ISRCTN13161614Active, not recruitingUnknown
Molecular imaging using 99mTc-maraciclatide for detection of joint inflammation in inflammatory arthritis
niversity of Leeds0 sites68 target enrollmentStarted: July 29, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 68
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Age > = 18 years old
- •2. The participant is able and willing to comply with all study procedures as described in the protocol
- •3. Is capable of understanding and signing an informed consent form
- •4. Prior diagnosis of Rheumatoid Arthritis (RA) as determined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria; or prior diagnosis of PsA according to the CASPAR criteria
- •5. Low, moderate or high disease activity as determined by DAS28 score (RA) or DAPSA score (PsA). Individuals in remission, as determined by DAS28 or DAPSA, will not be included.
Exclusion Criteria
- •1. The participant size or body mass is not compatible with imaging as determined by the investigator
- •2. The participant has a known allergy to or has had an adverse reaction to any components or excipients of Maraciclatide (99mTc) Injection
- •3. The participant is pregnant or currently breastfeeding, and are unwilling to stop breastfeeding for a minimum of 12 hours after the Maraciclatide (99mTc) Imaging visit
- •4. The participant has any severe, acute, or chronic medical conditions and/or psychiatric conditions and/or laboratory abnormalities that would impart, in the judgment of the investigator, excess risk associated with any of the study procedures that would deem the participant inappropriate for study participation
- •5. Participant with severe renal disease (eGFR < 45 ml/min/1.73m2) or acutely deteriorating renal function, who would be at risk of nephrogenic systemic fibrosis
- •6. The participant has hepatic insufficiency as demonstrated by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of > 3 times the upper limit of normal
- •7. The participant has a known allergy or previous anaphylactic reaction to a gadolinium-based contrast agent
- •8. The participant has: a pacemaker, surgical clips within the head*, certain inner ear implants, or neuro-electrical stimulators or metal fragments within the eye or head
- •9. The participant has any other known contraindication, in the opinion of the investigator, to contrast-enhanced MRI imaging
- •10. The participant that has one of the following joints unavailable for imaging (e.g. due to injury, joint-replacement, or missing joints): shoulder, wrist, MCP, PIP, knee, ankle, MTP
- •11. The participant has received any radiopharmaceutical within 7 days or 10 half-lives before screening
- •12. The participant has received intramuscular or intravenous steroids < = 4 weeks before screening
- •13. The participant has received intra-articular corticosteroid injections < = 4 weeks before screening
- •14. The participant has a known inability to manage pain effectively with alternative forms of analgesia to NSAIDs (e.g. Paracetamol, Codeine)
- •*X-ray may be requested if there is a need to confirm/exclude the presence of surgical clips or metal fragments in the eye/head.
Investigators
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