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Prednisolone in Active Ankylosing Spondylitis (AS)

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

Tracking Information
First Submitted Date  ICMJE October 25, 2005
First Posted Date  ICMJE October 26, 2005
Last Update Posted Date September 11, 2006
Study Start Date  ICMJE May 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2006)
50% improvement of BASDAI after 14 days of treatment
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2005)
50% improvement of BASDAI after 14 days of treatement
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prednisolone in Active Ankylosing Spondylitis (AS)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Ankylosing Spondylitis
Intervention  ICMJE Drug: prednisolone
Study Arms  ICMJE 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: October 25, 2005)
75
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00244166
Other Study ID Numbers  ICMJE P-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joachim Sieper, Prof. Charité Campus Benjamin-Franklin Rheumatology
PRS Account Charite University, Berlin, Germany
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP