Pilot Study of Ultrasound in Rheumatoid Arthritis

NCT ID: NCT02064400

Last Updated: 2015-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Observational study group

Musculoskeletal ultrasound (all patients) and semi-structured patient interview (anticipated maximum 15 patients)

Musculoskeletal Ultrasound

Intervention Type OTHER

7-joint musculoskeletal ultrasound scan

Semi-structured patient interview

Intervention Type OTHER

Semi-structured patient interview

Interventions

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Musculoskeletal Ultrasound

7-joint musculoskeletal ultrasound scan

Intervention Type OTHER

Semi-structured patient interview

Semi-structured patient interview

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Newcastle University

OTHER

Sponsor Role collaborator

Wellcome Trust

OTHER

Sponsor Role collaborator

Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John D Isaacs, PhD, MB BS

Role: PRINCIPAL_INVESTIGATOR

Newcastle University

Locations

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

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Baker KF, Isaacs JD, Thompson B. "Living a normal life": a qualitative study of patients' views of medication withdrawal in rheumatoid arthritis. BMC Rheumatol. 2019 Jun 13;3:2. doi: 10.1186/s41927-019-0070-y. eCollection 2019.

Reference Type DERIVED
PMID: 31225429 (View on PubMed)

Other Identifiers

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NUTH6919

Identifier Type: -

Identifier Source: org_study_id

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