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

This study has been completed.
Information provided by (Responsible Party):
Biotest Identifier:
First received: October 17, 2011
Last updated: February 19, 2015
Last verified: February 2015
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).

Condition Intervention Phase
Rheumatoid Arthritis
Biological: BT061
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Biotest:

Primary Outcome Measures:
  • dose-response information [ Time Frame: ACR20 response at week 13 (1 week after last dose of study drug) ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    ACR50, ACR70, ESR, DAS28, CRP, HAQs, FACIT, RF, Hb,

  • 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 ] [ Designated as safety issue: Yes ]
    Physical examinations Vital Signs, Safety Lab, assessment of adverse events, tolerability

  • 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 ] [ Designated as safety issue: No ]
    BT061 plasma levels, AUC, time to elimination, accumulation after multiple doses, time course of related hematological parameters (e.g. WBC count)

Enrollment: 127
Study Start Date: December 2010
Study Completion Date: November 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Treatment
BT061 monoclonal antibody (subcutaneous)
Biological: BT061
subcutaneous administration of the monoclonal antibody BT061
Other Name: immune-modulatory antibody BT061
Placebo Comparator: Placebo
subcutaneous injection of placebo
Biological: Placebo
subcutaneous injection of placebo
Other Name: end formulation buffer without active ingredient

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.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01481493

  Show 39 Study Locations
Sponsors and Collaborators
Study Chair: Jiří Vencovský, MD Institute of Rheumatology, Na Slupi 4, 128 50 Praha 2, Czech Republic
  More Information

Responsible Party: Biotest Identifier: NCT01481493     History of Changes
Other Study ID Numbers: 979  2010-018485-24 
Study First Received: October 17, 2011
Last Updated: February 19, 2015
Health Authority: Czech Republic: State Institute for Drug Control
Germany: Paul-Ehrlich-Institut
Italy: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Hungary: National Institute of Pharmacy
Latvia: State Agency of Medicines

Keywords provided by Biotest:
rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on May 23, 2016