Scintigraphy for Prediction In Rheumatoid Intentional Therapy Tapering

NCT05983848 | Not Yet Recruiting

• 1 other identifier: 825832
• Study Type: observational
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 99mTc-maraciclatide is predictive of risk of flare

  Number of patients who flare within 12 months which also have increased 99mTc-maraciclatide

  12 months

Secondary Outcomes (3)

• Interval and Baseline scan

  12 months

• Ultrasound correlation

  12 months

• Serological correlation

  12 months

Interventions

99mMaracticaltide imaging RADIATION

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

RA patients selected for treatment tapering

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• The Leeds Teaching Hospitals NHS Trust: collaborator
• Serac Healthcare: collaborator
• Versus Arthritis: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Additional study bloods (20ml) will be taken at baseline and 6-month visits for serological markers of inflammation and neoangiogenesis. Serum samples will be given a trial ID and stored in the Infectious Disease Biobank, King's College London. Samples will be processed, stored and disposed in accordance with all applicable legal and regulatory requirements, including the Human Tissue Act 2004 and any amendments thereafter.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Amy Day, PhD

CONTACT

07393242712; amy.day@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 9, 2023
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share