Scintigraphy for Prediction In Rheumatoid Intentional Therapy Tapering (SPIRITT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Radiation: 99mMaracticaltide imaging

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 Type: Observational
• Enrollment (Estimated): 86

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

RA patients selected for treatment tapering

Description

Inclusion Criteria:

1. A diagnosis of RA according to American College of Rheumatology/EULAR criteria.
2. Clinical remission or LDA and deemed suitable for treatment tapering by their supervising rheumatologist.
3. Existing TNF inhibitor therapy (adalimumab, etanercept, certolizumab pegol, golimumab, infliximab) administered at doses and dosing intervals that have been stable for ≥ 6 months.
4. Aged between 18 and 80 years of age

Exclusion Criteria:

1. Recently received IM/IA steroids (12 weeks washout required).
2. 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.
3. The subject has known allergies to maraciclatide or any constituent of its injectate.
4. The subject size or weight is not compatible with imaging as determined by the investigator.
5. The subject has received any radiopharmaceutical within 7 days or 10 half-lives prior to the imaging day (Day 0).
6. The subject is pregnant or lactating.
7. The subject has severe renal dysfunction, with estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2.
8. The subject has hepatic insufficiency as demonstrated by ALT (alanine aminotransferase [SGPT]) or AST (aspartate aminotransferase [SGOT]) >3 times the upper limit of normal.
9. 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.
10. 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.
11. Patients who are currently involved in interventional trials will not be suitable

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
99mTc-maraciclatide is predictive of risk of flare	The purpose of this study is to determine whether baseline 99mTc-maraciclatide is predictive of risk of flare in RA patients tapering biologic therapy who are in in low disease activity or remission	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interval and Baseline scan	To determine whether an interval scan alone or in combination with the baseline scan is predictive of flare	12 months
Ultrasound correlation	To determine whether ultrasound (grey scale and power Doppler) correlates with 99mTc-maraciclatide in this patient cohort at the whole patient and individual joint level	12 months
Serological correlation	To determine correlation between 99mTc-maraciclatide imaging and clinical and serological markers of disease activity	12 months

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: The Leeds Teaching Hospitals NHS Trust; Versus Arthritis; Serac Healthcare

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 825832

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No