Status:
NOT_YET_RECRUITING
Scintigraphy for Prediction In Rheumatoid Intentional Therapy Tapering
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
The Leeds Teaching Hospitals NHS Trust
Serac Healthcare
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
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...
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 biolog...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT05983848
Start Date
December 1 2024
End Date
December 1 2025
Last Update
October 24 2024
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