Study to Investigate the Safety and Efficacy of Tregalizumab in Subjects (MTX-IR) With Active Rheumatoid Arthritis

Summary

The purpose of this study is to determine the efficacy and safety of three different Tregalizumab doses in combination with Methotrexate (MTX) in subjects who have active rheumatoid arthritis and an inadequate response to MTX alone. The overall study duration is 24 weeks followed by a 24 week extension phase.

Timeline

Start

2013-10

Primary completion

2015-07

Completion

2015-07

Outcome

Missed primary endpoint

Stopped: “Lack of efficacy”

paper At week 12, ACR20 response rates were not statistically significantly different between placebo and any of the tregalizumab doses. PMID 29343509 ↗

Publications

• van Vollenhoven RF, Keystone EC, Strand V, Pacheco-Tena C, Vencovsky J, Behrens F, Racewicz A, Zipp D, Rharbaoui F, Wolter R, Knierim L, Schmeidl R, Zhou X, Aigner S, Dalken B, Wartenberg-Demand A; TREAT2b study team. Efficacy and safety of tregalizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase IIb, randomised, placebo-controlled trial. Ann Rheum Dis. 2018 Apr;77(4):495-499. doi: 10.1136/annrheumdis-2017-212478. Epub 2018 Jan 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tregalizumab	Monoclonal antibody	25 mg	Subcutaneous
Subject	Tregalizumab	Monoclonal antibody	100 mg	Subcutaneous
Subject	Tregalizumab	Monoclonal antibody	200 mg	Subcutaneous

Indications