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

NCT01481493 | Completed Phase 2 DMC

• 2 other identifiers: 9792010-018485-24
• Study Type: interventional
• Target: 127
• Locations: 7 countries
• Sites: 39

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).

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• 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)

  ACR20 response at week 13 (1 week after last dose of study drug)

Secondary Outcomes (3)

• efficacy responses other than ACR20, including questionaires, and their dose dependencies

  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

  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)

  weekly blood sampling during the 12 weeks' treatment course, then repeatedly within 1 to12 weeks after the last dose of study drug

Study Arms (2)

Active Treatment

EXPERIMENTAL

BT061 monoclonal antibody (subcutaneous)

Biological: BT061

Placebo

PLACEBO COMPARATOR

subcutaneous injection of placebo

Biological: Placebo

Interventions

BT061 BIOLOGICAL

subcutaneous administration of the monoclonal antibody BT061

Also known as: immune-modulatory antibody BT061

Active Treatment

Placebo BIOLOGICAL

subcutaneous injection of placebo

Also known as: end formulation buffer without active ingredient

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotest: lead

Study Sites (39)

Study Site

Ostrava, Czechia

Location

Study Site

Prague, Czechia

Location

Study Site

Uherské Hradiste, Czechia

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Study Site

Zlín, Czechia

Location

Study Site (Berlin 1)

Berlin, Germany

Location

Study Site (Berlin 2)

Berlin, Germany

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Study Site

Erlangen, Germany

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Study Site

Frankfurt, Germany

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München, Germany

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Study Site

Nyíregyháza, Hungary

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Székesfehérvár, Hungary

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Study Site

Bari, Italy

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Cagliari, Italy

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Chieti, Italy

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Florence, Italy

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Genova, Italy

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Milan, Italy

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Padua, Italy

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Palermo, Italy

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Daugavpils, Latvia

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Riga, Latvia

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Study Site (Bialystok 2)

Bialystok, Poland

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Study Site

Bialystok, Poland

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Bydgoszcz, Poland

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Elblag, Poland

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Gmina Końskie, Poland

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Krakow, Poland

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Lublin, Poland

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Poznan, Poland

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Torun, Poland

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Warsaw, Poland

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Study Site

Wroclaw, Poland

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Study site (Barcelona 1)

Barcelona, Spain

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Study site (Barcelona 2)

Barcelona, Spain

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Study Site

Bilbao, Spain

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Study Site (Madrid2)

Madrid, Spain

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Study Site

Madrid, Spain

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Study Site

Málaga, Spain

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Study Site

Santander, Spain

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jiří Vencovský, MD

  Institute of Rheumatology, Na Slupi 4, 128 50 Praha 2, Czech Republic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: November 29, 2011
• Study Start: December 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 20, 2015

Record last verified: 2015-02

Locations

HU (2); CZ (4); IT (8); LA (2); DE (5); ES (7); PL (11)