Targeting Synovitis in Early Rheumatoid Arthritis (TaSER)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by NHS Greater Glasgow and Clyde.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
NHS Greater Glasgow and Clyde
Collaborators:
University of Glasgow
Chief Scientist Office of the Scottish Government
Wyeth is now a wholly owned subsidiary of Pfizer
Translational Medicine Research Collaboration
Information provided by:
NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT00920478
First received: June 11, 2009
Last updated: September 9, 2009
Last verified: September 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis Polyarthritis |
Other: Musculoskeletal Ultrasound Other: 28 Joint Disease Activity Score |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Targeting Synovitis in Early Rheumatoid Arthritis (TaSER). Intensive Management of Early Rheumatoid Arthritis Using Either Clinical or Musculoskeletal Ultrasound Assessment of Synovitis − a Randomised Study With Blinded Outcome Assessments |
Resource links provided by NLM:
Further study details as provided by NHS Greater Glasgow and Clyde:
Primary Outcome Measures:
- MRI RAMRIS Erosion Score [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
- 44 Joint Disease Activity Score [ Time Frame: Baseline, 3, 6, 9, 12, 15 and 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Plain Xray - Hands and Feet - modified Sharp score [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
- Health Assessment Questionnaire [ Time Frame: Baseline, 3, 6, 9, 12, 15 and 18 months ] [ Designated as safety issue: No ]
- Euro-Qol 5D [ Time Frame: Baseline, 3, 6, 9, 12, 15 and 18 months ] [ Designated as safety issue: No ]
- EULAR response and remission rates [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
- Biomarker analysis - correlation between baseline values and 18 month radiological outcomes [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Adverse event rates [ Time Frame: Throughout period of study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 110 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Control Group
Inflammatory disease activity assessed using DAS28
|
Other: 28 Joint Disease Activity Score
Clinical assessment of synovitis - composite score incorporating 28 tender joint count, 28 swollen joint count, erythrocyte sedimentation rate and patient global VAS
|
|
Experimental: Ultrasound Group
Inflammatory disease activity assessed using musculoskeletal ultrasound (gray scale and power doppler)
|
Other: Musculoskeletal Ultrasound
Gray scale and power doppler - to identify the presence of synovitis
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920478
Contacts
| Contact: James Dale, MBChB, MRCP | +44 141 211 3000 ext 3008 | james.dale@ggc.scot.nhs.uk |
Locations
| United Kingdom | |
| Department of Rheumatology, Gartnavel General Hospital | Recruiting |
| Glasgow, United Kingdom, G12 0YN | |
| Contact: Duncan Porter, MBChB +44 141 211 3000 duncan.porter@ggc.scot.nhs.uk | |
| Principal Investigator: Duncan Porter, MBChB, MRCP | |
| Centre for Rheumatic Diseases, Glasgow Royal Infirmary | Recruiting |
| Glasgow, United Kingdom, G4 0SF | |
| Contact: David McCarey, MBChB, FRCP +44 141 2114965 david.mccarey@ggc.scot.nhs.uk | |
| Principal Investigator: David McCarey, MD, FRCP | |
| Department of Rheumatology, Stobhill Hospital | Recruiting |
| Glasgow, United Kingdom, G21 3UW | |
| Contact: Hilary Wilson, MD, MRCP +44 141 211 3307 hilary.wilson@ggc.scot.nhs.uk | |
| Principal Investigator: Hilary Wilson, MD, MRCP | |
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Chief Scientist Office of the Scottish Government
Wyeth is now a wholly owned subsidiary of Pfizer
Translational Medicine Research Collaboration
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Dr James Dale, University of Glasgow and National Health Service |
| ClinicalTrials.gov Identifier: | NCT00920478 History of Changes |
| Other Study ID Numbers: | GN09RH196, CSO - CAF / 08 / 03 |
| Study First Received: | June 11, 2009 |
| Last Updated: | September 9, 2009 |
| Health Authority: | United Kingdom: National Health Service United Kingdom: Research Ethics Committee |
Keywords provided by NHS Greater Glasgow and Clyde:
|
Rheumatoid arthritis Musculoskeletal Ultrasound Synovitis DMARD |
Etanercept Biomarkers Undifferentiated Inflammatory Polyarthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Synovitis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013