Ankylosing Spondylitis Clinical Trial
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
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training
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