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

Purpose

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:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

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)

Estimated Enrollment:	176
Study Start Date:	December 2010
Estimated Study Completion Date:	September 2013
Estimated 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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481493

Show 39 Study Locations

Sponsors and Collaborators

Biotest

Investigators

Principal Investigator:

Gianfranco Ferraccioli, M.D.

Universita' Cattolica - Divisione di Reumatologia (study site)

More Information

No publications provided

Responsible Party:	Biotest
ClinicalTrials.gov Identifier:	NCT01481493 History of Changes
Other Study ID Numbers:	979, 2010-018485-24
Study First Received:	October 17, 2011
Last Updated:	April 16, 2013
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
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases

Immune System Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013