Enbrel-Sulfasalazin-Early-Axial Spondyloarthritis (AS)

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