Inflammatory DiseaseNCT05458531
Monitoring of Inflammatory Conditions
An observational study of Inflammatory Disease and Crohn Disease, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
People with inflammatory diseases treated with immune-suppressing medication are recommended to have regular blood-tests to monitor for potential side-effects of this treatment on their blood count, liver and kidneys. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Disease, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Questionnaire and Semi-structured interview
- How many people
- 664 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2022to 8 Feb 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Secondary care clinic and general population
Who may be able to join
- Age 18 years and over
- Ability to give informed consent
- Diagnosis with one of the following inflammatory diseases: rheumatoid arthritis, inflammatory arthritis, inflammatory bowel disease, psoriasis +/- arthritis, ankylosing spondylitis, systemic lupus erythematosus, or reactive arthritis, and
- Currently treated with one of the following immune suppressing treatments for six months or longer: methotrexate, azathioprine, 5-acetyl salicylates, sulfasalazine, mycophenolate mofetil, leflunomide or biologics (anti-TNF-α agents e.g. etanercept, adalimumab, infliximab, golimumab, or certolizumab or their biosimilar).
Who cannot join
- Chronic kidney disease: stage 4 or stage 5
- Chronic liver disease: Autoimmune hepatitis, hepatitis B or C, cirrhosis.
- Pre-existing haematological abnormalities: Myelodysplasia, primary haematological diseases with neutropenia or thrombocytopenia.
- Dementia.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Nottinghamshire, NG5 1PB
About this study
Official title: Exploring Patient and Healthcare Professional Views and Experiences of the Current and Recommended Monitoring Strategies for Inflammatory Conditions Treated With Commonly Used Immune Suppressing Drugs
People with inflammatory diseases treated with immune-suppressing medication are recommended to have regular blood-tests to monitor for potential side-effects of this treatment on their blood count, liver and kidneys. However, it is not clear that monitoring is needed as frequently as currently recommended in the long-term, with side-effects being rare after one year of treatment. A study is currently underway to determine the optimal blood-test monitoring strategy which is cost-effective but still safe. Any changes in the monitoring strategy must be acceptable to patients and the healthcare professionals (HCP) that treat them.
This study aims to measure how often patients' with common inflammatory conditions on long-term immune suppressing medication attend their monitoring blood tests as currently recommended, and uncover patients' and HCP views and experiences of the current blood-test monitoring strategy, and the acceptability of potential changes to this in the future.
Read more
Firstly, patients with an inflammatory condition on long-term immune suppressing treatment will be invited to complete a questionnaire which will ask about their demographic information, medical condition(s), immune-suppressing treatment, adherence to the monitoring blood tests and willingness to take part in an interview. Then, both patients and HCPs who care for such patients will be invited to take part in a single, semi-structured interview. Interviews will be face-to-face, by telephone or video-call, last up to one hour and digitally audio-recorded. Patient interviews will explore their perceptions of risk, benefits and experiences of current testing, and views on the new testing frequencies emerging from the study prior. HCP interviews will explore their perceptions of current testing including, the practicalities, usefulness, risks and benefits of the blood tests, and views on the new testing frequencies emerging from the study prior.
The findings will shape the recommendations for a new monitoring strategy, ensuring it is acceptable to patients and HCPs.
- Conditions
- Inflammatory Disease, Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis, System; Lupus Erythematosus, Psoriatic Arthritis
- Being tested
- Questionnaire, Semi-structured interview
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Arthritis, Psoriatic, Arthritis, Reactive, Arthritis, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
A single questionnaire
Semi-structured interviewOther
A single semi-structured qualitative interview conducted face-to-face or by telephone or video-conference call.
| Study group | Role | What they receive |
|---|---|---|
| Patients with an inflammatory disease taking immune-suppressing medication | Aged 18 years and over, able to give consent, diagnosed with one of the above inflammatory conditions and currently treated with one of the following immune-suppressing treatments for six months or longer: methotrexate, azathioprine, 5-acetyl salicylates, sulfasalazine, mycophenolate mofetil, leflunomide or biologics. Receives: Other: Questionnaire; Other: Semi-structured interview | |
| Healthcare professionals | Consultants, general practitioners (GPs), nurse specialists, practice nurses and pharmacists with experience of prescribing and monitoring long-term immune-suppressing treatments for the above inflammatory diseases Receives: Other: Semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore patient and HCP views and experiences of the current monitoring strategies.
This will be determined through interview
Measured: 1 day
To measure patient adherence with current monitoring recommendations.
This will determined through patient questionnaire
Measured: 1 day
To explore the acceptability of the new recommended monitoring strategy emerging from a prior modelling exercise, to patients and HCPs.
This will be determined through interview
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start28 Jun 2022
- Primary completion8 Feb 2023
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abhishek Abhishek, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458531
- Sponsor's protocol ID
- 21042
- Status last verified
- Feb 2024
- First submitted
- 11 Jul 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abhishek A, Carroll C, Essat M, Leaviss J, Nakafero G, Fuller A, Grainge MJ, Hancox J, Williams HC, Card T, Taal MW, Aithal GP, Fox CP, Mallen CD, Vedhara K, van der Windt DA, Stevenson MD, Riley RD. Blood-test monitoring strategies for patients established on immune-suppressing drugs: a mixed-methods study. Health Technol Assess. 2026 Aug;30(64):1-382. doi: 10.3310/PLRF8845.
PubMed 42663270
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Patient and Healthcare Professional Views and Experiences of the Current and Recommended Monitoring Strategies for Inflammatory Conditions Treated With Commonly Used Immune Suppressing Drugs
- ClinicalTrials.gov ID
- NCT05458531
- Acronym / sponsor ID
- 21042
- Conditions
- Inflammatory Disease, Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis, System; Lupus Erythematosus, Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 664 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 14 Jul 2022 (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.
People with inflammatory diseases treated with immune-suppressing medication are recommended to have regular blood-tests to monitor for potential side-effects of this treatment on their blood count, liver and kidneys. However, it is not clear that monitoring is needed as frequently as currently recommended in the long-term, with side-effects being rare after one year of treatment. A study is currently underway to determine the optimal blood-test monitoring strategy which is cost-effective but still safe. Any changes in the monitoring strategy must be acceptable to patients and the healthcare professionals (HCP) that treat them.
This study aims to measure how often patients' with common inflammatory conditions on long-term immune suppressing medication attend their monitoring blood tests as currently recommended, and uncover patients' and HCP views and experiences of the current blood-test monitoring strategy, and the acceptability of potential changes to this in the future.
Firstly, patients with an inflammatory condition on long-term immune suppressing treatment will be invited to complete a questionnaire which will ask about their demographic information, medical condition(s), immune-suppressing treatment, adherence to the monitoring blood tests and willingness to take part in an interview. Then, both patients and HCPs who care for such patients will be invited to take part in a single, semi-structured interview. Interviews will be face-to-face, by telephone or video-call, last up to one hour and digitally audio-recorded. Patient interviews will explore their perceptions of risk, benefits and experiences of current testing, and views on the new testing frequencies emerging from the study prior. HCP interviews will explore their perceptions of current testing including, the practicalities, usefulness, risks and benefits of the blood tests, and views on the new testing frequencies emerging from the study prior.
The findings will shape the recommendations for a new monitoring strategy, ensuring it is acceptable to patients and HCPs.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with an inflammatory disease taking immune-suppressing medication | – | Other: Questionnaire, Other: Semi-structured interviewAged 18 years and over, able to give consent, diagnosed with one of the above inflammatory conditions and currently treated with one of the following immune-suppressing treatments for six months or longer: methotrexate, azathioprine, 5-acetyl salicylates, sulfasalazine, mycophenolate mofetil, leflunomide or biologics. |
| Healthcare professionals | – | Other: Semi-structured interviewConsultants, general practitioners (GPs), nurse specialists, practice nurses and pharmacists with experience of prescribing and monitoring long-term immune-suppressing treatments for the above inflammatory diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary care clinic and general population
Key inclusion criteria (4 listed)
- Age 18 years and over
- Ability to give informed consent
- Diagnosis with one of the following inflammatory diseases: rheumatoid arthritis, inflammatory arthritis, inflammatory bowel disease, psoriasis +/- arthritis, ankylosing spondylitis, systemic lupus erythematosus, or reactive arthritis, and
- Currently treated with one of the following immune suppressing treatments for six months or longer: methotrexate, azathioprine, 5-acetyl salicylates, sulfasalazine, mycophenolate mofetil, leflunomide or biologics (anti-TNF-α agents e.g. etanercept, adalimumab, infliximab, golimumab, or certolizumab or their biosimilar).
Key exclusion criteria (4 listed)
- Chronic kidney disease: stage 4 or stage 5
- Chronic liver disease: Autoimmune hepatitis, hepatitis B or C, cirrhosis.
- Pre-existing haematological abnormalities: Myelodysplasia, primary haematological diseases with neutropenia or thrombocytopenia.
- Dementia.
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 |
|---|---|---|
| QuestionnaireA single questionnaire | Other | Patients with an inflammatory disease taking immune-suppressing medication |
| Semi-structured interviewA single semi-structured qualitative interview conducted face-to-face or by telephone or video-conference call. | Other | Healthcare professionals, Patients with an inflammatory disease taking immune-suppressing medication |
Primary outcome
To explore patient and HCP views and experiences of the current monitoring strategies.
Time frame: 1 day
This will be determined through interview
To measure patient adherence with current monitoring recommendations.
Time frame: 1 day
This will determined through patient questionnaire
To explore the acceptability of the new recommended monitoring strategy emerging from a prior modelling exercise, to patients and HCPs.
Time frame: 1 day
This will be determined through interview
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 28 Feb 2024.
- Derived from this study: PubMed 42663270Abhishek A, Carroll C, Essat M, Leaviss J, Nakafero G, Fuller A, Grainge MJ, Hancox J, Williams HC, Card T, Taal MW, Aithal GP, Fox CP, Mallen CD, Vedhara K, van der Windt DA, Stevenson MD, Riley RD. Blood-test monitoring strategies for patients established on immune-suppressing drugs: a mixed-methods study. Health Technol Assess. 2026 Aug;30(64):1-382. doi: 10.3310/PLRF8845.
- Individual participant dataSharing planned: No
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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.
Abhishek Abhishek principal investigator
University of Nottingham
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 Inflammatory Disease and Crohn Disease, run by University of Nottingham 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 4 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 28 Feb 2024. 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?
To explore patient and HCP views and experiences of the current monitoring strategies. (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05458531, which also lists 1 linked publication.
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 28 Feb 2024.