drugset / Trial / NCT01990157

Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis

NCT01990157 ↗

Phase 1/2 Completed 18 enrolled Theramab LLC
NaSingle-groupOpen-labelTreatment

Summary

This study is in two stages: Stage 1 purpose is to assess safety, tolerability, and efficacy of multiple TAB08 doses in patients with active Rheumatoid Arthritis in which methotrexate (MTX) treatment is not enough effective. Stage 2 purpose is to assess efficacy parameters (ACR criteria) of at least one selected TAB08 dose in extended patient population with active Rheumatoid Arthritis in which methotrexate (MTX) treatment with at least 10 mg/week is not enough effective.

Timeline

Start
2013-11
Primary completion
2015-12
Completion
2017-02

Drugs

EvaluationDrugModalityDoseRoute
Subject TGN-1412 Monoclonal antibody — Intravenous

Indications