Rheumatoid ArthritisTAPERNCT04429776
Tapering of Biologics in Inflammatory Arthritis Patients in Remission
A study testing Drug level testing with feedback provided and Drug level testing with no feedback provided in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by University of Manchester at 1 site in United Kingdom.
Trial summary
Rheumatoid arthritis (RA) and Psoriatic Arthritis (PsA) are types of inflammatory arthritis. They are disabling conditions caused by inflammation in joints that can lead to pain, stiffness, fatigue and joint damage. There is currently no cure but treatment is aimed at reducing joint inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis
- What is being tested?
- Drug level testing with feedback provided and Drug level testing with no feedback provided
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 May 2021to 31 Dec 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have RA according to the American College of Rheumatology (ACR) 1987 or 2010 criteria
- Patients must be willing and able to participate in the study (including follow up visits and providing blood samples) after providing informed consent.
- Patients must currently be on stable treatment a one of the following single anti-TNF agents Adalimumab, Etanercept or Certolizumab. They must have been taking this biologic/ biosimilar therapy for a minimum of 12 months
- Patients must be in remission with a DAS28 CRP of less than or equal to 2.6.
- A DAS28 score must be provided at baseline. This must have been taken within the month before study recruitment. If this DAS score is not available, the patient is not eligible to take part.
- Consultant must be looking to taper patient's standard care medication
- Aged 18 years or over
Who cannot join
- Anyone who has switched anti-TNF agent in the last 12 months
- Anyone without a recent DAS score (within the previous month)
- Anyone taking any anti-TNF therapy that isn't Adalimumab, Etanercept or Certolizumab.
- Anyone who has received steroids within past 3 months (enteral, parenteral or intra-articular)
- Anyone who is currently pregnancy, or pregnancy planned within next 6 months
- Anyone with any planned major surgery
- Anyone with the inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University Hospitals NHS Foundation Trust
Manchester, North West, M13 9WL
About this study
Rheumatoid arthritis (RA) and Psoriatic Arthritis (PsA) are types of inflammatory arthritis. They are disabling conditions caused by inflammation in joints that can lead to pain, stiffness, fatigue and joint damage. There is currently no cure but treatment is aimed at reducing joint inflammation. Some of the most promising new therapies work by interfering with the binding of a molecule called tumour necrosis factor (TNF). In recent years, new anti-TNF drugs (such as adalimumab, etanercept and certolizumab) have been developed that block the action of TNF and reduce this inflammation. These drugs are very effective in controlling inflammation for many patients whose arthritis has not responded to other therapies. Some patients can take these medications for a long time. If a patient is stable on their rheumatoid arthritis biologic or biosimilar, tapering the drug is often considered.
The investigators are planning to look at drug level and anti-drug antibody testing to guide anti-TNF tapering (reducing) decisions in UK patients with RA who have stable, reduced arthritis symptoms. The investigators think that measuring these drug levels and anti-drug antibodies in blood samples will be useful for guiding this process, but the investigators can't be sure. It is important to do this safely so the patient doesn't experience a flare of their disease symptoms. The study will be used to determine whether a much larger study to assess the usefulness of these measurements would be achievable.
Read more
This study will assess whether measuring biomarkers (measurable substances in the blood) that may affect a patient's response to treatment.
If a patient are eligible to take part, they will be randomly allocated to one of the following groups;
- Their Doctor receiving information and treatment advice based on their blood results or
- Their Doctor not receiving this information
Read the detailed description
Participants will be randomly allocated to feedback of their drug levels / antidrug antibody status to their consultant prior to tapering, or not, in a 1:1 ratio.
- Those participants randomised to the group where no feedback is required will have their dosing interval doubled (from 2 to 4 weeks for certolizumab and adalimumab; from 1 to 2 weeks for etanercept).
- For participants randomised to the arm where results are received by the treating clinician, advice will accompany the results. It will be made clear that this is advice only and that the ultimate treatment decisions rest with the treating clinician.
Patients would be recruited at the point at which the decision is made to begin tapering their biologic.
The NHS site teams will be informed which arm of the study the participant has been randomised to, as they will be made aware of patient test results. Participants will not be blinded to which intervention they receive. University of Manchester Researchers undertaking the laboratory tests and those entering study data will be blinded.
The consent form, registration form, baseline CRF and baseline participant questionnaire should then be returned to the study coordinator at CfMR in the pre-paid packaging provided.
A baseline DAS28 score must be provided. This should be from no more than a month before the date of consent. If this cannot be provided the patient is not eligible to take part.
Recruiting teams can start to taper the patient's medication immediately after consent on to the TAPER trial.
Blood samples will be taken at the following time points;
- Baseline (at the point of consent, when the decision to taper is made)
- 6 months after tapering starts
- 12 months after tapering starts Participants in TAPER will need to have their blood samples taken the day before their next anti-TNF injection date. This means the participant will have to come in to their hospital sites at these time points for their sample. Sites will be provided with blood kits for this. These will include a phlebotomy letter, just in case the participant needs to go to a different hospital department to have their bloods taken. These will be returned to the University of Manchester is the pre-paid postage boxes provided.
The researchers would like each of the follow-up visits to occur as closely to the 6 month and 12 month time points as possible. However, the researchers will accept the following visit windows;
- 6 and 12 month time points; +/- 1 month The University of Manchester will return the blood results to site for participants randomised to the arm where results are returned. This will be sent via email with appropriate treatment advice, as per the information in section 4 within 4 weeks of sample receipt. The site team will receive these results by letter in advance of the follow-up visit and will have the opportunity to discuss these with the Chief Investigator, Prof. Anne Barton, in advance of the visit if required. For participants in the control arm (no feedback of results), the blood samples will be collected and tested in the same way but results will not be provided to the treating clinician.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis
- Being tested
- Drug level testing with feedback provided, Drug level testing with no feedback provided
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug level testing with feedback providedDiagnostic test
Also called Anti-drug antibody testing
Feedback about drug levels in blood provided to participant's site
Drug level testing with no feedback providedDiagnostic test
Also called Anti-drug antibody testing
Testing drug levels in blood but feedback not provided to participant's site
| Study group | Role | What they receive |
|---|---|---|
| Feedback Arm | Experimental | Trough blood samples taken and analysed at baseline, 6m and 12m. Results fed back to recruiting clinical team who can choose to use these to influence their tapering decisions. Receives: Diagnostic Test: Drug level testing with feedback provided |
| No Feedback Arm | Active comparator | Trough blood samples taken and analysed at baseline, 6m and 12m. Results not fed back to recruiting clinical team. Receives: Diagnostic Test: Drug level testing with no feedback provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to flare
Time to flare
Measured: 3 years
Secondary outcomes (5)
Successful recruitment
Successful recruitment
Measured: 3 years
Was biologic advice, provided in the protocol, adopted by clinicians and participants?
Adoption of biologic advice by clinicians and participants; assessed by end of study questionnaires
Measured: 3 years
Participant withdrawal rate
Participant withdrawal rate
Measured: 3 years
Participant acceptability, via the feedback form
Participant acceptability, via the feedback form
Measured: 3 years
Participant reported outcome measures recorded in the participant questionnaire booklet.
Participant reported outcome measures recorded in the participant questionnaire booklet.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start13 May 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 ManchesterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 50 Participants: randomised 1:1 to either feedback of test results to treating clinician or no feedback to treating clinician (25 participants each arm)
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Barton, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429776
- Sponsor's protocol ID
- 281569
- Acronym
- TAPER
- Status last verified
- May 2024
- First submitted
- 5 Jun 2020
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tapering of Biologics in Inflammatory Arthritis Patients in Remission
- ClinicalTrials.gov ID
- NCT04429776
- Acronym / sponsor ID
- TAPER / 281569
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 13 May 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Jun 2020 (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.
Rheumatoid arthritis (RA) and Psoriatic Arthritis (PsA) are types of inflammatory arthritis. They are disabling conditions caused by inflammation in joints that can lead to pain, stiffness, fatigue and joint damage. There is currently no cure but treatment is aimed at reducing joint inflammation. Some of the most promising new therapies work by interfering with the binding of a molecule called tumour necrosis factor (TNF). In recent years, new anti-TNF drugs (such as adalimumab, etanercept and certolizumab) have been developed that block the action of TNF and reduce this inflammation. These drugs are very effective in controlling inflammation for many patients whose arthritis has not responded to other therapies. Some patients can take these medications for a long time. If a patient is stable on their rheumatoid arthritis biologic or biosimilar, tapering the drug is often considered.
The investigators are planning to look at drug level and anti-drug antibody testing to guide anti-TNF tapering (reducing) decisions in UK patients with RA who have stable, reduced arthritis symptoms. The investigators think that measuring these drug levels and anti-drug antibodies in blood samples will be useful for guiding this process, but the investigators can't be sure. It is important to do this safely so the patient doesn't experience a flare of their disease symptoms. The study will be used to determine whether a much larger study to assess the usefulness of these measurements would be achievable.
This study will assess whether measuring biomarkers (measurable substances in the blood) that may affect a patient's response to treatment.
If a patient are eligible to take part, they will be randomly allocated to one of the following groups;
- Their Doctor receiving information and treatment advice based on their blood results or
- Their Doctor not receiving this information
Detailed description
Participants will be randomly allocated to feedback of their drug levels / antidrug antibody status to their consultant prior to tapering, or not, in a 1:1 ratio.
- Those participants randomised to the group where no feedback is required will have their dosing interval doubled (from 2 to 4 weeks for certolizumab and adalimumab; from 1 to 2 weeks for etanercept).
- For participants randomised to the arm where results are received by the treating clinician, advice will accompany the results. It will be made clear that this is advice only and that the ultimate treatment decisions rest with the treating clinician.
Patients would be recruited at the point at which the decision is made to begin tapering their biologic.
The NHS site teams will be informed which arm of the study the participant has been randomised to, as they will be made aware of patient test results. Participants will not be blinded to which intervention they receive. University of Manchester Researchers undertaking the laboratory tests and those entering study data will be blinded.
The consent form, registration form, baseline CRF and baseline participant questionnaire should then be returned to the study coordinator at CfMR in the pre-paid packaging provided.
A baseline DAS28 score must be provided. This should be from no more than a month before the date of consent. If this cannot be provided the patient is not eligible to take part.
Recruiting teams can start to taper the patient's medication immediately after consent on to the TAPER trial.
Blood samples will be taken at the following time points;
- Baseline (at the point of consent, when the decision to taper is made)
- 6 months after tapering starts
- 12 months after tapering starts Participants in TAPER will need to have their blood samples taken the day before their next anti-TNF injection date. This means the participant will have to come in to their hospital sites at these time points for their sample. Sites will be provided with blood kits for this. These will include a phlebotomy letter, just in case the participant needs to go to a different hospital department to have their bloods taken. These will be returned to the University of Manchester is the pre-paid postage boxes provided.
The researchers would like each of the follow-up visits to occur as closely to the 6 month and 12 month time points as possible. However, the researchers will accept the following visit windows;
- 6 and 12 month time points; +/- 1 month The University of Manchester will return the blood results to site for participants randomised to the arm where results are returned. This will be sent via email with appropriate treatment advice, as per the information in section 4 within 4 weeks of sample receipt. The site team will receive these results by letter in advance of the follow-up visit and will have the opportunity to discuss these with the Chief Investigator, Prof. Anne Barton, in advance of the visit if required. For participants in the control arm (no feedback of results), the blood samples will be collected and tested in the same way but results will not be provided to the treating clinician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 50 Participants: randomised 1:1 to either feedback of test results to treating clinician or no feedback to treating clinician (25 participants each arm)
| Arm | Type | Receives |
|---|---|---|
| Feedback Arm | Experimental | Diagnostic Test: Drug level testing with feedback providedTrough blood samples taken and analysed at baseline, 6m and 12m. Results fed back to recruiting clinical team who can choose to use these to influence their tapering decisions. |
| No Feedback Arm | Active comparator | Diagnostic Test: Drug level testing with no feedback providedTrough blood samples taken and analysed at baseline, 6m and 12m. Results not fed back to recruiting clinical team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have RA according to the American College of Rheumatology (ACR) 1987 or 2010 criteria
- Patients must be willing and able to participate in the study (including follow up visits and providing blood samples) after providing informed consent.
- Patients must currently be on stable treatment a one of the following single anti-TNF agents Adalimumab, Etanercept or Certolizumab. They must have been taking this biologic/ biosimilar therapy for a minimum of 12 months
- Patients must be in remission with a DAS28 CRP of less than or equal to 2.6.
- A DAS28 score must be provided at baseline. This must have been taken within the month before study recruitment. If this DAS score is not available, the patient is not eligible to take part.
Key exclusion criteria (7 listed)
- Anyone who has switched anti-TNF agent in the last 12 months
- Anyone without a recent DAS score (within the previous month)
- Anyone taking any anti-TNF therapy that isn't Adalimumab, Etanercept or Certolizumab.
- Anyone who has received steroids within past 3 months (enteral, parenteral or intra-articular)
- Anyone who is currently pregnancy, or pregnancy planned within next 6 months
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 |
|---|---|---|
| Drug level testing with feedback providedAlso: Anti-drug antibody testingFeedback about drug levels in blood provided to participant's site | Diagnostic test | Feedback Arm |
| Drug level testing with no feedback providedAlso: Anti-drug antibody testingTesting drug levels in blood but feedback not provided to participant's site | Diagnostic test | No Feedback Arm |
Primary outcome
Time to flare
Time frame: 3 years
Time to flare
5 secondary outcomes
Successful recruitment
Time frame: 3 years
Was biologic advice, provided in the protocol, adopted by clinicians and participants?
Time frame: 3 years
Participant withdrawal rate
Time frame: 3 years
Participant acceptability, via the feedback form
Time frame: 3 years
Participant reported outcome measures recorded in the participant questionnaire booklet.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug level testing with feedback provided and Drug level testing with no feedback provided in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by University of Manchester 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 May 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?
Results are not available in the source record.
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?
Time to flare (time frame: 3 years). 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 10 May 2024.