Overview

Comparative Study of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate

Status:
Active, not recruiting

Trial end date:
2021-06-01

Target enrollment:

Participant gender:

Summary

This is a Phase 3, multicenter, multinational, randomized, double-blind, parallel-group, active-control study to compare efficacy, safety, immunogenicity, and PK of BAT1806 compared with RoActemra in subjects with RA that is inadequately controlled by MTX. The study is composed of a ≤ 28-day screening period, a 24-week initial treatment period (TP1), a 24 week secondary treatment period (TP2), and an extra 4-week follow-up period.

Phase:

Phase 3

Details

Lead Sponsor:

Bio-Thera Solutions

Treatments:

Methotrexate