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Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis

NCT01911234 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2019-03-22

No results posted yet for this study

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

Interventions

BIOLOGICAL

TNF-Kinoid

IM administration

OTHER

Placebo

IM administration

Sponsors & Collaborators

  • Neovacs

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Belgium
  • Georgia
  • Hungary
  • Lebanon
  • Moldova
  • North Macedonia
  • Poland
  • Russia
  • Serbia
  • Ukraine

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 NCT01911234 on ClinicalTrials.gov