Rheumatoid Arthritis Clinical Trial
Official title:
A Pilot Study of Musculoskeletal Ultrasound Assessment in Patients With 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.
Status | Completed |
Enrollment | 17 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United Kingdom | Musculoskeletal Outpatient Department, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne |
Lead Sponsor | Collaborator |
---|---|
Newcastle-upon-Tyne Hospitals NHS Trust | Newcastle University, Wellcome Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evidence of reliability of intra- and inter-rater ultrasound agreement for power Doppler synovitis score | Defined as Kappa statistic of at least 0.4. | At recruitment | No |
Secondary | Qualitative data relating to patients' views and opinions of their arthritis medication | Based upon data collected by a semi-structured interview approach and analysed using standard qualitative techniques. | At recruitment | No |
Secondary | Simplified Disease Activity Index (SDAI) | At recruitment | No | |
Secondary | Disease Activity Score in 28 joints (DAS-28) | At recruitment | No | |
Secondary | Disease Activity Score (DAS) | At recruitment | No |
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