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Subject Insights to Understand Rheumatoid Arthritis (RA)

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ClinicalTrials.gov Identifier: NCT03285191
Recruitment Status : Completed
First Posted : September 15, 2017
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date June 29, 2017
First Posted Date September 15, 2017
Last Update Posted Date August 15, 2018
Actual Study Start Date July 3, 2017
Actual Primary Completion Date August 17, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 12, 2017)
Number of subjects with RA participating in CE interviews [ Time Frame: 1 day ]
CE interviews will be carried out to explore disease experience with respect to symptoms, impacts and treatment/surgical experiences.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 12, 2017)
  • Analysis of RA experience by using real-time data data capture task [ Time Frame: Up to 7 days ]
    A subgroup of ten of the thirty subjects participating in the CE interviews will be asked to take part in the real-time data capture task over the course of 7 days and during this time a series of 5-7 questions/tasks will be asked to subjects via the application to explore the experience of the symptoms, HRQoL impacts, treatment of RA and any day-to-day variability that exists in real time'.
  • Preparation of the conceptual model [ Time Frame: Up to 7 days ]
    Data obtained from the CE interviews and real-time data capture as well as literature reviews will be used to develop a conceptual model for RA. Symptom, impact, and treatment concepts which have been identified will be grouped into domains and displayed visually and any identified relationships or trends between domains will also be included in the model. A contents key will be developed to show the source of the concept.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Subject Insights to Understand Rheumatoid Arthritis (RA)
Official Title Patient Interviews to Better Understand Disease Experience and Unmet Treatment Needs in Rheumatoid Arthritis
Brief Summary Rheumatoid arthritis (RA) is a chronic, systemic autoimmune disease affecting the joints and can lead to joint pain, swelling, redness and stiffness and can cause deformity, loss of strength and immobility. This cross-sectional qualitative study aims to explore the burden of established RA by conducting semi-structured Concept elicitation (CE) interviews (60 minutes duration) and real-time data capture task. The conceptual model developed from this data will be used to support the development of GSK3196165, a recombinant human monoclonal antibody (mAb) targeted for the treatment of RA. The CE interviews will explore the subject experience of RA and will collect information about symptoms, disease impact on functioning and health related quality of life (HRQoL), and treatment experiences/impacts of the condition and the language used by subjects to describe them. Following the CE interview, subjects will be asked to complete a brief symptom ranking exercise where they will need to rank how bothersome each RA symptom is and how important it would be to improve with treatment on a 1-5 numerical rating scale (NRS). After the interviews, the real-time disease experience of subjects will be captured by the real-time data capture app-based activity over a period of 7 days. Approximately 30 English-speaking subjects from the United States (US) with RA who are inadequate responders of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and/or (bDMARDs) will participate in the interviews and of these, 10 subjects will be offered the opportunity to participate in the real-time data capture sub study.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Thirty English speaking subjects from the US with RA who are inadequate responders to csDMARDs and/or bDMARDs will be included in this study.
Condition Arthritis, Rheumatoid
Intervention
  • Other: Numerical rating scale
    Following the concept elicitation interview, participants will be presented with a list of typical RA symptoms and asked to rank how bothersome each symptom is and how important it would be to improve with treatment on a 1-5 numerical rating scale (NRS).
  • Other: Real-time data capture app
    Real time data capture app is a smart-phone or web-based application which will allow the subjects to provide responses about their experience of HOA in real-time via varying video, audio, photographic and text forms using a study-specific application on their own smart device. Up to ten of the thirty interview participants can participate in the app sub study, which is voluntary.
Study Groups/Cohorts
  • Subjects participating in the CE interview
    Thirty subjects (comprised of n=15 csDMARD-IR and n=15 bDMARD-IR) will participate in the CE interview.
    Intervention: Other: Numerical rating scale
  • Subjects participating in interview and real-time data capture
    Ten of the thirty CE interview participants will be offered the opportunity to participate in the real-time data capture App substudy.
    Interventions:
    • Other: Numerical rating scale
    • Other: Real-time data capture app
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 12, 2017)
30
Original Actual Enrollment Same as current
Actual Study Completion Date August 17, 2017
Actual Primary Completion Date August 17, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or female, aged >=18 years or over.
  • Subject has a diagnosis of rheumatoid arthritis and has had this diagnosis for at least 6 months.
  • Subject has a minimum of four swollen and tender joints.
  • Subject is either an inadequate responder to csDMARDs and has never received a bDMARD or an inadequate responder to bDMARDs (subject may be receiving bDMARDs only or may be continuing csDMARD treatment in addition to receiving a bDMARD).
  • Subject is willing and able to participate in the study and provide written informed consent.
  • Subject is a fluent US-English speaker and is able to read, write and fully understand the US-English language.
  • Subject is willing and able to participate in a 60-minute interview and optional app task to discuss their experience of rheumatoid arthritis.

For subjects taking part in real-time data capture:

  • Subject owns/or has access to either a smartphone [iPhone Operating System (iOS) or android] or tablet which has video, audio/microphone and photographic capabilities and access to either the Apple app store or Google play store to download the app.
  • Subject is willing and able to take part in the real time data application task and respond to a series of questions/tasks fielded via the application over the course of seven days and is willing to respond to some brief questions following the real-time data capture task about their experience of using the app and completing the tasks, in a 5-10 minute telephone call.
  • Subject would feel comfortable recording short videos of themselves and providing audio commentary in response to app questions/tasks.

Exclusion Criteria:

  • Subject has a history of other inflammatory rheumatological or autoimmune disorders that are not secondary to RA.
  • Subject has significant unstable or uncontrolled acute or chronic disease other than RA.
  • Subject is unwilling or unable to comply with the requirements of the study or has a physical or mental condition that, in the opinion of the physician, may affect the subject's ability to participate in the study, the responses he/she might provide or their ability to provide consent.
  • Subject is currently or has previously been enrolled in a clinical trial for RA in the past year.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03285191
Other Study ID Numbers 206577
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2018