Dose-finding of Multiple Dose of BT061 in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable Methotrexate (MTX)
NCT ID: NCT01481493
Last Updated: 2015-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
127 participants
INTERVENTIONAL
2010-12-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active Treatment
BT061 monoclonal antibody (subcutaneous)
BT061
subcutaneous administration of the monoclonal antibody BT061
Placebo
subcutaneous injection of placebo
Placebo
subcutaneous injection of placebo
Interventions
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BT061
subcutaneous administration of the monoclonal antibody BT061
Placebo
subcutaneous injection of placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Biotest
INDUSTRY
Responsible Party
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Principal Investigators
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Jiří Vencovský, MD
Role: STUDY_CHAIR
Institute of Rheumatology, Na Slupi 4, 128 50 Praha 2, Czech Republic
Locations
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Study Site
Ostrava, , Czechia
Study Site
Prague, , Czechia
Study Site
Uherské Hradiste, , Czechia
Study Site
Zlín, , Czechia
Study Site (Berlin 1)
Berlin, , Germany
Study Site (Berlin 2)
Berlin, , Germany
Study Site
Erlangen, , Germany
Study Site
Frankfurt, , Germany
Study site
München, , Germany
Study Site
Nyíregyháza, , Hungary
Study Site
Székesfehérvár, , Hungary
Study Site
Bari, , Italy
Study Site
Cagliari, , Italy
Study Site
Chieti, , Italy
Study Site
Florence, , Italy
Study Site
Genova, , Italy
Study site
Milan, , Italy
Study site
Padua, , Italy
Study Site
Palermo, , Italy
Study site
Daugavpils, , Latvia
Study site
Riga, , Latvia
Study Site (Bialystok 2)
Bialystok, , Poland
Study Site
Bialystok, , Poland
Study Site
Bydgoszcz, , Poland
Study Site
Elblag, , Poland
Study site
Gmina Końskie, , Poland
Study Site
Krakow, , Poland
Study Site
Lublin, , Poland
Study Site
Poznan, , Poland
Study Site
Torun, , Poland
Study site
Warsaw, , Poland
Study Site
Wroclaw, , Poland
Study site (Barcelona 1)
Barcelona, , Spain
Study site (Barcelona 2)
Barcelona, , Spain
Study Site
Bilbao, , Spain
Study Site (Madrid2)
Madrid, , Spain
Study Site
Madrid, , Spain
Study Site
Málaga, , Spain
Study Site
Santander, , Spain
Countries
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Other Identifiers
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2010-018485-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
979
Identifier Type: -
Identifier Source: org_study_id
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