An observational study in Arthritis, Rheumatoid, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-15.
Sponsored by GlaxoSmithKline · Observational
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Among 44 studies in Arthritis, Rheumatoid by GlaxoSmithKline — 1 open to participants now, 1 under way, none of them phase 3. Arthritis, Rheumatoid · GlaxoSmithKline.
Among the 44 studies in Arthritis, Rheumatoid by GlaxoSmithKline, this one is one of 3 that started in 2017, is one of 3 observational ones, and was the 36th registered.
3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.
Browse Arthritis, Rheumatoid studies →1 of the 44 studies in Arthritis, Rheumatoid by GlaxoSmithKline is open now, in 9 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in Argentina, Brazil, France and 6 more countries
Ages 18–70
By country, each count listing its studies:
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
44 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 19 · Phase 3 8
First in 2001; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 176 across 1,017 observational studies indexed under Arthritis, Rheumatoid.
Median enrollment 52 across the 40 interventional studies, 32 across the 3 observational. Of the 40 that completed or were terminated, 17 (43%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 44 studies in Arthritis, Rheumatoid by GlaxoSmithKline, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Thirty English speaking subjects from the US with RA who are inadequate responders to csDMARDs and/or bDMARDs will be included in this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For subjects taking part in real-time data capture:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Thirty subjects (comprised of n=15 csDMARD-IR and n=15 bDMARD-IR) will participate in the CE interview.
Other: Numerical rating scale
Ten of the thirty CE interview participants will be offered the opportunity to participate in the real-time data capture App substudy.
Other: Numerical rating scale · Other: Real-time data capture app
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 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.
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.
Time frame: 1 day
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'.
Time frame: 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.
Time frame: Up to 7 days
Ran from Jul 2017 to primary completion in Aug 2017, 1 month.
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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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