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

NCT01481493 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2015-02-20

No results posted yet for this study

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

Interventions

BIOLOGICAL

BT061

subcutaneous administration of the monoclonal antibody BT061

BIOLOGICAL

Placebo

subcutaneous injection of placebo

Sponsors & Collaborators

  • Biotest

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-08-31
Completion
2013-11-30

Countries

  • Czechia
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01481493 on ClinicalTrials.gov