Dose-finding of Multiple Dose of BT061 in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable Methotrexate (MTX)

February 19, 2015 updated by: Biotest

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Ostrava, Czech Republic
        • Study Site
      • Prague, Czech Republic
        • Study Site
      • Uherské Hradiste, Czech Republic
        • Study Site
      • Zlín, Czech Republic
        • Study Site
  • Germany
      • Berlin, Germany
        • Study Site (Berlin 1)
      • Berlin, Germany
        • Study Site (Berlin 2)
      • Erlangen, Germany
        • Study Site
      • Frankfurt, Germany
        • Study Site
      • München, Germany
        • Study Site
  • Hungary
      • Nyíregyháza, Hungary
        • Study Site
      • Székesfehérvár, Hungary
        • Study Site
  • Italy
      • Bari, Italy
        • Study Site
      • Cagliari, Italy
        • Study Site
      • Chieti, Italy
        • Study Site
      • Florence, Italy
        • Study Site
      • Genova, Italy
        • Study Site
      • Milano, Italy
        • Study Site
      • Padova, Italy
        • Study Site
      • Palermo, Italy
        • Study Site
  • Latvia
      • Daugavpils, Latvia
        • Study Site
      • Riga, Latvia
        • Study Site
  • Poland
      • Bialystok, Poland
        • Study Site (Bialystok 2)
      • Bialystok, Poland
        • Study Site
      • Bydgoszcz, Poland
        • Study Site
      • Elblag, Poland
        • Study Site
      • Konskie, 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
  • Spain
      • Barcelona, Spain
        • Study site (Barcelona 1)
      • Barcelona, Spain
        • Study site (Barcelona 2)
      • Bilbao, Spain
        • Study Site
      • Madrid, Spain
        • Study Site (Madrid2)
      • Madrid, Spain
        • Study Site
      • Málaga, Spain
        • Study Site
      • Santander, Spain
        • Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Treatment
BT061 monoclonal antibody (subcutaneous)
Biological: BT061
subcutaneous administration of the monoclonal antibody BT061
Other Names:
  • immune-modulatory antibody BT061
Placebo Comparator: Placebo
subcutaneous injection of placebo
Biological: Placebo
subcutaneous injection of placebo
Other Names:
  • end formulation buffer without active ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dose-response information
Time Frame: ACR20 response at week 13 (1 week after last dose of study drug)
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)
ACR20 response at week 13 (1 week after last dose of study drug)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy responses other than ACR20, including questionaires, and their dose dependencies
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
ACR50, ACR70, ESR, DAS28, CRP, HAQs, FACIT, RF, Hb,
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
Safety and tolerability of the various dose levels and of placebo
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
Physical examinations Vital Signs, Safety Lab, assessment of adverse events, tolerability
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
Pharmakokinetics (PK)
Time Frame: weekly blood sampling during the 12 weeks' treatment course, then repeatedly within 1 to12 weeks after the last dose of study drug
BT061 plasma levels, AUC, time to elimination, accumulation after multiple doses, time course of related hematological parameters (e.g. WBC count)
weekly blood sampling during the 12 weeks' treatment course, then repeatedly within 1 to12 weeks after the last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotest

Investigators

  • Study Chair: Jiří Vencovský, MD, Institute of Rheumatology, Na Slupi 4, 128 50 Praha 2, Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

October 17, 2011

First Submitted That Met QC Criteria

November 25, 2011

First Posted (Estimate)

November 29, 2011

Study Record Updates

Last Update Posted (Estimate)

February 20, 2015

Last Update Submitted That Met QC Criteria

February 19, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 979
  • 2010-018485-24 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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