Unmet need in rheumatoid arthritis
Research type
Research Study
Full title
Patient survey of unmet need and burden of illness in rheumatoid arthritis
IRAS ID
179147
Contact name
Rob Arbuckle
Contact email
Sponsor organisation
Pfizer Ltd
Clinicaltrials.gov Identifier
15/SC/0393, South Central - Hampshre A
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
This is a mixed-methods, non-interventional study to identify any unmet need in patients with rheumatoid arthritis and to further understand the burden of rheumatoid arthritis on patients who have had an inadequate response or shown intolerance to first line therapies. The study is sponsored by Pfizer and is being conducted by Adelphi Values, a health outcomes consultancy.
Qualitative interviews will be conducted with patients (n=10) and clinicians (n=2) in the UK. Similar interviews will also be conducted in France, Germany, Spain and Italy with the same sample size in each country. Patient and clinicians will be asked to provide written informed consent before participating in any study related activities and before any of the patients’ medical information is shared with Adelphi Values. With patient consent, some clinical and demographic information will also be collected about the patient. Before the interview, patients will complete two short questionnaires (HAQ-DI and EQ-5D) to assess their level of physical functioning. The qualitative interview will last approximately 60-minutes and will be conducted by a trained interviewer at a convenient location. It will be made clear to all patients and clinicians that they are free to talk as much or as little as they like and are free to withdraw from the study at any point. During the interview patients will be asked about their experience of rheumatoid arthritis, how it affects their physical functioning and emotional wellbeing and their experience with arthritis treatments. Similarly, clinicians will be asked about the patient burden of arthritis and the effectiveness of different treatments in their clinical experience. Patients will be compensated for their time to take part in the study.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
15/NE/0233
Date of REC Opinion
30 Jun 2015
REC opinion
Favourable Opinion