Targeting Synovitis in Early Rheumatoid Arthritis
TaSER
2 other identifiers
interventional
110
1 country
3
Brief Summary
Patients with rheumatoid arthritis are at risk of developing permanent joint damage and disability. This study hopes to identify the most effective way of using existing arthritis medication to minimise the chances of developing permanent disability. Patients will have their arthritis activity assessed using an ultrasound machine. If there is still evidence of active arthritis the participant's arthritis medication will be increased until the arthritis is in remission. The effectiveness of this approach will be compared to the traditional method of assessing arthritis using clinical examination. Furthermore, it is extremely important to identify those patients most at risk of aggressive disease. The investigators hope to produce a more accurate measurement of disease prognosis by examining the relationship between a series of blood tests and how well controlled rheumatoid arthritis appears after 18 months of therapy. Some patients will also be asked to donate samples of joint fluid and joint lining for additional analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 rheumatoid-arthritis
Started Sep 2009
Typical duration for phase_4 rheumatoid-arthritis
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2009
CompletedFirst Posted
Study publicly available on registry
June 15, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedSeptember 10, 2009
September 1, 2009
3 years
June 11, 2009
September 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
MRI RAMRIS Erosion Score
Baseline and 18 months
44 Joint Disease Activity Score
Baseline, 3, 6, 9, 12, 15 and 18 months
Secondary Outcomes (6)
Plain Xray - Hands and Feet - modified Sharp score
Baseline and 18 months
Health Assessment Questionnaire
Baseline, 3, 6, 9, 12, 15 and 18 months
Euro-Qol 5D
Baseline, 3, 6, 9, 12, 15 and 18 months
EULAR response and remission rates
Baseline and 18 months
Biomarker analysis - correlation between baseline values and 18 month radiological outcomes
Baseline
- +1 more secondary outcomes
Study Arms (2)
Control Group
ACTIVE COMPARATORInflammatory disease activity assessed using DAS28
Ultrasound Group
EXPERIMENTALInflammatory disease activity assessed using musculoskeletal ultrasound (gray scale and power doppler)
Interventions
Gray scale and power doppler - to identify the presence of synovitis
Clinical assessment of synovitis - composite score incorporating 28 tender joint count, 28 swollen joint count, erythrocyte sedimentation rate and patient global VAS
Eligibility Criteria
You may qualify if:
- Patients attending Early RA clinics with newly diagnosed RA or anti-CCP +ve Undifferentiated Arthritis (UA)
- Active disease (DAS28 \> 3.2)
- DMARD naïve or DMARD monotherapy for less than 6 weeks
- Aged 18 or more
You may not qualify if:
- Significant liver disease and/or abnormality of liver function tests
- AST / ALT \> x2 normal, Alkaline Phosphatase \> x2.5 normal
- Renal impairment - serum creatinine \> 200 μmol/l, eGFR \< 30
- Cytopenias - white cell count \< 4.0, haemoglobin \< 10, platelet \< 150
- Pregnancy or planned pregnancy
- Contraindication to MRI
- Other co-morbid condition that in the opinion of the investigator would preclude the use of sequential or combination DMARD therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Greater Glasgow and Clydelead
- University of Glasgowcollaborator
- Chief Scientist Office of the Scottish Governmentcollaborator
- Wyeth is now a wholly owned subsidiary of Pfizercollaborator
- Translational Medicine Research Collaborationcollaborator
Study Sites (3)
Department of Rheumatology, Gartnavel General Hospital
Glasgow, G12 0YN, United Kingdom
Department of Rheumatology, Stobhill Hospital
Glasgow, G21 3UW, United Kingdom
Centre for Rheumatic Diseases, Glasgow Royal Infirmary
Glasgow, G4 0SF, United Kingdom
Related Publications (2)
Dale J, Stirling A, Zhang R, Purves D, Foley J, Sambrook M, Conaghan PG, van der Heijde D, McConnachie A, McInnes IB, Porter D. Targeting ultrasound remission in early rheumatoid arthritis: the results of the TaSER study, a randomised clinical trial. Ann Rheum Dis. 2016 Jun;75(6):1043-50. doi: 10.1136/annrheumdis-2015-208941. Epub 2016 Mar 29.
PMID: 27026689DERIVEDDale J, Purves D, McConnachie A, McInnes I, Porter D. Tightening up? Impact of musculoskeletal ultrasound disease activity assessment on early rheumatoid arthritis patients treated using a treat to target strategy. Arthritis Care Res (Hoboken). 2014 Jan;66(1):19-26. doi: 10.1002/acr.22218.
PMID: 24376248DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Duncan R Porter, MBChB, MRCP
Gartnavel General Hospital, Glasgow
- PRINCIPAL INVESTIGATOR
James E Dale, MBChB, MRCP
University of Glasgow
- STUDY CHAIR
Iain B McInnes, PhD, FRCP
University of Glasgow
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 11, 2009
First Posted
June 15, 2009
Study Start
September 1, 2009
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
September 10, 2009
Record last verified: 2009-09