Prednisolone in Active Ankylosing Spondylitis (AS)

• Status: Unknown status
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

1. to investigate whether steroids are effective in ankylosing spondylitis

2. if steroids are effective to describe how quick they work

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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