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NCT Number: NCT02064400

Pilot Study of Ultrasound in Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Musculoskeletal Outpatient Department, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

musculoskeletal ultrasound

Other

7-joint musculoskeletal ultrasound scan

Semi-structured patient interview

Other

Semi-structured patient interview

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Other

Collaborators

  • Newcastle University
  • Wellcome Trust

Registry information

Official study title

A Pilot Study of Musculoskeletal Ultrasound Assessment in Patients With Rheumatoid Arthritis

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 17, 2014
Registry last updated
Jun 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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