Rheumatoid Arthritis Clinical Trial
Official title:
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
NCT number | NCT01060098 |
Other study ID # | 2104091 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 2010 |
Est. completion date | December 2012 |
Verified date | January 2020 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion criteria: - Only anti-TNF naïve patients will be included in this study - Patients between 18 to 80 years of age - Patients due to start treatment with anti-TNF blocking agents - etanercept or adalimumab Patients with rheumatoid arthritis - Only patients meeting the 1987 American College of Rheumatology (ACR) revised classification criteria for rheumatoid arthritis will be included - Patients should have active rheumatoid arthritis, defined by an initial DAS28 score >5.1 - Patients should have at least 1 joint suitable for synovial biopsy - Patients can be on concurrent DMARDs but they should have been on a stable dose of DMARD for at least 1 month prior to study entry - Patients can be on a concurrent dose of glucocorticoids (up to 10mg daily) and they should have been on a stable dose for at least 4 weeks prior to study entry Patients with psoriatic arthritis - Patients should have a secure diagnosis of psoriatic arthritis determined by a rheumatologist - Patients with psoriatic arthritis included in this study should have evidence of concurrent psoriatic skin lesions at the time of study entry - Patients should have at least one joint suitable for synovial biopsy - Patients can be on concurrent DMARDs - they should be on a stable dose of DMARD for at least 1 month prior to study entry Patients with Ankylosing spondylitis - Patient should fulfil the Modified New York Criteria for diagnosis of ankylosing spondylitis - Patients can be on concurrent NSAIDs - Patients can be on concurrent DMARDs - they should be on a stable dose of DMARD for at least 1 month prior to study entry Exclusion Criteria: - Patients who have been previously treated with anti-TNF therapy for whatever reason - Patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who do not fulfil the diagnostic criteria for these conditions as above - Patient who have received an intra-articular injection of steroids or have received an intra-muscular injection of depot steroid to treat disease flare in the preceding 4 weeks prior to commencing anti-TNF therapy. - Patients with intercurrent, active infection of any type, excluding the common cold |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Kennedy Institute Clinical Trials Unit, 4Wl, Charing Cross Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
United Kingdom,
Hull DN, Cooksley H, Chokshi S, Williams RO, Abraham S, Taylor PC. Increase in circulating Th17 cells during anti-TNF therapy is associated with ultrasonographic improvement of synovitis in rheumatoid arthritis. Arthritis Res Ther. 2016 Dec 23;18(1):303. — View Citation
Hull DN, Williams RO, Pathan E, Alzabin S, Abraham S, Taylor PC. Anti-tumour necrosis factor treatment increases circulating T helper type 17 cells similarly in different types of inflammatory arthritis. Clin Exp Immunol. 2015 Sep;181(3):401-6. doi: 10.11 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of Effector T Helper Type 17 Cells in Peripheral Blood | The frequency of circulating Th17 cells was determined by IL17 enzyme-linked immunospot assay (Elispot) and flow cytometry (fluorescence-activated cell sorting (FACS)). | Week 0, Week 12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |