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Study edits or deletions are displayed in red. Study additions are displayed in green. Scroll up to access the controls. Oversight U. FDA-regulated Drug: U.
Study Description Brief Summary: Based on published data and according to the approved product label for ankylosing spondylitis and psoriatic arthritis, it can be expected that adalimumab 40 mg every 14 days should be effective in psoriatic arthritic patients with axial involvement. Study drug will be subcutaneously self-administered every 2 weeks during Outcome Measures Primary Outcome Measures: 1. To assess the improvement in metrology, functionality, enthesitis, peripheral arthritis, extraarticular manifestations, laboratory parameters and quality of life.
A negative pregnancy test for women of childbearing potential during the screening period. Axial disease according to radiological criteria at least unilateral sacroilitis grade II and spinal inflammatory symptoms.
UNA TRAYECTORIA, UNA MANERA DE SENTIR Y EJERCER LA ABOGACÍA
Prior treatment with other TNF inhibitors. Uncontrolled diabetes. Uncontrolled high blood pressure. Unstable ischemic heart disease. Congestive heart failure. Severe pulmonary disease. Chronic leg ulcer.
Humberto Rosell Becerril
History of cancer or malignant lymphoproliferative disease. History of positive serology for Hepatitis B indicating active infection or history of 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.
History of 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. And patients where an intraarticular corticoid infiltration has been practised within the last 4 weeks before the screening will be excluded from the study.
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Prior treatment with any TNF blocking agent or other biologic agents. 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.