Status:
COMPLETED
Dose-finding of Multiple Dose of BT061 in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable Methotrexate (MTX)
Lead Sponsor:
Biotest
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The study is conducted in order to find out if repeated doses of the monoclonal (artificially manufactured) antibody BT061 can help arthritis patients whose disease does not sufficiently respond to a ...
Detailed Description
Patients showing active rheumatoid arthritis according to ACR criteria despite at least 6 months of treatment with methotrexate fulfilling all other inclusion criteria including written informed conse...
Eligibility Criteria
Inclusion
- Patients with active Rheumatoid Arthritis (RA) according to 1987 revised ACR criteria with functional class II-III
- Disease activity at screening and baseline (more than 6 swollen joint count; more than 6 tender joint count; elevat. of CRP or ESR)
- Duration of RA more than 12 month
- History of at least one disease-modifying anti-rheumatic drug (DMARD) with an inadequate response despite more than 3 month of treatment
- MTX treatment at least 6 month with a stable dose at least 15mg MTX
- Patients could continue at more than daily 7,5mg of prednisone or equivalent stable dose at least 6 weeks prior baseline
- Written Informed Consent
Exclusion
- Treatment with traditional DMARDs apart from MTX 12 weeks prior to baseline and DMARD leflunomide 24 weeks
- Treatment with any biologics other than TNF-α inhibitors (e.g. abatacept, rituximab, tocilizumab, anakinra)
- treatment with any TNF-α inhibitor within 5 elimination half-lives prior baseline and during the study
- Clinical non-response to more than one of TNF-α inhibitor exceeding adequate treatment duration
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT01481493
Start Date
December 1 2010
End Date
November 1 2013
Last Update
February 20 2015
Active Locations (39)
Enter a location and click search to find clinical trials sorted by distance.
1
Study Site
Ostrava, Czechia
2
Study Site
Prague, Czechia
3
Study Site
Uherské Hradiste, Czechia
4
Study Site
Zlín, Czechia