Status:
UNKNOWN
Prednisolone in Active Ankylosing Spondylitis (AS)
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
1. to investigate whether steroids are effective in ankylosing spondylitis 2. if steroids are effective to describe how quick they work
Detailed Description
Treatment of inflammatory rheumatic conditions with glucocorticosteroids is a mainstay in therapy. In rheumatic diseases such as rheumatoid arthritis, systemic lupus erythematodes and polymyalgia rheu...
Eligibility Criteria
Inclusion
- ankylosing spondylitis according to the modified NY criteria 1984
- age between 18 and 70 years
- insufficient response to therapy with NSAIDs
- BASDAI \> 4
- 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
- written informed consent
Exclusion
- Pregnancy or lactation
- current severe infection or during the last 3 months
- suspected opportunistic infection during the past 2 months (such as Herpes zoster, cytomegaly-, Pneumocystis carinii-infection), HIV-infection
- Malignancies
- 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
- Diabetes mellitus or increased blood glucose test
- uncontrolled glaucoma
- active immunization during the past 2 weeks or planned for the next 8 weeks
- pathologic laboratory test results: creatinine \>200 µmol/l, liver enzymes \> 2,5 fold, AP \>2,5 fold upper normal ranges
- significant pathological changes during physical examination
- clinical trial participation during the past 30 days before screening
- intake of "hard drugs" (such as cocaine, heroin)
- therapy with more than 7,5 mg prednisolone, intraarticular steroids during the past 4 weeks before study start
- current application for retirement
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2008
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00244166
Start Date
May 1 2002
End Date
August 1 2008
Last Update
September 11 2006
Active Locations (3)
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1
Charité Campus Benjamin-Franklin Rheumatolgy
Berlin, Germany, 12200
2
Immanuel Hospital Rheumatology
Berlin, Germany, 14109
3
Rheumazentrum Ruhrgebiet
Herne, Germany, 44652