A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis
2 other identifiers
interventional
25
2 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2008
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 16, 2008
CompletedFirst Submitted
Initial submission to the registry
December 17, 2008
CompletedFirst Posted
Study publicly available on registry
December 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2009
CompletedOctober 19, 2020
October 1, 2020
10 months
December 17, 2008
October 13, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Assess the efficacy of the study drug (versus placebo) in terms of Assessments in Ankylosing Spondylitis 20% Working Group response criterion (ASAS 20).
12 weeks
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
12 weeks
Secondary Outcomes (2)
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
12 weeks
Explore potential biomarkers for pharmacodynamics (PD).
12 weeks
Study Arms (3)
ARRY-371797 (Schedule 1)
EXPERIMENTALARRY-371797 (Schedule 2)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
multiple dose, single schedule
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (12)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Northwestern University
Chicago, Illinois, 60611, United States
Westroads Medical Group
Omaha, Nebraska, 68114, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Low Country Rheumatology
Charleston, South Carolina, 29406, United States
Arthritis Northwest
Spokane, Washington, 99204, United States
Rheumatology Research Associates Group
Edmonton, Alberta, T5M 0H4, Canada
University of Manitoba
Winnipeg, Manitoba, R3A 1M4, Canada
Credit Valley Rheumatology
Mississauga, Ontario, L5M 2V8, Canada
Center de Recherche Musculo-Squelettique
Trois-Rivières, Quebec, G8Z IY2, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2008
First Posted
December 19, 2008
Study Start
December 16, 2008
Primary Completion
September 29, 2009
Study Completion
September 29, 2009
Last Updated
October 19, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
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: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.