Back to resultsDose-finding of Multiple Dose of BT061 in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable Methotrexate (MTX)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BT061
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis
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
Sites / Locations
- Study Site
- Study Site
- Study Site
- Study Site
- Study Site (Berlin 1)
- Study Site (Berlin 2)
- Study Site
- Study Site
- Study site
- Study Site
- Study Site
- Study Site
- Study Site
- Study Site
- Study Site
- Study Site
- Study site
- Study site
- Study Site
- Study site
- Study site
- Study Site (Bialystok 2)
- Study Site
- Study Site
- Study Site
- Study site
- Study Site
- Study Site
- Study Site
- Study Site
- Study site
- Study Site
- Study site (Barcelona 1)
- Study site (Barcelona 2)
- Study Site
- Study Site (Madrid2)
- Study Site
- Study Site
- Study Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active Treatment
Placebo
Arm Description
BT061 monoclonal antibody (subcutaneous)
subcutaneous injection of placebo
Outcomes
Primary Outcome Measures
dose-response information
ACR20 response (percentage of patients reaching or exceeding at least a 20% improvement in their arthritis assessment according to the criteria of the American College of Rheumatology)
Secondary Outcome Measures
efficacy responses other than ACR20, including questionaires, and their dose dependencies
ACR50, ACR70, ESR, DAS28, CRP, HAQs, FACIT, RF, Hb,
Safety and tolerability of the various dose levels and of placebo
Physical examinations Vital Signs, Safety Lab, assessment of adverse events, tolerability
Pharmakokinetics (PK)
BT061 plasma levels, AUC, time to elimination, accumulation after multiple doses, time course of related hematological parameters (e.g. WBC count)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01481493
Brief Title
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
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotest
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Treatment
Arm Type
Experimental
Arm Description
BT061 monoclonal antibody (subcutaneous)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
subcutaneous injection of placebo
Intervention Type
Biological
Intervention Name(s)
BT061
Other Intervention Name(s)
immune-modulatory antibody BT061
Intervention Description
subcutaneous administration of the monoclonal antibody BT061
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
end formulation buffer without active ingredient
Intervention Description
subcutaneous injection of placebo
Primary Outcome Measure Information:
Title
dose-response information
Description
ACR20 response (percentage of patients reaching or exceeding at least a 20% improvement in their arthritis assessment according to the criteria of the American College of Rheumatology)
Time Frame
ACR20 response at week 13 (1 week after last dose of study drug)
Secondary Outcome Measure Information:
Title
efficacy responses other than ACR20, including questionaires, and their dose dependencies
Description
ACR50, ACR70, ESR, DAS28, CRP, HAQs, FACIT, RF, Hb,
Time Frame
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
Title
Safety and tolerability of the various dose levels and of placebo
Description
Physical examinations Vital Signs, Safety Lab, assessment of adverse events, tolerability
Time Frame
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
Title
Pharmakokinetics (PK)
Description
BT061 plasma levels, AUC, time to elimination, accumulation after multiple doses, time course of related hematological parameters (e.g. WBC count)
Time Frame
weekly blood sampling during the 12 weeks' treatment course, then repeatedly within 1 to12 weeks after the last dose of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiří Vencovský, MD
Organizational Affiliation
Institute of Rheumatology, Na Slupi 4, 128 50 Praha 2, Czech Republic
Official's Role
Study Chair
Facility Information:
Facility Name
Study Site
City
Ostrava
Country
Czech Republic
Facility Name
Study Site
City
Prague
Country
Czech Republic
Facility Name
Study Site
City
Uherské Hradiste
Country
Czech Republic
Facility Name
Study Site
City
Zlín
Country
Czech Republic
Facility Name
Study Site (Berlin 1)
City
Berlin
Country
Germany
Facility Name
Study Site (Berlin 2)
City
Berlin
Country
Germany
Facility Name
Study Site
City
Erlangen
Country
Germany
Facility Name
Study Site
City
Frankfurt
Country
Germany
Facility Name
Study site
City
München
Country
Germany
Facility Name
Study Site
City
Nyíregyháza
Country
Hungary
Facility Name
Study Site
City
Székesfehérvár
Country
Hungary
Facility Name
Study Site
City
Bari
Country
Italy
Facility Name
Study Site
City
Cagliari
Country
Italy
Facility Name
Study Site
City
Chieti
Country
Italy
Facility Name
Study Site
City
Florence
Country
Italy
Facility Name
Study Site
City
Genova
Country
Italy
Facility Name
Study site
City
Milano
Country
Italy
Facility Name
Study site
City
Padova
Country
Italy
Facility Name
Study Site
City
Palermo
Country
Italy
Facility Name
Study site
City
Daugavpils
Country
Latvia
Facility Name
Study site
City
Riga
Country
Latvia
Facility Name
Study Site (Bialystok 2)
City
Bialystok
Country
Poland
Facility Name
Study Site
City
Bialystok
Country
Poland
Facility Name
Study Site
City
Bydgoszcz
Country
Poland
Facility Name
Study Site
City
Elblag
Country
Poland
Facility Name
Study site
City
Konskie
Country
Poland
Facility Name
Study Site
City
Krakow
Country
Poland
Facility Name
Study Site
City
Lublin
Country
Poland
Facility Name
Study Site
City
Poznan
Country
Poland
Facility Name
Study Site
City
Torun
Country
Poland
Facility Name
Study site
City
Warsaw
Country
Poland
Facility Name
Study Site
City
Wroclaw
Country
Poland
Facility Name
Study site (Barcelona 1)
City
Barcelona
Country
Spain
Facility Name
Study site (Barcelona 2)
City
Barcelona
Country
Spain
Facility Name
Study Site
City
Bilbao
Country
Spain
Facility Name
Study Site (Madrid2)
City
Madrid
Country
Spain
Facility Name
Study Site
City
Madrid
Country
Spain
Facility Name
Study Site
City
Málaga
Country
Spain
Facility Name
Study Site
City
Santander
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Dose-finding of Multiple Dose of BT061 in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable Methotrexate (MTX)
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