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

NCT00811499

Last updated date
Study Location
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankylosing Spondylitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ankylosing Spondylitis
Intervention  ICMJE
  • Drug: ARRY-371797, p38 inhibitor; oral
    multiple dose, single schedule
  • Drug: Placebo; oral
    matching placebo
  • Drug: Placebo; oral
    multiple dose, single schedule
Study Arms  ICMJE
  • Experimental: ARRY-371797 (Schedule 1)
    Intervention: Drug: ARRY-371797, p38 inhibitor; oral
  • Experimental: ARRY-371797 (Schedule 2)
    Interventions:
    • Drug: ARRY-371797, p38 inhibitor; oral
    • Drug: Placebo; oral
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo; oral
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 8, 2009)
25
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2008)
168
Actual Study Completion Date  ICMJE September 29, 2009
Actual Primary Completion Date September 29, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00811499
Other Study ID Numbers  ICMJE ARRAY-797-201
C4411006 ( Other Identifier: Pfizer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP