Ankylosing SpondylitisPhase 2NCT00243750
Methotrexate in Ankylosing Spondylitis (MTX in AS)
A Phase 2 study testing Methotrexate in people with Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Assessing the efficacy and tolerability of methotrexate 15mg sc in the first month of treatment- if well tolerated methotrexate 20mg sc in the following 3 months in patients with active anklyosing spondylitis 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?
- Methotrexate
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2003to Nov 2005
- Phase
- Phase 2
- 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
- Definite ankylosing spondylitis according to the New York criteria of 1984.
- Known ankylosing spondylitis according to the modified New York criteria from 1984
- age 18- 70 years
- insufficient therapy with nonsteroidal antirheumatic drugs
- BASDAI > 4
- therapy with DMARD (sulfasalazine, hydroxychloroquine, leflunomide, methotrexate ≤ 10 mg etc.) allowed before study start if discontinued at least 1 month before study start; elimination of leflunomide with colestyramin of coal if necessary. · therapy with biologics (TNF-alpha blocking agents, IL-1-blocking agents etc.) discontinued at least 3 months before study start
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- therapy with steroids ≤ 10 mg at least 4 weeks stable before study start
- patient should be willing to prevent pregnancy by using accepted contraceptive methods until the end of study
- signed informed consent
- patient should be able to administer study drug
- exclusion of pregnancy in female patients with childbearing potential
Who cannot join
- intake of glucocorticosteroids of > 10 mg, therapy with intraarticular steroids within last 4 weeks before study start
- previous therapy with methotrexate > 10 mg
- allergy to methotrexate or parts of medication
- pregnancy/ lactation
- current severe infections, suspicion for opportunistic infections (Herpes zoster, cytomegaly-, pneumocystis carinii-infection) or within the last 4 months , HIV- infection
- malignant disease within the last 5 years
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- severe cardiac, renal, hematologic, endocrine, pulmonary, neurological, gastrointestinal (e.g. gastroesophageal ulcer) or hepatic (viral hepatitis, toxic liver disease etc.) disease, uncontrolled high blood pressure, recurrent thrombosis/ emboly, significant disease in hematopoesis.
- active immunization within last 4 weeks or immunization which is planned for study time
- significant findings in the laboratory: hemoglobin < 8,5 mg/dl, leukopenia < 3,5 /nl, thrombopenia< 100 /nl, creatinine>200 µmol/l, liver enzymes or alkaline phosphate > 1,5-fold over upper limit of normal
- significant pathologic findings in physical examination
- particpation in another clinical trial in last 30 days
- substance abuse, e.g. cocaine, heroine, alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Study for the Evaluation of the Efficacy of Methotrexate 20mg Given Subcutaneously in Patients With Active Ankylosing Spondylitis
Assessing the efficacy and tolerability of methotrexate 15mg sc in the first month of treatment- if well tolerated methotrexate 20mg sc in the following 3 months in patients with active anklyosing spondylitis
Read the detailed description
Ankylosing spondylitis is an inflammatory rheumatic disease mit main affection of the spine. However peripheral joints, entheses and the eyes can also be affected. The rheumatic symptoms of the patients typically show good response to nonsteroidal antirheumatic drugs.
In contrast to rheumatoid arthritis in ankylosing spondylitis there is no evidence that therapy with disease modifying antirheumatic drugs is effective (DMARD). Next to studies with the DMARD sulfasalazine, which seems to be effective mainly in peripheral joint involvement and in which a possible effect in short disease duration also seems to exist for axial involvement, in regards of other DMARDs there are only small studies or case reports.
In terms of methotrexate only small studies with a dosage of 7,5mg - 10 mg - maximally 15mg (perorally in single patients) have been published. In three open studies in 11- 34 patients treated with methotrexate 7,5mg - maximally 15mg perorally over a time duration of 24 weeks until maximally 3 years there a certain effectiveness partly in spinal symptoms, partly in peripheral joint involvement (1, 2, 3). In both double blind controlled studies with 30 and 50 patients respectively with a dosage of 7,5 and 10mg methotrexate respectively no significant effectiveness was shown (4,5). To summarize, in the different studies no effectiveness could be shown clearly.
Therapy with methotrexate in patients with inflammatory rheumatic diseases - especially in rheumatoid arthritis- belongs to standard therapy. In Germany methotrexate is given in about 70% of cases because of its good effectiveness as therapy of first choice. In the treatment of psoriatic arthritis representing a disease which is similar to ankylosing spondylitis in regards to pathogenesis, methotrexate therapy could be established in a dosage of 20mg parenterally and 25mg perorally respectively successfully. Bearing this in mind it is even more surprising that there are no data about methotrexate in this dosages for the treatment of ankylosing spondylitis. According to the German rheumatic register (so-called "rheumatologische Kerndokumentation", PD. Dr. A. Zink, DRFZ, Berlin) already about 20% of patients with ankylosing spondylitis are treated with methotrexate by German rheumatologists. For this reason it is makes sense to perform a study for the treatment of patients with active ankylosing spondylitis with methotrexate in a dosage of 20mg. In the therapy of rheumatoid arthritis a combination of methotrexate and TNFalpha blocking agents leads to an enhancement of effectiveness and reduction of side effects. For this reason the effectivenss of methotrexate in ankylosing spondylitis is also very interesting in regards to a possible combination with TNFalpha blocking agents which have shown to be very successful in the treatment of ankylosing spondyltitis.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Methotrexate
- Keywords
- ankylosing spondylitis, trial, methotrexate
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of disease activity parameters according to ASAS - 20% response
Secondary outcomes (1)
improvement of BASDAI, of pain on a scale from 0-10, reduction of CRP/ ESR (inflammatory serum parameters), reduction of BASFI, BASMI, number of swollen and tender joints, number of enthesitic locations, improvement of life quality.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2005 (estimated)
- Study startSep 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT00243750
- Sponsor's protocol ID
- MTX-01
- Status last verified
- Aug 2003
- First submitted
- 24 Oct 2005
- Last updated
- 9 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Study for the Evaluation of the Efficacy of Methotrexate 20mg Given Subcutaneously in Patients With Active Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT00243750
- Acronym / sponsor ID
- MTX-01
- Conditions
- Ankylosing Spondylitis
- Keywords
- ankylosing spondylitis, trial, methotrexate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Sep 2003
- Study completion
- Nov 2005
- First posted
- 25 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.
Assessing the efficacy and tolerability of methotrexate 15mg sc in the first month of treatment- if well tolerated methotrexate 20mg sc in the following 3 months in patients with active anklyosing spondylitis
Detailed description
Ankylosing spondylitis is an inflammatory rheumatic disease mit main affection of the spine. However peripheral joints, entheses and the eyes can also be affected. The rheumatic symptoms of the patients typically show good response to nonsteroidal antirheumatic drugs.
In contrast to rheumatoid arthritis in ankylosing spondylitis there is no evidence that therapy with disease modifying antirheumatic drugs is effective (DMARD). Next to studies with the DMARD sulfasalazine, which seems to be effective mainly in peripheral joint involvement and in which a possible effect in short disease duration also seems to exist for axial involvement, in regards of other DMARDs there are only small studies or case reports.
In terms of methotrexate only small studies with a dosage of 7,5mg - 10 mg - maximally 15mg (perorally in single patients) have been published. In three open studies in 11- 34 patients treated with methotrexate 7,5mg - maximally 15mg perorally over a time duration of 24 weeks until maximally 3 years there a certain effectiveness partly in spinal symptoms, partly in peripheral joint involvement (1, 2, 3). In both double blind controlled studies with 30 and 50 patients respectively with a dosage of 7,5 and 10mg methotrexate respectively no significant effectiveness was shown (4,5). To summarize, in the different studies no effectiveness could be shown clearly.
Therapy with methotrexate in patients with inflammatory rheumatic diseases - especially in rheumatoid arthritis- belongs to standard therapy. In Germany methotrexate is given in about 70% of cases because of its good effectiveness as therapy of first choice. In the treatment of psoriatic arthritis representing a disease which is similar to ankylosing spondylitis in regards to pathogenesis, methotrexate therapy could be established in a dosage of 20mg parenterally and 25mg perorally respectively successfully. Bearing this in mind it is even more surprising that there are no data about methotrexate in this dosages for the treatment of ankylosing spondylitis. According to the German rheumatic register (so-called "rheumatologische Kerndokumentation", PD. Dr. A. Zink, DRFZ, Berlin) already about 20% of patients with ankylosing spondylitis are treated with methotrexate by German rheumatologists. For this reason it is makes sense to perform a study for the treatment of patients with active ankylosing spondylitis with methotrexate in a dosage of 20mg. In the therapy of rheumatoid arthritis a combination of methotrexate and TNFalpha blocking agents leads to an enhancement of effectiveness and reduction of side effects. For this reason the effectivenss of methotrexate in ankylosing spondylitis is also very interesting in regards to a possible combination with TNFalpha blocking agents which have shown to be very successful in the treatment of ankylosing spondyltitis.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Definite ankylosing spondylitis according to the New York criteria of 1984.
- Known ankylosing spondylitis according to the modified New York criteria from 1984
- age 18- 70 years
- insufficient therapy with nonsteroidal antirheumatic drugs
- BASDAI > 4
Key exclusion criteria (12 listed)
- intake of glucocorticosteroids of > 10 mg, therapy with intraarticular steroids within last 4 weeks before study start
- previous therapy with methotrexate > 10 mg
- allergy to methotrexate or parts of medication
- pregnancy/ lactation
- current severe infections, suspicion for opportunistic infections (Herpes zoster, cytomegaly-, pneumocystis carinii-infection) or within the last 4 months , HIV- infection
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 |
|---|---|---|
| Methotrexate | Drug | – |
Primary outcome
improvement of disease activity parameters according to ASAS - 20% response
1 secondary outcome
improvement of BASDAI, of pain on a scale from 0-10, reduction of CRP/ ESR (inflammatory serum parameters), reduction of BASFI, BASMI, number of swollen and tender joints, number of enthesitic locations, improvement of life quality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2005.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methotrexate in people with Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 1 site 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 11 inclusion and 12 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 9 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of disease activity parameters according to ASAS - 20% response. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2005.