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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prednisolone | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 50% improvement of BASDAI after 14 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of pain on a VAS 0 - 10 | ||
| Decrease of CRP/ BSG | ||
| Number of swollen/tender joints |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joachim Sieper, Prof. | Contact | 0049 30 8445 | 4414 | joachim.sieper@charite.de |
| Hildrun Haibel, MD | Contact | 0049 30 8445 | 4414 | hildrun.haibel@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Joachim Sieper, Prof. | Charité Campus Benjamin-Franklin Rheumatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Campus Benjamin-Franklin Rheumatolgy | Recruiting | Berlin | 12200 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23625982 | Derived | 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. |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| number of enthesitic localisations |
| improvement of function (BASFI) |
| improvement of quality of life (SF12) |
| Immanuel Hospital Rheumatology | Recruiting | Berlin | 14109 | Germany |
|
| Rheumazentrum Ruhrgebiet | Recruiting | Herne | 44652 | Germany |
|
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |