D2E7-Early AS

Inclusion Criteria: Patients 18 years of age or older who have moderate to severely active axialspondyloarthritis. Diagnosis made by:Chronic low back pain (duration > 3 months, onset < 50 years of age)plus 3 out of the 6 following criteria (including two of the following three criteria:inflammatory back pain, positive for HLA-B27 and positive MRI showing acute inflammatorylesions in spine or ISG)

• Inflammatory back pain1

• Good or very good response to NSAIDs

• One or more of the following extraspinal manifestations: uveitis, peripheralarthritis, enthesitis

• HLA-B27 positive

• Positive MRI showing acute inflammatory lesions in spine or ISG

• Positive family history for SpA Active disease is defined as a BASDAI score of equalor more than 4, back pain score (BASDAI question 2) of equal or more than 4 despiteconcurrent NSAID therapy, or intolerance to NSAIDs. Other inclusion criteria include: If on prednisone, equal or less than 7.5 mg per day; stable for 4 weeks prior to baseline. An evaluation for latent tuberculosis infection will be performed using a Mendel MantouxTest with 10TE (PPD), reading a chest x-ray, which should have been performed within thelast 12 weeks before inclusion, and history of exposure to infected subjects. Patients whohave evidence of latent TB infection should be given prophylaxis in accordance with localguidelines (Isoniazid 300 mg with adequate substitution of vitamin B6 for 9 months or 600mg Rifampicine for 6 months). The prophylaxis will start 4 weeks before adalimumab isadministered. After 2 weeks of prophylaxis blood tests (liver enzymes, creatinine and bloodcount) will be obtained. Patients with documented prophylaxis in the past need not torepeat this treatment. Women of child bearing potential must have a negative pregnancy test at study baseline anduse an adequate method of contraception (including 3 months after study completion). Sexualactive men must use an accepted method of contraception including 3 months after studycompletion. 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: Definite ankylosing spondylitis (according to modified New York criteria, sacroiliitis ³grade 2 bilaterally or grade 3 to 4 unilaterally) History of active tuberculosis (TB),histoplasmosis or listeriosis. History of positive HIV status. Positive serology forhepatitis B or C indicating active infection, in case of hepatitis B also if indicatingchronic infection History of malignancy other than carcinoma in situ of the cervix oradequately treated non-metastatic squamous or basal cell skin carcinoma. Antibiotic treatment within 3 weeks prior to screening. Treatment with biologicals withinthe last 12 weeks If on DMARDs a washout period of at least 4 weeks is necessary. IfLeflunomide was discontinued, it should be stopped at least 3 months or should be washedout within 4 weeks before study start. History of uncontrolled diabetes, unstable ischemic heart disease, active inflammatorybowel disease, active peptic ulcer disease, recent stroke (within 3 months), ongoingcongestive heart failure, and any other condition which, in the opinion of theinvestigator, would put the subject at risk by participation in the protocol. Female subjects who are pregnant or breast-feeding. Previous diagnosis or signs ofdemyelinating diseases History of systemic lupus erythematosusReceipt of any live (attenuated) vaccines within 4 weeks before screening visit Laboratory exclusions are:hemoglobin level < 8,5 mg/dl, white blood cell count < 3.5 x109/l, platelet count < 125 x 109 /l, creatinine level > 175 µmol/liver enzymes or alkaline phosphatase >2 times theupper limit of normal. Participation in trials of other investigational medications within 30 days of entering thestudy Clinical examination showing significant abnormalities of clinical relevance Historyor current evidence of abuse of ”hard” drugs (e.g. cocaine/heroine) or alcoholism