drugset / Trial / NCT01911234

Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis

NCT01911234 ↗

Phase 2 Completed 143 enrolled Neovacs
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The safety and immunogenicity of the TNF-Kinoid (TNF-K) have been evaluated in a phase II clinical study conducted in subjects with Rheumatoid arthritis. Preliminary results of clinical efficacy are promising. The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with Rheumatoid arthritis in whom treatment with methotrexate is not working anymore. Subjects who have never been treated with anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.

Timeline

Start
2013-09
Primary completion
2014-09
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject TNF Kinoid Unknown — Intramuscular

Indications