Ankylosing Spondylitis Clinical Trial
Official title:
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02685904 -
A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing Spondylitis
|
Phase 3 | |
Completed |
NCT02186873 -
A Study of Golimumab in Participants With Active Ankylosing Spondylitis
|
Phase 3 | |
Completed |
NCT01668004 -
The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012)
|
Phase 4 | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Completed |
NCT01934933 -
Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis
|
Phase 4 | |
Not yet recruiting |
NCT04875299 -
Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients
|
||
Completed |
NCT02758782 -
NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis
|
Phase 4 | |
Completed |
NCT02763111 -
Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis
|
Phase 2 | |
Active, not recruiting |
NCT02687620 -
Does Immunogenicity Have an Influence on the Efficacy of Anti-TNF Therapy in Patients With AS: An Inception Cohort Study
|
||
Completed |
NCT02154425 -
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
|
Phase 1 | |
Completed |
NCT01750528 -
Prevalence and Progression of Periodontitis in Ankylosing Spondylitis
|
N/A | |
Completed |
NCT01463189 -
Web-based Support to Manage Arthritis Pain
|
Phase 2 | |
Completed |
NCT01091675 -
Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to ≥2 NSAIDs
|
Phase 3 | |
Completed |
NCT00844805 -
Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)
|
Phase 3 | |
Recruiting |
NCT00747578 -
Health-Related Quality of Life and Disease-Related Costs: Comparison Between Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus in Taiwan
|
N/A | |
Completed |
NCT01083693 -
Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs
|
N/A | |
Completed |
NCT00715091 -
Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis
|
Phase 4 | |
Not yet recruiting |
NCT00517101 -
Presence of IBD Specific Antibodies (ASCA, ALCA, ACCA, AMCA) in the Sera of Patients With Spondyloarthropathy
|
N/A | |
Completed |
NCT00367211 -
Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.
|
Phase 3 | |
Completed |
NCT00133315 -
TNFalfa Blocking Treatment of Spondylarthropathies
|
Phase 4 |