NCT01911234

Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs' TNF-Kinoid in Adult Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Neovacs · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	TNF-Kinoid	IM administration
OTHER	Placebo	IM administration

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-07-30
• Last updated: 2019-03-22

Locations

31 sites across 10 countries: Belgium, Georgia, Hungary, Lebanon, Moldova, North Macedonia, Poland, Russia, Serbia, Ukraine