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Immunogenicity and Safety of TNFa Kinoid in Rheumatoid Arthritis With Secondary Resistance to TNFa Antagonists

NCT01040715 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-09-18

No results posted yet for this study

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

BIOLOGICAL

TNFa Kinoid

TNFa kinoid

BIOLOGICAL

TNF kinoid

IM administration 2 or 3 injections within 28 days

Sponsors & Collaborators

  • Neovacs

    lead INDUSTRY

Principal Investigators

  • Patrick Durez, MD · Cliniques Universitaires St Luc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-10-31
Completion
2013-09-30

Countries

  • Argentina
  • Belgium
  • Bulgaria
  • Chile
  • Croatia
  • France
  • Romania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01040715 on ClinicalTrials.gov