ABOUT THIS STUDY
- 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.
- 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
- severe internal medical diseases such as severe cardiac, hepatic, gastrointestinal,
neurological, psychiatric diseases
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