Clinical trial NCT00811499: A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ankylosing Spondylitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assess the efficacy of the study drug (versus placebo) in terms of Assessments in Ankylosing Spondylitis 20% Working Group response criterion (ASAS 20).
timeFrame: 12 weeks
measure: Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
timeFrame: 12 weeks
Secondary outcomes:
measure: Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
timeFrame: 12 weeks
measure: Explore potential biomarkers for pharmacodynamics (PD).
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Omaha
country: United States
facility: Westroads Medical Group
state: Nebraska
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Charleston
country: United States
facility: Low Country Rheumatology
state: South Carolina
city: Spokane
country: United States
facility: Arthritis Northwest
state: Washington
city: Edmonton
country: Canada
facility: Rheumatology Research Associates Group
state: Alberta
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Mississauga
country: Canada
facility: Credit Valley Rheumatology
state: Ontario
city: Trois-Rivieres
country: Canada
facility: Center de Recherche Musculo-Squelettique
state: Quebec
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: