A Study of ARRY-371797 in Patients With Active Ankylosing... | NCT00811499

ID	Type	Description	Link
C4411006	Other Identifier	Pfizer

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 16, 2008Actual

Primary Completion Date

Sep 29, 2009Actual

Completion Date

Sep 29, 2009Actual

First Submitted Date

Dec 17, 2008

First Submission Date that Met QC Criteria

Dec 17, 2008

First Posted Date

Dec 19, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Dec 8, 2009

Certification/Extension First Submitted that Passed QC Review

Dec 8, 2009

Certification/Extension First Posted Date

Dec 10, 2009Estimated

Last Update Submitted Date

Oct 13, 2020

Last Update Posted Date

Oct 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
ARRY-371797 (Schedule 1)	Experimental	Drug: ARRY-371797, p38 inhibitor; oral
ARRY-371797 (Schedule 2)	Experimental	Drug: ARRY-371797, p38 inhibitor; oral Drug: Placebo; oral
Placebo	Placebo Comparator	Drug: Placebo; oral

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARRY-371797, p38 inhibitor; oral	Drug	multiple dose, single schedule	ARRY-371797 (Schedule 1) ARRY-371797 (Schedule 2)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Cedars-Sinai Medical Center		Los Angeles	California	90048	United States
Northwestern University

IPD Sharing Statement Module

Plan to Share IPD

Yes

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/data\_requests.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

ID	Term
D000089183	Axial Spondyloarthritis
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D000844	Ankylosis
D007592	Joint Diseases
D001168	Arthritis