NCT01481493

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Biotest · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	BT061	subcutaneous administration of the monoclonal antibody BT061
BIOLOGICAL	Placebo	subcutaneous injection of placebo

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-08-01
• Completion: 2013-11-01
• First posted: 2011-11-29
• Last updated: 2015-02-20

Locations

39 sites across 7 countries: Czechia, Germany, Hungary, Italy, Latvia, Poland, Spain