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
Sponsor:
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
  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:

  1. Patients attending Early RA clinics with newly diagnosed RA or anti−CCP +ve Undifferentiated Arthritis (UA)
  2. Active disease (DAS28 > 3.2)
  3. DMARD naïve or DMARD monotherapy for less than 6 weeks
  4. Aged 18 or more

Exclusion Criteria:

  1. Significant liver disease and/or abnormality of liver function tests
  2. AST / ALT > x2 normal, Alkaline Phosphatase > x2.5 normal
  3. Renal impairment − serum creatinine > 200 μmol/l, eGFR < 30
  4. Cytopenias − white cell count < 4.0, haemoglobin < 10, platelet < 150
  5. Pregnancy or planned pregnancy
  6. Contraindication to MRI
  7. Other co−morbid condition that in the opinion of the investigator would preclude the use of sequential or combination DMARD therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by NHS Greater Glasgow and Clyde

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 24, 2014