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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00244166 |
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Date of registration:
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25/10/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prednisolone in Active Ankylosing Spondylitis (AS)
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Scientific title:
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Threecenter Placebo Controlled Three Arm Trial in Patients With Active Ankylosing Spondylitis With Prednisolone |
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Date of first enrolment:
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May 2002 |
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Target sample size:
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75 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00244166 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Germany
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Contacts
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Name:
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Joachim Sieper, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Charité Campus Benjamin-Franklin Rheumatology |
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Name:
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Joachim Sieper, Prof. |
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Address:
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Telephone:
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0049 30 8445 |
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Email:
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joachim.sieper@charite.de |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Drug: prednisolone
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Primary Outcome(s)
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50% improvement of BASDAI after 14 days of treatment
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Secondary Outcome(s)
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number of enthesitic localisations
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Decrease of CRP/ BSG
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improvement of quality of life (SF12)
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improvement of function (BASFI)
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Improvement of pain on a VAS 0 - 10
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Number of swollen/tender joints
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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