Enbrel-Sulfasalazin-Early-Axial Spondyloarthritis (AS)

• Status: Unknown status
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Efficacy - To assess efficacy of etanercept versus sulfasalazine when added to NSAIDs in patients with moderate to severe active early axial spondyloarthritis duration of ongoing axial symptoms of less than 5 years. Primary outcome is change of active inflammatory lesions in sacroiliac joints and spine as detected by MRI at 12 months. Secondary outcome parameters are clinical and laboratory efficacy parameters and MRI changes at 6 months and 2 years. Comparisons will be made within the two treatment arms and compared to baseline. At the 1 year extension phase comparisons will be also made between year 1 and year 2. At the end of the extended study a pelvic x-ray is planned.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Etanercept; Sulfasalazine

Criteria

Inclusion Criteria:

• Patients 18 - 50 years of age who have moderate to severe active axial spondyloarthritis.

• Diagnosis made by :Chronic low back pain (duration > 3 months, onset < 45 years of age)plus 3 out of the 6 following criteria if imaging is positive or 4 out of the following 6 criteria if imaging is negative ·

• Inflammatory back pain:

• Good or very good response to NSAIDs

• One or more of the following extraspinal manifestations: uveitis, peripheral arthritis, enthesitis, HLA-B27 positive

• Positive imaging: MRI showing acute inflammatory lesions in spine or SIJ (in the past) or bilateral sacroiliitis grade 2-4 or unilateral sacroiliitis grade 3-4 in x-ray not older than 12 months

• Positive family history for SpA

• MRI at screening showing acute inflammatory lesions in SIJ or spine

• Active disease is defined as:

• a BASDAI score of >=4

• back pain score (BASDAI question 2) of >= 4 despite concurrent NSAID therapy, or intolerance to NSAIDs.

• Other inclusion criteria include, if on prednisone:

• <7.5 mg per day

• stable for 4 weeks prior to baseline

• Women of child bearing potential must have a negative pregnancy test at study baseline and use an adequate, effective method of contraception for a duration of 6 months after stop of etanercept therapy. Sexual active men must use an accepted method of contraception for a duration of 6 months after stop of etanercept therapy.

• Reading a normal chest/lung x-ray which should have been performed within the last 12 weeks before inclusion

• Able to self-administer injectable drug supplies or have a caregiver who will do so.

• Able to store injectable test article at 2° to 8° C.

Exclusion Criteria:

• Disease duration of longer than 5 years

• History of active tuberculosis (TB), histoplasmosis or listeriosis.

• History of positive HIV status, known hepatitis B or C

• History of malignancy other than carcinoma in situ of the cervix or adequately treated non-metastatic squamous or basal cell skin carcinoma.

• Antibiotic treatment within 3 weeks prior to screening.

• Previous treatment with TNF-alpha blockers

• Treatment with sulasalazine in the last 6 months before participation in the clinical trial

• severe internal medical diseases such as severe cardiac, hepatic, gastrointestinal, neurological, psychiatric diseases