Methotrexate in Ankylosing Spondylitis (MTX in AS)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00243750
• Date of registration: 24/10/2005
• Prospective Registration: No
• Primary sponsor: Charite University, Berlin, Germany
• Public title: Methotrexate in Ankylosing Spondylitis (MTX in AS)
• Scientific title: Open Study for the Evaluation of the Efficacy of Methotrexate 20mg Given Subcutaneously in Patients With Active Ankylosing Spondylitis
• Date of first enrolment: September 2003
• Target sample size: 20
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00243750
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Joachim Sieper, Prof.
• Affiliation: Charité Campus Benjamin-Franklin, Rheumatology

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Methotrexate

Primary Outcome(s)

improvement of disease activity parameters according to ASAS - 20% response

Secondary Outcome(s)

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.

Secondary ID(s)

MTX-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors