NCT02064400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

5 months

First QC Date

February 14, 2014

Last Update Submit

June 25, 2015

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisUltrasoundRemissionQualitative

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Qualitative data relating to patients' views and opinions of their arthritis medication

    At recruitment

  • Simplified Disease Activity Index (SDAI)

    At recruitment

  • Disease Activity Score in 28 joints (DAS-28)

    At recruitment

  • Disease Activity Score (DAS)

    At recruitment

Study Arms (1)

Observational study group

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

Other: Musculoskeletal UltrasoundOther: Semi-structured patient interview

Interventions

Musculoskeletal UltrasoundOTHER

7-joint musculoskeletal ultrasound scan

Observational study group
Semi-structured patient interviewOTHER

Semi-structured patient interview

Observational study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Secondary care rheumatology outpatient clinic

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 31225429DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • John D Isaacs, PhD, MB BS

    Newcastle University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2014

First Posted

February 17, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

June 26, 2015

Record last verified: 2015-06

Locations

GB(1)