncontrolled inflammatory or non-inflammatory articular disease that may interfere with disease activity assessments.
  • Previously treated with intravenous immunoglobulins within 6 months prior to first dose of study drug.
  • Patients requiring prohibited concomitant medications including moderate or strong CYP3A inhibitors, CYP3A inducers and Biologic Response Modifiers (BRMs) while on study.
  • Trauma or other major surgeries within 8 weeks prior to first dose of study drug.
  • Specific abnormal laboratory values or electrocardiogram abnormalities.
  • Known positive serology for human immunodeficiency virus (HIV), hepatitis C, and/or hepatitis B.
  • Additional criteria exist.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00811499

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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Nebraska
Westroads Medical Group
Omaha, Nebraska, United States, 68114
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, South Carolina
Low Country Rheumatology
Charleston, South Carolina, United States, 29406
United States, Washington
Arthritis Northwest
Spokane, Washington, United States, 99204
Canada, Alberta
Rheumatology Research Associates Group
Edmonton, Alberta, Canada, T5M 0H4
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3A 1M4
Canada, Ontario
Credit Valley Rheumatology
Mississauga, Ontario, Canada, L5M 2V8
Canada, Quebec
Center de Recherche Musculo-Squelettique
Trois-Rivieres, Quebec, Canada, G8Z IY2
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
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Responsible Party: Pfizer Identifier: NCT00811499    
Other Study ID Numbers: ARRAY-797-201
C4411006 ( Other Identifier: Pfizer )
First Posted: December 19, 2008    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at:
Additional relevant MeSH terms:
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Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases