Prednisolone in Active Ankylosing Spondylitis (AS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00244166
First received: October 25, 2005
Last updated: September 7, 2006
Last verified: September 2006
  Purpose
  1. to investigate whether steroids are effective in ankylosing spondylitis
  2. if steroids are effective to describe how quick they work

Condition Intervention Phase
Ankylosing Spondylitis
Drug: prednisolone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Threecenter Placebo Controlled Three Arm Trial in Patients With Active Ankylosing Spondylitis With Prednisolone

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 50% improvement of BASDAI after 14 days of treatment

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 75
Study Start Date: May 2002
Estimated Study Completion Date: August 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244166

Contacts
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
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
Principal Investigator: Joachim Sieper, Prof. Charité Campus Benjamin-Franklin Rheumatology
  More Information

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00244166     History of Changes
Other Study ID Numbers: P-01
Study First Received: October 25, 2005
Last Updated: September 7, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
treatment
ankylosing spondylitis
prednisolone
trial
steroid

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Spondylitis
Ankylosis
Arthritis
Bone Diseases
Bone Diseases, Infectious
Infection
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents

ClinicalTrials.gov processed this record on October 22, 2014