Prednisolone in Active Ankylosing Spondylitis (AS)

Charite University, Berlin, Germany75 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ankylosing Spondylitis

Interventions

prednisoloneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (3)

Charité Campus Benjamin-Franklin Rheumatolgy

Berlin, Germany

RECRUITING

Immanuel Hospital Rheumatology

Berlin, Germany

RECRUITING

Rheumazentrum Ruhrgebiet

Herne, Germany

RECRUITING

Outcomes

Primary Outcomes

50% improvement of BASDAI after 14 days of treatment

Secondary Outcomes

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)

Central Contacts

Joachim Sieper, Prof.

CONTACT

0049 30 8445 joachim.sieper@charite.de

Hildrun Haibel, MD

CONTACT

0049 30 8445 hildrun.haibel@charite.de

Data from ClinicalTrials.gov

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