Prednisolone in Active Ankylosing Spondylitis (AS)

September 7, 2006 updated by: Charite University, Berlin, Germany

Threecenter Placebo Controlled Three Arm Trial in Patients With Active Ankylosing Spondylitis With Prednisolone

  1. to investigate whether steroids are effective in ankylosing spondylitis
  2. if steroids are effective to describe how quick they work

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment

75

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Recruiting
        • Charité Campus Benjamin-Franklin Rheumatolgy
        • Contact:
        • Sub-Investigator:
          • Henning C Brandt, MD
        • Sub-Investigator:
          • Hildrun Haibel, MD
        • Sub-Investigator:
          • In-Ho Song, MD
        • Contact:
        • Principal Investigator:
          • Joachim Sieper, Prof.
      • Berlin, Germany, 14109
        • Recruiting
        • Immanuel Hospital Rheumatology
        • Contact:
        • Principal Investigator:
          • Andreas Krause, Prof.
      • Herne, Germany, 44652
        • Recruiting
        • Rheumazentrum Ruhrgebiet
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juergen Braun, Prof.
        • Sub-Investigator:
          • Xenofon Baraliakos, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
50% improvement of BASDAI after 14 days of treatment

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Study Completion

August 1, 2008

Study Registration Dates

First Submitted

October 25, 2005

First Submitted That Met QC Criteria

October 25, 2005

First Posted (Estimate)

October 26, 2005

Study Record Updates

Last Update Posted (Estimate)

September 11, 2006

Last Update Submitted That Met QC Criteria

September 7, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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