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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00243750
Other study ID # MTX-01
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received October 24, 2005
Last updated December 8, 2005
Start date September 2003
Est. completion date November 2005

Study information

Verified date August 2003
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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


Description:

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Study Design

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


Intervention

Drug:
Methotrexate


Locations

Country Name City State
Germany Charité Campus Benjamin-Franklin, Rheumatology Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary improvement of disease activity parameters according to ASAS - 20% response
Secondary 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.
See also
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