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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481493
• Other study ID #: 979
• Secondary ID: 2010-018485-24
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2011
• Last updated: February 19, 2015
• Start date: December 2010
• Est. completion date: November 2013

Study information

• Verified date: February 2015
• Source: Biotest
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlGermany: Paul-Ehrlich-InstitutItaly: Ministry of HealthSpain: Agencia Española de Medicamentos y Productos SanitariosPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsHungary: National Institute of PharmacyLatvia: State Agency of Medicines
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: November 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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-a inhibitors (e.g. abatacept, rituximab, tocilizumab, anakinra)

• treatment with any TNF-a inhibitor within 5 elimination half-lives prior baseline and during the study

• Clinical non-response to more than one of TNF-a inhibitor exceeding adequate treatment duration

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• BT061
subcutaneous administration of the monoclonal antibody BT061
• Placebo
subcutaneous injection of placebo

Locations

Country	Name	City	State
Czech Republic	Study Site	Ostrava
Czech Republic	Study Site	Prague
Czech Republic	Study Site	Uherské Hradiste
Czech Republic	Study Site	Zlín
Germany	Study Site (Berlin 1)	Berlin
Germany	Study Site (Berlin 2)	Berlin
Germany	Study Site	Erlangen
Germany	Study Site	Frankfurt
Germany	Study site	München
Hungary	Study Site	Nyíregyháza
Hungary	Study Site	Székesfehérvár
Italy	Study Site	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
Latvia	Study site	Daugavpils
Latvia	Study site	Riga
Poland	Study Site	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
Spain	Study site (Barcelona 1)	Barcelona
Spain	Study site (Barcelona 2)	Barcelona
Spain	Study Site	Bilbao
Spain	Study Site	Madrid
Spain	Study Site (Madrid2)	Madrid
Spain	Study Site	Málaga
Spain	Study Site	Santander

Sponsors (1)

Lead Sponsor	Collaborator
Biotest

Countries where clinical trial is conducted

Czech Republic,  Germany,  Hungary,  Italy,  Latvia,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	efficacy responses other than ACR20, including questionaires, and their dose dependencies	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	No
Secondary	Safety and tolerability of the various dose levels and of placebo	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	Yes
Secondary	Pharmakokinetics (PK)	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	No