SPARTA – spondyloarthritis remission trial after adalimumab - SPARTA

Department of Rheumatology, Hvidovre Hospital0 个研究点开始时间: 2007年4月19日最近更新: 2016年7月21日

适应症

试验速览

暂无简介。

•1. At least 12 months of treatment with a) adalimumab 40 mg subcutaneously every other week, or b) subcutneous injection of Etanercept 25 mg twice weekly or Etanercept 50 mg once a week or c) infusion of Infliximab 3 mg/kg or 5 mg/kg every 6 to 8 week
•2. Diagnosis of spondylarthritis according to the European Spondyloarthritis Study Group (ESSG) criteria (Dougados et al, Arthritis Rheum 1991; 34: 1218-27) or ankylosing spondylitis according to the modified New York Criteria
•3. No clinical active disease, defined as a BASDAI score < 4 (equal to 40 mm on a 100 mm Visual Analogue Scale) on 2 consecutive timepoints with at least 3 months between
•4. An X-ray or MRI made before initiation of TNF-alpha inhibitor that showed features confirming previous sacroiliitis, or active inflammatory changes on MRI
•5. Among other issues: Age >18 years, able to give informed consent, no contraindications for anti-TNFa-therapy
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Treatment with disease modifying anti-rheumatic drugs (DMARDs) are accepted during the study, but no changes in the dose is allowed.
•2. Oral, intraarticular, intramuscular or intravenous glukokorticoid within 4 weeks before screening
•3. Pregnancy or lactation - patients who wants to get pregnant (male or female) can take part in the first 6 months of the study, because they have to use sufficient contraceptives in 6 moths after withdrawal of TNF-alpha inhibitors
•4. HIV, hepatitis B or C, tuberculosis, other infections
•5. Malignancies
•6. Other serious concomitant diseases (uncontrolled/severekidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological ore cerebral disease (including demyelinating disease)
•7. Contraindications to anti-TNFa-therapy
•8. Contraindications to MRI

发起方

Department of Rheumatology, Hvidovre Hospital