Rheumatoid ArthritisSPIRITTNCT05983848
Scintigraphy for Prediction In Rheumatoid Intentional Therapy Tapering
An observational study of Rheumatoid Arthritis, run by Guy's and St Thomas' NHS Foundation Trust.
Trial summary
The goal of this observational study is to investigate whether 99mTc-maraciclatide imaging prior to biologic therapy tapering and after 3 months can predict those at risk of Rheumatoid arthritis flare. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- 99mMaracticaltide imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Dec 2025
- 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 80 years
- All sexes
- Adult, Older adult
Study population: RA patients selected for treatment tapering
Who may be able to join
- A diagnosis of RA according to American College of Rheumatology/EULAR criteria.
- Clinical remission or LDA and deemed suitable for treatment tapering by their supervising rheumatologist.
- Existing TNF inhibitor therapy (adalimumab, etanercept, certolizumab pegol, golimumab, infliximab) administered at doses and dosing intervals that have been stable for ≥ 6 months.
- Aged between 18 and 80 years of age
Who cannot join
- Recently received IM/IA steroids (12 weeks washout required).
- The subject was previously entered into this study or has participated in any other investigational drug or medical device study within 30 days of enrolment.
- The subject has known allergies to maraciclatide or any constituent of its injectate.
- The subject size or weight is not compatible with imaging as determined by the investigator.
- The subject has received any radiopharmaceutical within 7 days or 10 half-lives prior to the imaging day (Day 0).
- The subject is pregnant or lactating.
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- The subject has severe renal dysfunction, with estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2.
- The subject has hepatic insufficiency as demonstrated by ALT (alanine aminotransferase [SGPT]) or AST (aspartate aminotransferase [SGOT]) >3 times the upper limit of normal.
- The subject presents with any other clinically active, serious, life-threatening disease with a life expectancy of less than 12 months or where participation in the study might compromise the management of the subject or other reason that in the judgment of the investigator(s) makes the subject unsuitable for participation in the study.
- The subject is claustrophobic or has a movement disorder that prevents him/her from lying still in a supine position for up to 20 minutes at a time.
- Patients who are currently involved in interventional trials will not be suitable
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Observational Study Exploring the Value 99mMaracticaltide Imaging for Predicting Outcomes for Patients With Rheumatoid Arthritis Undergoing Tapering of Therapy
The goal of this observational study is to investigate whether 99mTc-maraciclatide imaging prior to biologic therapy tapering and after 3 months can predict those at risk of Rheumatoid arthritis flare.
Participants undergoing routine tapering of biologic drug therapy will have 99mTc-maraciclatide imaging in addition to normal ultrasound imaging and then followed up over 12 months to assess whether an interval scan alone or in combination with the baseline scan is predictive of flare.
Read the detailed description
Rheumatoid arthritis is a chronic inflammatory condition affecting the joints which over time can cause progressive arthritis and disability. Since the introduction of widespread us of targeted biologic therapies. More patients are now maintained in remission and low disease activity with better long-term outcomes. Making treatment decisions can be challenging as disease activity scores do not always reflect inflammatory disease activity and active inflammation may be present but not manifested by clinically obvious swelling. Ultrasound, and in particular power Doppler (PD), has been shown to be a more sensitive indicator of active inflammatory disease and is widely used in clinical practice to inform decision making.
However, ultrasound is time consuming and thus expensive and it is impractical to image more than a few joints routinely. We have shown that 99mTc-maraciclatide, a nuclear imaging agent that uses equipment routinely available in hospitals, correlates with PD and hence has potential as an accessible, more cost effective and, as is has the potential to image all the joints in a single acquisition, more clinically informative alternative.
Many patients on biologic therapy achieve low disease activity and may be suitable for tapering of medication. This has the advantage of reducing exposure to immunosuppressive medication and reducing costs. Whilst many patients can be tapered safely it is not always clear who is at risk of flaring. It is known that the presence of PD signal can predict higher risk, but this is not routinely used in practice for the reasons above. In this study we will investigate whether 99mTc-maraciclatide imaging prior to tapering and after 3 months can predict those at risk of flare. Success will indicate that it could be used in clinical practice with potential to minimise exposure to unnecessary treatment whilst preserving clinical outcomes, improving patient experience and reducing costs.
- Conditions
- Rheumatoid Arthritis
- Being tested
- 99mMaracticaltide imaging
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mMaracticaltide imagingRadiation
7.3.1 99mTc-maraciclatide imaging This will be undertaken at baseline and optionally at 8-12 weeks. Not more than 75 µg of 99mTc-maraciclatide will be administered intravenously with an activity as close as possible to 740 MBq. Static whole-body imaging will be undertaken after a maximum of 2 hours with further dedicated views of the hands and feet. Total image acquisition time will be approximately 30 minutes. Images will be scored by quantitative and semi-quantitative methods by a blinded observer.
What is being measured
The primary outcome is the main question the study is designed to answer.
99mTc-maraciclatide is predictive of risk of flare
Number of patients who flare within 12 months which also have increased 99mTc-maraciclatide
Measured: 12 months
Secondary outcomes (3)
Interval and Baseline scan
Correlations between interval scan scoring alone or in combination with the baseline scan scoring and incidence of flare
Measured: 12 months
Ultrasound correlation
Correlation between ultrasound (grey scale and power Doppler) and 99mTc-maraciclatide scoring at the whole patient and individual joint level
Measured: 12 months
Serological correlation
Correlation between 99mTc-maraciclatide imaging and clinical and serological markers of disease activity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (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 Guy's and St Thomas' NHS Foundation TrustThe 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
- Cross-sectional
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust, Serac Healthcare, Versus Arthritis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983848
- Sponsor's protocol ID
- 825832
- Acronym
- SPIRITT
- Status last verified
- Oct 2024
- First submitted
- 2 Aug 2023
- Last updated
- 24 Oct 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 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Exploring the Value 99mMaracticaltide Imaging for Predicting Outcomes for Patients With Rheumatoid Arthritis Undergoing Tapering of Therapy
- ClinicalTrials.gov ID
- NCT05983848
- Acronym / sponsor ID
- SPIRITT / 825832
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust, Serac Healthcare, Versus Arthritis
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Aug 2023 (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.
The goal of this observational study is to investigate whether 99mTc-maraciclatide imaging prior to biologic therapy tapering and after 3 months can predict those at risk of Rheumatoid arthritis flare.
Participants undergoing routine tapering of biologic drug therapy will have 99mTc-maraciclatide imaging in addition to normal ultrasound imaging and then followed up over 12 months to assess whether an interval scan alone or in combination with the baseline scan is predictive of flare.
Detailed description
Rheumatoid arthritis is a chronic inflammatory condition affecting the joints which over time can cause progressive arthritis and disability. Since the introduction of widespread us of targeted biologic therapies. More patients are now maintained in remission and low disease activity with better long-term outcomes. Making treatment decisions can be challenging as disease activity scores do not always reflect inflammatory disease activity and active inflammation may be present but not manifested by clinically obvious swelling. Ultrasound, and in particular power Doppler (PD), has been shown to be a more sensitive indicator of active inflammatory disease and is widely used in clinical practice to inform decision making.
However, ultrasound is time consuming and thus expensive and it is impractical to image more than a few joints routinely. We have shown that 99mTc-maraciclatide, a nuclear imaging agent that uses equipment routinely available in hospitals, correlates with PD and hence has potential as an accessible, more cost effective and, as is has the potential to image all the joints in a single acquisition, more clinically informative alternative.
Many patients on biologic therapy achieve low disease activity and may be suitable for tapering of medication. This has the advantage of reducing exposure to immunosuppressive medication and reducing costs. Whilst many patients can be tapered safely it is not always clear who is at risk of flaring. It is known that the presence of PD signal can predict higher risk, but this is not routinely used in practice for the reasons above. In this study we will investigate whether 99mTc-maraciclatide imaging prior to tapering and after 3 months can predict those at risk of flare. Success will indicate that it could be used in clinical practice with potential to minimise exposure to unnecessary treatment whilst preserving clinical outcomes, improving patient experience and reducing costs.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- RA patients selected for treatment tapering
Key inclusion criteria (4 listed)
- A diagnosis of RA according to American College of Rheumatology/EULAR criteria.
- Clinical remission or LDA and deemed suitable for treatment tapering by their supervising rheumatologist.
- Existing TNF inhibitor therapy (adalimumab, etanercept, certolizumab pegol, golimumab, infliximab) administered at doses and dosing intervals that have been stable for ≥ 6 months.
- Aged between 18 and 80 years of age
Key exclusion criteria (11 listed)
- Recently received IM/IA steroids (12 weeks washout required).
- The subject was previously entered into this study or has participated in any other investigational drug or medical device study within 30 days of enrolment.
- The subject has known allergies to maraciclatide or any constituent of its injectate.
- The subject size or weight is not compatible with imaging as determined by the investigator.
- The subject has received any radiopharmaceutical within 7 days or 10 half-lives prior to the imaging day (Day 0).
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 |
|---|---|---|
| 99mMaracticaltide imaging7.3.1 99mTc-maraciclatide imaging This will be undertaken at baseline and optionally at 8-12 weeks. Not more than 75 µg of 99mTc-maraciclatide will be administered intravenously with an activity as close as possible to 740 MBq. Static whole-body imaging will be undertaken after a maximum of 2 hours with further dedicated views of the hands and feet. Total image acquisition time will be approximately 30 minutes. Images will be scored by quantitative and semi-quantitative methods by a blinded observer. | Radiation | – |
Primary outcome
99mTc-maraciclatide is predictive of risk of flare
Time frame: 12 months
Number of patients who flare within 12 months which also have increased 99mTc-maraciclatide
3 secondary outcomes
Interval and Baseline scan
Time frame: 12 months
Ultrasound correlation
Time frame: 12 months
Serological correlation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Guy's and St Thomas' NHS Foundation Trust.
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 11 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 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Amy Day, PhD (07393242712, amy.day@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
99mTc-maraciclatide is predictive of risk of flare (time frame: 12 months). 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 24 Oct 2024.