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Pilot Study of Ultrasound in Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02064400
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : June 26, 2015
Sponsor:
Collaborators:
Newcastle University
Wellcome Trust
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

Brief Summary:

Little is currently known as to the predictive value of ultrasound in guiding the decision to taper drug treatment in patients with stable rheumatoid arthritis, nor the influence that patients' views and opinions regarding their medications may have upon this. In this study, patients with stable rheumatoid arthritis will undergo a simple examination of their joints to look for any swelling or tenderness followed by an ultrasound scan to look for joint inflammation. Half of the patients will also complete an interview to assess their views and opinions of arthritis drug treatment. The study will be completed in a single patient visit - no invasive tests will be performed, and no changes to treatment will be made.

This study is being conducted as part of a Masters degree from Newcastle University. The results of this study will be used to inform the feasibility of inclusion of ultrasound assessment within the design of a future PhD study to investigate potential markers of remission in patients with rheumatoid arthritis.


Condition or disease Intervention/treatment
Rheumatoid Arthritis Other: Musculoskeletal Ultrasound Other: Semi-structured patient interview

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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Pilot Study of Musculoskeletal Ultrasound Assessment in Patients With Rheumatoid Arthritis
Study Start Date : February 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Observational study group
Musculoskeletal ultrasound (all patients) and semi-structured patient interview (anticipated maximum 15 patients)
Other: Musculoskeletal Ultrasound
7-joint musculoskeletal ultrasound scan

Other: Semi-structured patient interview
Semi-structured patient interview




Primary Outcome Measures :
  1. Evidence of reliability of intra- and inter-rater ultrasound agreement for power Doppler synovitis score [ Time Frame: At recruitment ]
    Defined as Kappa statistic of at least 0.4.


Secondary Outcome Measures :
  1. Qualitative data relating to patients' views and opinions of their arthritis medication [ Time Frame: At recruitment ]
    Based upon data collected by a semi-structured interview approach and analysed using standard qualitative techniques.

  2. Simplified Disease Activity Index (SDAI) [ Time Frame: At recruitment ]
  3. Disease Activity Score in 28 joints (DAS-28) [ Time Frame: At recruitment ]
  4. Disease Activity Score (DAS) [ Time Frame: At recruitment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Secondary care rheumatology outpatient clinic
Criteria

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis with symptom onset at least 12 months previously
  • Current disease-modifying anti-rheumatic drug (DMARD) therapy or biologic therapy
  • Currently stable arthritis defined as no change in DMARD treatment over previous 6 months, and no use of steroids (enteral, parenteral or intra-articular) over previous 6 months

Exclusion Criteria:

  • Inability to provide informed consent
  • Current or recent (within 4 months) participation within another clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064400


Locations
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United Kingdom
Musculoskeletal Outpatient Department, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Newcastle University
Wellcome Trust
Investigators
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Principal Investigator: John D Isaacs, PhD, MB BS Newcastle University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02064400    
Other Study ID Numbers: NUTH6919
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015
Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Rheumatoid arthritis
Ultrasound
Remission
Qualitative
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases