Status:
UNKNOWN
Methotrexate in Ankylosing Spondylitis (MTX in AS)
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 spo...
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 patien...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- 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
- Exclusion criteria:
- 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
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00243750
Start Date
September 1 2003
End Date
November 1 2005
Last Update
December 9 2005
Active Locations (1)
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1
Charité Campus Benjamin-Franklin, Rheumatology
Berlin, Germany, 12200