Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Rheumatoid Arthritis | Patients with active Rheumatoid Arthritis with a DAS 28 score of greater than 5.1 and eligible for anti-TNF alpha therapy according to National Institute for Clinical Excellence guidelines will be recruited in this study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synovial biopsy | Procedure | Ultrasound guided synovial biopsy of inflamed joint |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of change in synovial ectopic lymphoneogenesis with EULAR response criteria using DAS28 | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disability and health status assessed using the HAQ questionnaire | Baseline and 12 months | |
| X-ray progression | Progression of x-ray damage of hand and feet using modified van der heidje / sharp score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients within Rheumatology secondary care services with active Rheumatoid Arthritis will be recruited
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Costantino Pitzalis, MD, PhD | Barts and the London NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Department, Mile End Hospital, Barts and The Royal London NHS Trust | London | London | EH1 4DG | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Synovial tissue and blood
| Anti-TNF therapy | Drug | Therapy will include, but not limited to Etanercept, Certolizumab Pegol, Adalimumab and Infliximab |
|
| Baseline and 12 months |
| Change in synovial histomorphology with treatment | baseline and 3 months |
| Correlation of peripheral blood lymphocytes including, Treg markers and, B cell subsets | baseline and 12 months |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |