Methotrexate in Ankylosing Spondylitis (MTX in AS)

• Status: Unknown status
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Methotrexate

Criteria

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