Plain English Summary
Background and study aims
The aim of this study is to explore the effect of a Rheumatoid Arthritis (RA) Information booklet on the disease management of patients with RA who are taking Methotrexate. Methotrexate is the default disease modifying drug (DMARD) for treatment of RA. It is a drug; which has a delayed onset of action and where the majority of patients, even those continuing on treatment, have side effects that they tolerate in order to stay on the drug. Poor disease management in the form of not taking Methotrexate as prescribed can give the impression that the therapy has failed which could have an economic impact on the NHS. Chugai/Roche produced a booklet for people who have Rheumatoid Arthritis. This has been designed to prompt the patients to think about and assess how their treatment suits them.
Who can participate?
Anyone over 18 years of age who has been taking methotrexate at a stable dose for 3 months can take part in this study.
What does the study involve?
All you have to do to take part in this study, is to sign a consent form to allow us to give you 2 questionnaires to complete, then take approximately 10 mls of blood during your routine blood monitoring visit. You will not need any extra needles in your arm. We will randomise you to receiving the Roche Information Booklet or the Arthritis Research UK information leaflet. Then, when you return in 3 – 6 months to repeat your blood monitoring we will ask you to complete the questionnaires again and we will take 10 mls of blood during your blood monitoring so that you don’t need an extra needle in your arm. This whole process should not take more than an extra 10 minutes to your regular appointment on each occasion. That would complete your participation in the study. However, if you would like to know the results, please leave your details with the study team and we will post or email our results to you.
What are the possible benefits and risks of participating?
You would have the opportunity to learn more about your condition and the medication you take. We will give you the Roche education booklet when you return for your second visit. We hope that this information will empower you to ask more questions when you see your doctor or nurse and help you to manage your arthritis better. Also, discovery through research studies like this could lead to benefits in the future for people like yourselves who have similar conditions.
There are no particular risks of taking part in this study as we do not intend to take blood samples from you unless you are having this done as part of your normal routine care. Your blood samples will be analysed at the University of Newcastle Upon Tyne. However there is no risk of any identifiable data being released as all of the samples will be anonymised and only your unique study number will identify them. Newcastle University would like to keep any unused samples for further research, but these would also be completely anonymised.
Where is the study run from?
North Tyneside General Hospital, UK
When is the study starting and how long is it expected to run for?
March 2019 to February 2021 (updated 05/08/2020, previously: September 2020)
Who is funding the study?
Chugai Pharma Europe Ltd. and the National Institute for Health Research
Who is the main contact?
Sandra Robinson, sandra.robinson3@nhct.nhs.uk
Trial website
Contact information
Type
Public
Primary contact
Miss Sandra Robinson
ORCID ID
http://orcid.org/0000-0001-9960-8769
Contact details
Clinical Trials Office
North Tyneside Hospital
North Shields
NE29 8NH
United Kingdom
0191 2934325
sandra.robinson3@nhct.nhs.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
37811, IRAS 189766
Study information
Scientific title
Adherence to Methotrexate in Rheumatoid Arthritis: Effect of an Information Booklet on Methotrexate Levels
Acronym
Study hypothesis
Education with the rheumatoid arthritis information booklet leads to improved methotrexate adherence
Ethics approval
Approved 03/10/2018, South West – Central Bristol Research Ethics Committee (Whitefriars Level 3, Block B, Lewin's Mead, Bristol, BS1 2NT; nrescommittee.southwest-bristol@nhs.net; 0207 104 8028), ref:18/SW/0191
Study design
Interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Rheumatoid arthritis
Intervention
Subjects will be randomised 50:50 to receive the Rheumatoid Arthritis information booklet. Those participants who do not receive the booklet at randomisation will receive it 3 – 6 months later when the participant returns for their routine Methotrexate blood monitoring appointment. The aim of this is to determine whether the intervention of the Rheumatoid Arthritis information booklet has an impact on patient Methotrexate management. All patients will be given the Methotrexate Adherence questionnaire and the RA Questionnaire at screening and again 3 – 6 months later.
A Simple Randomisation Process will be used with an online randomisation tool: Sealed Envelope Ltd 2016
Two study arms, 50% of patients receive an Information Booklet on Rheumatoid Arthritis and Methotrexate and 50% do not receive the booklet at the first meeting. Both groups will be given a Rheumatoid Arthritis Knowledge Questionnaire and a methotrexate Adherence Questionnaire at the first meeting. Both groups will also have their methotrexate levels measured by a blood test at this first meeting. All participants will be followed up 3 – 4 months later, all participants will be asked to repeat the questionnaires and Methotrexate levels will be measure in a blood sample for all patients.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Knowledge of RA measured using the Multiple Choice Rheumatoid Arthritis Questionnaire at the first meeting and the follow up meeting 3 – 4 months later
2. Methotrexate Adherence is measured using Visual Analogue Scales on the Methotrexate Adherence Questionnaire at the first meeting and the follow up meeting 3 – 4 months later.
Secondary outcome measures
Methotrexate levels measured from a blood sample taken from all participants at the first meeting and 3 – 4 months later at the second meeting.
Overall trial start date
13/03/2019
Overall trial end date
01/02/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Subjects capable of giving informed consent in English
2. Male or female
3. Over the age of 18 years
4. Diagnosis of Rheumatoid Arthritis
5. On a stable dose of Methotrexate for at least 3 months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 100; UK Sample Size: 100
Participant exclusion criteria
1. Unwilling or unable to take Methotrexate
2. Unwilling or unable to return for their Methotrexate blood monitoring 3 – 6 months later
3. Unable to read the questionnaires or the Rheumatoid Arthritis booklet
4. Unable to read English
Recruitment start date
18/03/2019
Recruitment end date
01/01/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North Tyneside General Hospital
Rake lane
North Shields
NE29 8NH
United Kingdom
Sponsor information
Organisation
Northumbria healthcare NHS foundation trust
Sponsor details
Rake Lane
North Shields
NE29 8NH
United Kingdom
0191 2934087
Peta.heslop@nhct.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Chugai Pharma Europe Ltd.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The study team plan to present the results of the study at the British Society of Rheumatology Annual Meeting, the study steam also plan to publish the results in a peer reviewed journal of Rheumatology.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
Intention to publish date
01/08/2021
Participant level data
Other
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN14741429_PROTOCOL_20Aug2018.pdf uploaded 08/04/2019