Arthritis, RheumatoidNCT03285191
Subject Insights to Understand Rheumatoid Arthritis (RA)
An observational study of Arthritis, Rheumatoid, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Numerical rating scale and Real-time data capture app
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jul 2017to 17 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Bollington, Cheshire, SK10 5JB
About this study
Official title: Patient Interviews to Better Understand Disease Experience and Unmet Treatment Needs in Rheumatoid Arthritis
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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Numerical rating scale, Real-time data capture app
- Keywords
- NRS, Concept elicitation, Real-time data capture, Rheumatoid arthritis, GSK3196165
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Numerical rating scaleOther
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).
Real-time data capture appOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Numerical rating scale; Other: Real-time data capture app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with RA participating in CE interviews
CE interviews will be carried out to explore disease experience with respect to symptoms, impacts and treatment/surgical experiences.
Measured: 1 day
Secondary outcomes (2)
Analysis of RA experience by using real-time data data capture task
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'.
Measured: Up to 7 days
Preparation of the conceptual model
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.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start3 Jul 2017
- Primary completion17 Aug 2017
- Study completion17 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285191
- Sponsor's protocol ID
- 206577
- Status last verified
- Aug 2018
- First submitted
- 29 Jun 2017
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Interviews to Better Understand Disease Experience and Unmet Treatment Needs in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03285191
- Acronym / sponsor ID
- 206577
- Conditions
- Arthritis, Rheumatoid
- Keywords
- NRS, Concept elicitation, Real-time data capture, Rheumatoid arthritis, GSK3196165
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 17 Aug 2017 (actual)
- Study completion
- 17 Aug 2017 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects participating in the CE interview | – | Other: Numerical rating scaleThirty subjects (comprised of n=15 csDMARD-IR and n=15 bDMARD-IR) will participate in the CE interview. |
| Subjects participating in interview and real-time data capture | – | Other: Numerical rating scale, Other: Real-time data capture appTen of the thirty CE interview participants will be offered the opportunity to participate in the real-time data capture App substudy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Numerical rating scaleFollowing 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 | Subjects participating in interview and real-time data capture, Subjects participating in the CE interview |
| Real-time data capture appReal 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. | Other | Subjects participating in interview and real-time data capture |
Primary outcome
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.
2 secondary outcomes
Analysis of RA experience by using real-time data data capture task
Time frame: Up to 7 days
Preparation of the conceptual model
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Results for study 206577 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with RA participating in CE interviews (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.