PREVENTION OF THE PROGRESSION OF VERY EARLY SYMPTOMSINTO ANKYLOSING SPONDYLITIS: A PLACEBO CONTROLLED TRIAL WITH ETANERCEPT - PREVAS

Wyeth Pharmaceuticals B.V.0 sites80 target enrollmentSeptember 28, 2009

Overview

No summary available.

Registry

who.int

Start Date

September 28, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Wyeth Pharmaceuticals B.V.

•Patients to be included must meet the following criteria.
•\- age between 18\-45 years, both male and female;
•\- inflammatory back pain for at least 3 months, but less than two years
•\- presence of ³2 SpA\-features or
•\- presence of ³1 SpA\-feature with HLA\-B27 positivity or two family members with definite AS (1e or 2e degree family\-member);
•\- no definite sacroiliitis on the X\-ray (sacroiliitis grade 1 is sustained);
•\- active inflammatory lesions on MRI of the sacroiliac\-joint and/or vertebral column
•\- have the capacity to understand and sign an informed consent form, are capable of reading and understanding subject assessment forms, and are willing and able to adhere to the study visit schedule and other protocol requirements.
•\- The screening laboratory test results must meet the following criteria:
•\- hemoglobin for males ³9\.0 g/dL (5\.6 mmol/L) and females ³8\.5 g/dL (5\.3 mmol/L);

•\- definite AS (modified New York criteria (9\);
•\- previous treatment with TNF\-blockers.
•General medical exclusion criteria:
•\- Women who are pregnant, nursing, or planning pregnancy within 2 months after the last; infusion (this includes fathers who plan on fathering a child within 2 months after the last injection);
•\- Documented seropositive for human immunodeficiency virus (HIV);
•\- Documented positive for hepatitis B surface antigen or hepatitis C;
•\- History of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results;
•\- Known history of serious infections (e.g., herpes zoster, cytomegalovirus, pneumocystis carinii, aspergillosis, histoplasmosis, coccidioidomycosis or mycobacteria other than TB) within 6 months prior to screening;
•\- History of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly;
•\- Any current known malignancy or history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence;