Ankylosing SpondylitisPhase 2/3NCT00244166
Prednisolone in Active Ankylosing Spondylitis (AS)
A Phase 2/3 study testing prednisolone in people with Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 3 sites in Germany.
Trial summary
1. to investigate whether steroids are effective in ankylosing spondylitis 2. if steroids are effective to describe how quick they work Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- prednisolone
- How many people
- 75 participants
- Where
- 3 sitesGermany
- Study dates
- May 2002to Aug 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Recruiting
Charité Campus Benjamin-Franklin Rheumatolgy
Berlin, 12200
Joachim Sieper, Prof., 0049 30 8445 ext. 4414, joachim.sieper@charite.de
Hildrun Haibel, MD, 0049 30 8445 ext. 4414, hildrun.haibel@charite.de
- Recruiting
Immanuel Hospital Rheumatology
Berlin, 14109
Andreas Krause, Prof., 0049 30 80505 ext. 293, a.krause@immanuel.de
Andreas Krause, Prof.
- Recruiting
Rheumazentrum Ruhrgebiet
Herne, 44652
Juergen Braun, Prof., 0049 2325592 ext. 131, j.braun@rheumazentrum-ruhrgebiet.de
Xenofon Baraliakos, MD, 0049 2325592 ext. 131, xenob@onlinehome.de
About this study
Official title: Threecenter Placebo Controlled Three Arm Trial in Patients With Active Ankylosing Spondylitis With Prednisolone
- to investigate whether steroids are effective in ankylosing spondylitis
- if steroids are effective to describe how quick they work
Read the 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.
- Conditions
- Ankylosing Spondylitis
- Being tested
- prednisolone
- Keywords
- treatment, ankylosing spondylitis, prednisolone, trial, steroid
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisoloneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
50% improvement of BASDAI after 14 days of treatment
Secondary outcomes (6)
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2005 (estimated)
- Study startMay 2002
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Joachim Sieper, Prof., Principal investigator, Charité Campus Benjamin-Franklin Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244166
- Sponsor's protocol ID
- P-01
- Status last verified
- Sep 2006
- First submitted
- 25 Oct 2005
- Last updated
- 11 Sep 2006
- Results posted
- No
Publications
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.
PubMed 23625982
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Threecenter Placebo Controlled Three Arm Trial in Patients With Active Ankylosing Spondylitis With Prednisolone
- ClinicalTrials.gov ID
- NCT00244166
- Acronym / sponsor ID
- P-01
- Conditions
- Ankylosing Spondylitis
- Keywords
- treatment, ankylosing spondylitis, prednisolone, trial, steroid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- May 2002
- Study completion
- Aug 2008
- First posted
- 26 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- to investigate whether steroids are effective in ankylosing spondylitis
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prednisolone | Drug | – |
Primary outcome
50% improvement of BASDAI after 14 days of treatment
6 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2006.
- Derived from this study: PubMed 23625982Haibel 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Sieper, Prof. principal investigator
Charité Campus Benjamin-Franklin Rheumatology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing prednisolone in people with Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joachim Sieper, Prof. (0049 30 8445 ext. 4414, joachim.sieper@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
50% improvement of BASDAI after 14 days of treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00244166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2006.