Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244166
Status:
UNKNOWN
Last Update Posted:
2006-09-11
First Post:
2005-10-25
Brief Title:
Prednisolone in Active Ankylosing Spondylitis AS
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Threecenter Placebo Controlled Three Arm Trial in Patients With Active Ankylosing Spondylitis With Prednisolone
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 to investigate whether steroids are effective in ankylosing spondylitis
2 if steroids are effective to describe how quick they work
2 if steroids are effective to describe how quick they work
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None