Prednisolone in Active Ankylosing Spondylitis (AS) - Full Text View

Sponsor:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00244166

Purpose

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

Condition	Intervention	Phase
Ankylosing Spondylitis	Drug: prednisolone	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Threecenter Placebo Controlled Three Arm Trial in Patients With Active Ankylosing Spondylitis With Prednisolone

Resource links provided by NLM:

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

50% improvement of BASDAI after 14 days of treatment

Secondary Outcome Measures:

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)

Estimated Enrollment:	75
Study Start Date:	May 2002
Estimated Study Completion Date:	August 2008

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ankylosing spondylitis according to the modified NY criteria 1984
age between 18 and 70 years
insufficient response to therapy with NSAIDs
BASDAI > 4
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
written informed consent

Exclusion Criteria:

Pregnancy or lactation
current severe infection or during the last 3 months
suspected opportunistic infection during the past 2 months (such as Herpes zoster, cytomegaly-, Pneumocystis carinii-infection), HIV-infection
Malignancies
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
Diabetes mellitus or increased blood glucose test
uncontrolled glaucoma
active immunization during the past 2 weeks or planned for the next 8 weeks
pathologic laboratory test results: creatinine >200 µmol/l, liver enzymes > 2,5 fold, AP >2,5 fold upper normal ranges
significant pathological changes during physical examination
clinical trial participation during the past 30 days before screening
intake of "hard drugs" (such as cocaine, heroin)
therapy with more than 7,5 mg prednisolone, intraarticular steroids during the past 4 weeks before study start
current application for retirement

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244166

Contacts

Contact: Joachim Sieper, Prof.	0049 30 8445 ext 4414	joachim.sieper@charite.de
Contact: Hildrun Haibel, MD	0049 30 8445 ext 4414	hildrun.haibel@charite.de

Locations

Germany
Charité Campus Benjamin-Franklin Rheumatolgy	Recruiting
Berlin, Germany, 12200
Contact: Joachim Sieper, Prof. 0049 30 8445 ext 4414 joachim.sieper@charite.de
Contact: Hildrun Haibel, MD 0049 30 8445 ext 4414 hildrun.haibel@charite.de
Principal Investigator: Joachim Sieper, Prof.
Sub-Investigator: Hildrun Haibel, MD
Sub-Investigator: Henning C Brandt, MD
Sub-Investigator: In-Ho Song, MD
Immanuel Hospital Rheumatology	Recruiting
Berlin, Germany, 14109
Contact: Andreas Krause, Prof. 0049 30 80505 ext 293 a.krause@immanuel.de
Principal Investigator: Andreas Krause, Prof.
Rheumazentrum Ruhrgebiet	Recruiting
Herne, Germany, 44652
Contact: Juergen Braun, Prof. 0049 2325592 ext 131 j.braun@rheumazentrum-ruhrgebiet.de
Contact: Xenofon Baraliakos, MD 0049 2325592 ext 131 xenob@onlinehome.de
Principal Investigator: Juergen Braun, Prof.
Sub-Investigator: Xenofon Baraliakos, MD

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Principal Investigator:

Joachim Sieper, Prof.

Charité Campus Benjamin-Franklin Rheumatology

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00244166 History of Changes
Other Study ID Numbers:	P-01
Study First Received:	October 25, 2005
Last Updated:	September 7, 2006
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:

treatment
ankylosing spondylitis
prednisolone
trial
steroid

Additional relevant MeSH terms:

Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Methylprednisolone acetate
Prednisolone acetate
Prednisolone

Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012