Clinical Trials Directory

Trials / Completed

CompletedNCT01060098

T Cells and TNF (Tumor Necrosis Factor): The Impact of TNF Blockade

T Cells and TNF: The Impact of TNF Blockade on Effector T Cell Populations in Rheumatoid Arthritis and Other Conditions Treated With Anti-TNFalpha Agents

Status
Completed
Phase
Study type
Observational
Enrollment
48 (actual)
Sponsor
Imperial College London · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

We aim to translate these findings into patients with rheumatoid arthritis and other conditions treated with anti-TNF (anti-tumor necrosis factor) therapy, such as psoriatic arthritis and ankylosing spondylitis. Patients from rheumatology clinics within NHS (National Health Service) trusts will be recruited. We will correlate disease activity assessed by clinical parameters, ultrasonography, and questionnaires with biomarkers in the blood and target tissues, such as synovium and skin.

Detailed description

Inflammatory arthritis particularly rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis are potentially disabling conditions which cause joint pain, swelling and deformity and treatments are aimed at preventing these complications. Although treatment has improved with the advent of anti TNF alpha therapies, up to 30% of patients fail to respond to this treatment and in others, treatment is associated with significant side effects. The precise mechanisms of this remain unclear. In addition, there are no sensitive methods available to monitor or predict disease response to treatment aside from testing inflammatory markers in the blood. Understanding the mechanism of action and what governs response to anti TNF therapy will allow development of more specific therapies for inflammatory arthritis. Work in animal models of rheumatoid arthritis has characterised a novel cell type, Th17 cells, important in the inflammatory cascade which are affected in a particular way by anti TNF therapies and may underpin their mechanism of action and side effects.

Conditions

Interventions

TypeNameDescription
DRUGanti-TNF therapy (etanercept or adalimumab)Biological DMARD

Timeline

Start date
2010-04-01
Primary completion
2012-12-01
Completion
2012-12-01
First posted
2010-02-02
Last updated
2020-01-18
Results posted
2020-01-02

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT01060098. Inclusion in this directory is not an endorsement.