A 24 Week Open Label Study of the Utility of Adalimumab in Active Axial Forms of Psoriatic Arthritis

Patients with active axial forms of psoriatic arthritis

Inclusion Criteria:

• Males and females aged between 18 and 70 years.
• A negative pregnancy test for women of childbearing potential during the screening period.
• Subject must be evaluated for active or latent TB (tuberculosis) infection by using a PPD skin test (Mantoux test), Booster test, chest x-ray and detailed review of subjetc´s medical history.
• Subjects to whom the doctor has decided to prescribe adalimumab, because of fulfilling the requirements for this treatment.
• Diagnosed with PsA according to CASPAR criteria.
• Axial disease according to radiological criteria (at least unilateral sacroilitis grade II) and spinal inflammatory symptoms.
• Disease duration of no less than 24 weeks
• Patients with peripheral involvement (mixed forms of APs) must have been taking MTX for at least 12 weeks before screening and at stable doses of 10 to 25 mg/week for 8 weeks before screening, or salazopyrine up to 3 mg/daily, or cyclosporin 2mg/kg or leflunomide 20 mg daily in the same conditions as MTX.
• Patient's doses of NSAIDs and oral corticosteroids (≤ 10 mg/day of prednisone or equivalent) should have been kept stable for 4 weeks before screening.

Exclusion Criteria:

• Contraindications for treatment with anti-TNF.
• Prior treatment with other TNF inhibitors or other investigational drugs during the last 30 days (etanercept 4 weeks, infliximab 8 weeks).
• Uncontrolled diabetes.
• Uncontrolled high blood pressure.
• Unstable ischemic heart disease.
• Congestive heart failure.
• Severe pulmonary disease.
• Chronic leg ulcer.
• History of cancer or malignant lymphoproliferative disease.
• Positive serology for Hepatitis B indicating active infection or positive serology for Hepatitis C.
• History of positive HIV status.
• Persistent, recurrent or severe infections requiring hospitalization or treatment with oral antibiotics within 14 days prior to enrollment.
• Previous diagnosis or signs highly indicative of central nervous system demyelinating diseases.
• Active tuberculosis, histoplasmosis or listeriosis.
• History or presence of confirmed blood dyscrasia.
• Female subjects who are pregnant or breast-feeding.
• History of clinically significant drug or alcohol abuse in the last year.
• Treatment with MTX, salazopyrine, ciclosporin or leflunomide initiated within the last 4 weeks before the screening. Treatment with corticosteroids (>10mg/day or equivalent or modified dose within the previous 4 weeks before screening). And patients where an intraarticular corticoid infiltration has been practised within the last 4 weeks before the screening will be excluded from the study.
• Treatment with more than one NSAID within the last 4 weeks before the screening.
• Patients treated with any DMARD different from MTX, cyclosporine, leflunomide and sulfasalazine.
• Dosage of concomitant MTX, cyclosporine, leflunomide and sulfasalazine must be stable during the study, otherwise it should be properly justified and recorded in the case report form.
• Patients treated with any analgesic different from acetominophen, NSAIDs, oxycodone, codeine, propoxyphene, tramadol, hydrocodone or combinations of these products or equivalents. The use of potent opioids is not permitted.