MedTrace Logo

Th17 Responses Evaluated in RA Patients on Inhibitors of TNFα

NCT02620189 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2022-09-26

No results posted yet for this study

Summary

Preliminary data suggest that up-regulation of Interleukin -17 (IL-17) and the T-helper 17 (Th17) pathway occurs in rheumatoid arthritis (RA) patients on anti-Tumour Necrosis Factor (TNF) therapy who demonstrated an incomplete clinical response. A deeper understanding of this is required in order to determine whether IL-17 or the Th17 pathway is a valid target for intervention in this population to improve response outcome.

The study objective is to observe biologic naïve RA subjects on anti-TNF therapies and take measurements of peripheral blood and synovial tissue to assess differences in the IL-17 and Th17 pathways between responders and non-responders. The aim of the study is to test if increased Th17 pathway activity is present in subjects who do not respond clinically to anti-TNF therapy.

Clinical assessments, synovial bio-markers and ultrasound will be used as determinants of clinical response. The study may identify disease characteristics that determine which subjects may be more likely to respond to anti-TNF therapy, or those who may require either a different treatment option, or additional pathway inhibition in addition to TNF, in order to achieve clinical response.

Conditions

Interventions

DRUG

Anti-TNF Biologics Therapy

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Costantino Pitzalis, MD PhD FRCP · Queen Mary University of London

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-05-24
Completion
2017-05-24

Countries

  • United Kingdom

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 NCT02620189 on ClinicalTrials.gov