Rheumatoid ArthritisPRISMNCT01707186
Pictorial Representation of Illness and Self Measure
An observational study of Rheumatoid Arthritis, run by University of Oxford at 1 site in United Kingdom.
Trial summary
PRISM (Pictorial Representation of Illness and Self Measure) has been developed since the mid-1990s; the task was first developed as a simple measure of how a person was coping with his or her experience of illness. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 220 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Oct 2012to 30 Jun 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with rheumatoid arthritis from hospital clinics
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Written confirmed diagnosed of rheumatoid arthritis
Who cannot join
- A diagnosis of any of the following:
- Multiple sclerosis
- Motor neurone disease
- Parkinson's disease
- Alzheimer's disease
- Depression or anxiety disorders as identified using the Patient depression screening questions from the patient health questionnaire 9 (PHQ9).
Trial locations and contacts
1 site in 1 country.
About this study
PRISM (Pictorial Representation of Illness and Self Measure) has been developed since the mid-1990s; the task was first developed as a simple measure of how a person was coping with his or her experience of illness. This is an international, multicentre study to evaluate the PRISM tool for the assessment of suffering in rheumatoid arthritis at different stages of the illness and the effect of treatment intervention. There are 5 sites: Berlin, Oxford, Limoges, Montreal and Queensland. The study will recruit 200 patients in total.
In addition to the procedures for the patient's routine clinical visit, the patients will be invited to answer a series of questionnaires and donate 20ml blood sample. Patients will be asked to attend 3 times over 24 weeks
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1A | Early phase, requiring change in treatment | |
| Group 2 | Established phase, stable treatment | |
| Group 2A | Established phase, requiring a change in treatment | |
| Group 1 | Early phase, stable treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRISM/PRISM+
Questionnaires
Measured: 30 September 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study start18 Oct 2012
- Primary completion30 Jun 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Sponsor
- Investigators
- Peter Taylor, FRCP, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707186
- Sponsor's protocol ID
- 2010930
- Acronym
- PRISM
- Status last verified
- Oct 2017
- First submitted
- 11 Oct 2012
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pictorial Representation of Illness and Self Measure
- ClinicalTrials.gov ID
- NCT01707186
- Acronym / sponsor ID
- PRISM / 2010930
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- 18 Oct 2012 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 16 Oct 2012 (estimated)
- 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.
PRISM (Pictorial Representation of Illness and Self Measure) has been developed since the mid-1990s; the task was first developed as a simple measure of how a person was coping with his or her experience of illness. This is an international, multicentre study to evaluate the PRISM tool for the assessment of suffering in rheumatoid arthritis at different stages of the illness and the effect of treatment intervention. There are 5 sites: Berlin, Oxford, Limoges, Montreal and Queensland. The study will recruit 200 patients in total.
In addition to the procedures for the patient's routine clinical visit, the patients will be invited to answer a series of questionnaires and donate 20ml blood sample. Patients will be asked to attend 3 times over 24 weeks
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1A | – | –Early phase, requiring change in treatment |
| Group 2 | – | –Established phase, stable treatment |
| Group 2A | – | –Established phase, requiring a change in treatment |
| Group 1 | – | –Early phase, stable treatment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rheumatoid arthritis from hospital clinics
Key inclusion criteria (3 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Written confirmed diagnosed of rheumatoid arthritis
Key exclusion criteria (6 listed)
- A diagnosis of any of the following:
- Multiple sclerosis
- Motor neurone disease
- Parkinson's disease
- Alzheimer's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PRISM/PRISM+
Time frame: 30 September 2015
Questionnaires
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 30 Apr 2019.
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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.
Peter Taylor, FRCP, PhD principal investigator
University of Oxford
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 Rheumatoid Arthritis, run by University of Oxford 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 3 inclusion and 6 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 30 Apr 2019. 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?
PRISM/PRISM+ (time frame: 30 September 2015). 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 30 Apr 2019.