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Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Rheumatoid Arthritis

NCT02528292 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2015-08-19

No results posted yet for this study

Summary

This study will be an open label observational prospective study assessing the clinical efficacy of antiTNFα therapy and the alteration/impact on the synovial tissue, with specific regard to lymphoid aggregation, over a period of 12 months in patients with rheumatoid arthritis.

Rheumatoid arthritis (RA) is one of the most important chronic inflammatory disorders in the UK. It affects approximately 1% of adults and causes considerable morbidity, substantially reduces quality of life and has a significant mortality. It results in large direct medical costs as well as extensive indirect social costs. Despite the significant therapeutic progress following the introduction of antiTNFα, a cure for RA is still elusive. At present the reasons for the variation in clinical response are not known. The main aim of this study is to test the hypothesis that there are distinct molecular and cellular phenotypes present within the synovial tissue that define specific disease subsets and provide characteristic prognostic implications. In particular, the aim is to assess the relationship between the presence of ectopic lymphoneogenesis (ELN) within the rheumatoid synovial membrane and response to antiTNFα therapy.

Conditions

Interventions

PROCEDURE

Synovial biopsy

Ultrasound guided synovial biopsy of inflamed joint

DRUG

Anti-TNF therapy

Therapy will include, but not limited to Etanercept, Certolizumab Pegol, Adalimumab and Infliximab

Sponsors & Collaborators

  • Barts & The London NHS Trust

    lead OTHER

Principal Investigators

  • Costantino Pitzalis, MD, PhD · Barts and the London NHS Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2018-01-31
Completion
2018-04-30

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 NCT02528292 on ClinicalTrials.gov