OHSU

IRB #

IRB00009690

Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of Tofacitinib in Subjects with Active Ankylosing Spondylitis (AS)

Principal Investigator

Atulya Deodhar

Study Purpose

This study represents the first investigation of tofacitinib in subjects with active AS. It is designed to obtain more information on the safety, pharmacokinetics and clinical efficacy of 3 different doses of tofacitinib in this population.

Medical Condition(s)

Ankylosing Spondylitis

Eligibility Criteria

Inclusion Criteria:
*18 years or older
*Diagnosis of AS
*BASDAI ≥4 and Back Pain ≥4
*Have active disease activity despite use of non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to NSAIDS
*MTX and Sulfasalazine can be used and must be continued throughout study with dosages unchanged; however other DMARDs must be discontinued through a washout period before starting the study
*No evidence of TB
*Subjects cannot be pregnant or plan to become pregnant during study

Exclusion Criteria:
*Subjects current or previous use of TNF inhibitors or other biological agents
*any prior treatment with alkylating agents
*subject with a history of malignancy with the exception of certain types of skin cancer that was removed and adequately treated or cervical cancer that was located just in the cervix

Age Range

18 - 90

Healthy Volunteers Needed

No

Duration of Participation

up to 20 weeks, 12 weeks of receiving treatment and follow up at week 16 (all subjects who complete the study must have a Follow-up visit within 28 days (+/-7 days) of the last dose)

Minors Included

No

Contact

Margaret Sels
Clinical Research Coordinator
Division of Arthritis & Rheumatic Diseases
Oregon Health & Science University
3181 SW Sam Jackson Park Road, Mail Code: OP-09
Portland, OR 97239

sels@ohsu.edu
Phone: (503) 494-5742
Fax: (503) 494-1022

Sponsor

Pfizer

Recruitment End

01/01/2015

Compensation Provided

Yes

Compensation

Subjects would receive about $50 for each study visit completed. If they complete the entire study they could receive up to $350.


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