Methotrexate in Ankylosing Spondylitis (MTX in AS)

NCT00243750 | Unknown Phase 2

• 1 other identifier: MTX-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 spondylitis

Conditions

Ankylosing Spondylitis

Keywords

ankylosing spondylitis; trial; methotrexate

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Methotrexate DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Campus Benjamin-Franklin, Rheumatology

Berlin, 12200, Germany

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joachim Sieper, Prof.

  Charité Campus Benjamin-Franklin, Rheumatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: ECT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 24, 2005
• First Posted: October 25, 2005
• Study Start: September 1, 2003
• Study Completion: November 1, 2005
• Last Updated: December 9, 2005

Record last verified: 2003-08

Locations

DE (1)