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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

Study Description
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Brief Summary:
  1. to investigate whether steroids are effective in ankylosing spondylitis
  2. if steroids are effective to describe how quick they work

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: prednisolone Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Threecenter Placebo Controlled Three Arm Trial in Patients With Active Ankylosing Spondylitis With Prednisolone
Study Start Date : May 2002
Study Completion Date : August 2008

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 50% improvement of BASDAI after 14 days of treatment

Secondary Outcome Measures :
  1. Improvement of pain on a VAS 0 - 10
  2. Decrease of CRP/ BSG
  3. Number of swollen/tender joints
  4. number of enthesitic localisations
  5. improvement of function (BASFI)
  6. improvement of quality of life (SF12)

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244166


Contacts
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Contact: Joachim Sieper, Prof. 0049 30 8445 ext 4414 joachim.sieper@charite.de
Contact: Hildrun Haibel, MD 0049 30 8445 ext 4414 hildrun.haibel@charite.de

Locations
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Germany
Charité Campus Benjamin-Franklin Rheumatolgy Recruiting
Berlin, Germany, 12200
Contact: Joachim Sieper, Prof.    0049 30 8445 ext 4414    joachim.sieper@charite.de   
Contact: Hildrun Haibel, MD    0049 30 8445 ext 4414    hildrun.haibel@charite.de   
Principal Investigator: Joachim Sieper, Prof.         
Sub-Investigator: Hildrun Haibel, MD         
Sub-Investigator: Henning C Brandt, MD         
Sub-Investigator: In-Ho Song, MD         
Immanuel Hospital Rheumatology Recruiting
Berlin, Germany, 14109
Contact: Andreas Krause, Prof.    0049 30 80505 ext 293    a.krause@immanuel.de   
Principal Investigator: Andreas Krause, Prof.         
Rheumazentrum Ruhrgebiet Recruiting
Herne, Germany, 44652
Contact: Juergen Braun, Prof.    0049 2325592 ext 131    j.braun@rheumazentrum-ruhrgebiet.de   
Contact: Xenofon Baraliakos, MD    0049 2325592 ext 131    xenob@onlinehome.de   
Principal Investigator: Juergen Braun, Prof.         
Sub-Investigator: Xenofon Baraliakos, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Joachim Sieper, Prof. Charité Campus Benjamin-Franklin Rheumatology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00244166    
Other Study ID Numbers: P-01
First Posted: October 26, 2005    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: September 2006
Keywords provided by Charite University, Berlin, Germany:
treatment
ankylosing spondylitis
prednisolone
trial
steroid
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
 Joint Diseases
Arthritis
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents