Ankylosing Spondylitis Clinical Trial
Official title:
Threecenter Placebo Controlled Three Arm Trial in Patients With Active Ankylosing Spondylitis With Prednisolone
1. to investigate whether steroids are effective in ankylosing spondylitis
2. if steroids are effective to describe how quick they work
Status | Recruiting |
Enrollment | 75 |
Est. completion date | August 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. ankylosing spondylitis according to the modified NY criteria 1984 2. age between 18 and 70 years 3. insufficient response to therapy with NSAIDs 4. BASDAI > 4 5. Previous therapy with DMARDs (such as sulfasalazine, methotrexate etc.) or steroids less than or equal to 7,5mg is allowed, should be discontinued or stable 4 weeks before study start 6. written informed consent Exclusion Criteria: 1. Pregnancy or lactation 2. current severe infection or during the last 3 months 3. suspected opportunistic infection during the past 2 months (such as Herpes zoster, cytomegaly-, Pneumocystis carinii-infection), HIV-infection 4. Malignancies 5. severe cardial, renal, hematological, endocrinological, pulmonal, gastrointestinal (such as peptic ulcers) neurological, hepatic (viral or toxic hepatitis) concomitant disease, uncontrolled arterial hypertension remitting thrombosis, embolism 6. Diabetes mellitus or increased blood glucose test 7. uncontrolled glaucoma 8. active immunization during the past 2 weeks or planned for the next 8 weeks 9. pathologic laboratory test results: creatinine >200 µmol/l, liver enzymes > 2,5 fold, AP >2,5 fold upper normal ranges 10. significant pathological changes during physical examination 11. clinical trial participation during the past 30 days before screening 12. intake of "hard drugs" (such as cocaine, heroin) 13. therapy with more than 7,5 mg prednisolone, intraarticular steroids during the past 4 weeks before study start 14. current application for retirement |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Charité Campus Benjamin-Franklin Rheumatolgy | Berlin | |
Germany | Immanuel Hospital Rheumatology | Berlin | |
Germany | Rheumazentrum Ruhrgebiet | Herne |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 50% improvement of BASDAI after 14 days of treatment | |||
Secondary | Improvement of pain on a VAS 0 - 10 | |||
Secondary | Decrease of CRP/ BSG | |||
Secondary | Number of swollen/tender joints | |||
Secondary | number of enthesitic localisations | |||
Secondary | improvement of function (BASFI) | |||
Secondary | improvement of quality of life (SF12) |
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