Trials / Completed
CompletedNCT01040715
Immunogenicity and Safety of TNFa Kinoid in Rheumatoid Arthritis With Secondary Resistance to TNFa Antagonists
A Phase II, Randomized, Double-blind, Controlled Study to Evaluate the Immune Responses, Safety and Clinical Efficacy of Three Doses of Neovacs' TNF-Kinoid in Adult Patients With Rheumatoid Arthritis Who Have Relapsed Despite Anti-TNFα Biological Therapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Neovacs · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this trial is to demonstrate that active immunization with anti-TNFα kinoid (TNF-K) is able to induce polyclonal anti-TNFα antibodies in RA patients who were previously treated with anti-TNFα mAb but have lost susceptibility to therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TNFa Kinoid | TNFa kinoid |
| BIOLOGICAL | TNF kinoid | IM administration 2 or 3 injections within 28 days |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2012-10-01
- Completion
- 2013-09-01
- First posted
- 2009-12-30
- Last updated
- 2014-09-18
Locations
35 sites across 7 countries: Argentina, Belgium, Bulgaria, Chile, Croatia, France, Romania
Source: ClinicalTrials.gov record NCT01040715. Inclusion in this directory is not an endorsement.