NCT02528292

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

Phase 4 Study of Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Patients With Rheumatoid Arthritis Undergoing Treatment With Anti-TNF Therapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 24 (estimated)
• Sponsor: Barts & The London NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-10-01
• Primary completion: 2018-01-01
• Completion: 2018-04-01
• First posted: 2015-08-19
• Last updated: 2015-08-19

Locations

1 site across 1 country: United Kingdom