Prednisolone in Active Ankylosing Spondylitis (AS)

• ClinicalTrials.gov Identifier: NCT00244166
• Recruitment Status: Unknown
• First Posted: October 26, 2005
• Last Update Posted: September 11, 2006
• Sponsor: Charite University, Berlin, Germany
• Information provided by: Charite University, Berlin, Germany

Tracking Information

• First Submitted Date: October 25, 2005
• First Posted Date: October 26, 2005
• Last Update Posted Date: September 11, 2006
• Study Start Date: May 2002
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: September 7, 2006): 50% improvement of BASDAI after 14 days of treatment
• Original Primary Outcome Measures (submitted: October 25, 2005): 50% improvement of BASDAI after 14 days of treatement

Current Secondary Outcome Measures (submitted: October 25, 2005)

• Improvement of pain on a VAS 0 - 10
• Decrease of CRP/ BSG
• Number of swollen/tender joints
• number of enthesitic localisations
• improvement of function (BASFI)
• improvement of quality of life (SF12)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prednisolone in Active Ankylosing Spondylitis (AS)
• Official Title: Threecenter Placebo Controlled Three Arm Trial in Patients With Active Ankylosing Spondylitis With Prednisolone

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 rheumatica glucocorticosteroids show a prompt effect in regards of musculoskeletal symptoms.

Ankylosing spondylitis (AS) is an inflammatory rheumatic disease mainly affecting the spine. However peripheral joints, entheses and the eyes can also be affected. The rheumatic symptoms of AS patients typically show good and quick response to treatment with nonsteroidal antirheumatic drugs (NSAIDs). In contrast to rheumatoid arthritis there is no proof that disease modifying antirheumatic drugs (DMARDs) work. Surprisingly there is the common opinion, mainly based on personal experiences, that glucocorticosteroids in spondylarthropathies do not work. However there are no reliable clinical studies answering this question. In the literature of the last 20 years there are only single reports about the treatment of AS with highly dosed methylprednisolone (intravenous pulse therapy). The pretended lack of effectiveness of glucocorticosteroids surprises moreover as NSAIDs are very effective as well as local intraarticular steroid injections including the sacroiliac joints. In addition with magnetic resonance imaging acute inflammatory lesions can be visualized especially as subchondral edema in bone marrow. Besides about 70% of patients with active AS show elevated inflammatory serum markers such as erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Moreover we could recently that a treatment of AS patients with the monoclonal antibody against TNFa (Infliximab) is highly effective. TNFa is a very important pro-inflammatory cytokine (Brandt et al 2000).

For all these reasons it is very important and urgent to perform a study for the treatment of active AS with glucocorticosteroids using evaluated measuring instruments.

• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Ankylosing Spondylitis
• Intervention: Drug: prednisolone
• Study Arms: Not Provided
• Publications *: Haibel H, Fendler C, Listing J, Callhoff J, Braun J, Sieper J. Efficacy of oral prednisolone in active ankylosing spondylitis: results of a double-blind, randomised, placebo-controlled short-term trial. Ann Rheum Dis. 2014 Jan;73(1):243-6. doi: 10.1136/annrheumdis-2012-203055. Epub 2013 Apr 26.

Recruitment Information

• Recruitment Status: Unknown status
• Enrollment (submitted: October 25, 2005): 75
• Original Enrollment: Same as current
• Study Completion Date: August 2008
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00244166
• Other Study ID Numbers: P-01
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Charite University, Berlin, Germany
• Collaborators: Not Provided

Investigators

• Principal Investigator: Joachim Sieper, Prof.; Charité Campus Benjamin-Franklin Rheumatology

• PRS Account: Charite University, Berlin, Germany
• Verification Date: September 2006