Clinical trial NCT01481493: Dose-finding of Multiple Dose of BT061 in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable Methotrexate (MTX)
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Dose-finding Study in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable MTX Doses to Investigate Efficacy and Safety of SC BT061
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
Lead sponsor: Biotest
Sponsor class: INDUSTRY
First posted: 2011-11-29
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 treatment with methotrexate (MTX).

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 consent and none of the exclusion criteria (see below) have the opportunity to be randomised to either treatment with BT061 or placebo, both given subcutaneously in a double-blind set-up.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: dose-response information
timeFrame: ACR20 response at week 13 (1 week after last dose of study drug)
Secondary outcomes:
measure: efficacy responses other than ACR20, including questionaires, and their dose dependencies
timeFrame: weekly assessment of ACR arthritis status during the 12 weeks' treatment course, then repeatedly within 1 to12 weeks after the last dose of study drug
measure: Safety and tolerability of the various dose levels and of placebo
timeFrame: weekly assessment of physical status, safety labs, adverse events during the 12 weeks' treatment course, then repeatedly within 1 to12 weeks after the last dose of study drug
measure: Pharmakokinetics (PK)
timeFrame: weekly blood sampling during the 12 weeks' treatment course, then repeatedly within 1 to12 weeks after the last dose of study drug
Other outcomes:
Locations:
city: Ostrava
country: Czech Republic
facility: Study Site
city: Prague
country: Czech Republic
facility: Study Site
city: Uherské Hradiste
country: Czech Republic
facility: Study Site
city: Zlín
country: Czech Republic
facility: Study Site
city: Berlin
country: Germany
facility: Study Site (Berlin 1)
city: Berlin
country: Germany
facility: Study Site (Berlin 2)
city: Erlangen
country: Germany
facility: Study Site
city: Frankfurt
country: Germany
facility: Study Site
city: München
country: Germany
facility: Study site
city: Nyíregyháza
country: Hungary
facility: Study Site
city: Székesfehérvár
country: Hungary
facility: Study Site
city: Bari
country: Italy
facility: Study Site
city: Cagliari
country: Italy
facility: Study Site
city: Chieti
country: Italy
facility: Study Site
city: Florence
country: Italy
facility: Study Site
city: Genova
country: Italy
facility: Study Site
city: Milano
country: Italy
facility: Study site
city: Padova
country: Italy
facility: Study site
city: Palermo
country: Italy
facility: Study Site
city: Daugavpils
country: Latvia
facility: Study site
city: Riga
country: Latvia
facility: Study site
city: Bialystok
country: Poland
facility: Study Site (Bialystok 2)
city: Bialystok
country: Poland
facility: Study Site
city: Bydgoszcz
country: Poland
facility: Study Site
city: Elblag
country: Poland
facility: Study Site
city: Konskie
country: Poland
facility: Study site
city: Krakow
country: Poland
facility: Study Site
city: Lublin
country: Poland
facility: Study Site
city: Poznan
country: Poland
facility: Study Site
city: Torun
country: Poland
facility: Study Site
city: Warsaw
country: Poland
facility: Study site
city: Wroclaw
country: Poland
facility: Study Site
city: Barcelona
country: Spain
facility: Study site (Barcelona 1)
city: Barcelona
country: Spain
facility: Study site (Barcelona 2)
city: Bilbao
country: Spain
facility: Study Site
city: Madrid
country: Spain
facility: Study Site (Madrid2)
city: Madrid
country: Spain
facility: Study Site
city: Málaga
country: Spain
facility: Study Site
city: Santander
country: Spain
facility: Study Site
Study officials:
affiliation: Institute of Rheumatology, Na Slupi 4, 128 50 Praha 2, Czech Republic
name: Jiří Vencovský, MD
role: STUDY_CHAIR
References: