Whole-body imaging using 99mTc-Maraciclatide for rheumatoid and psoriatic arthritis Musculoskeletal Diseases
Conditions
Interventions
STUDY DESIGN: Cross-sectional Observational Imaging Study. This study includes a maximum of four research visits. All visits will occur at Leeds Teaching Hospitals Trust, Chapel Allerton Hospital or S
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Individual site (enthesis/tendon/joint) inflammation (synovitis) measured by 99mTc-Maraciclatide present Y/N (0 absent, 1 present) at one time point | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed at one time point: 1. Individual joint inflammation RAMRIS synovitis score measured using contrast-enhanced MRI (0-3) (MCPs and wrist joints only) 2. Individual site (enthesis/tendon/joint) inflammation (synovitis) measured using contrast-enhanced MRI (0-2) 3. Total entheseal inflammation count measured using contrast-enhanced MRI (0-10) 4. Total tendon inflammation count measured using contrast-enhanced MRI (0-10) 5. Small joint inflammation (synovitis) count measured using contrast-enhanced MRI (0-32) 6. Total joint inflammation (synovitis) count measured using contrast-enhanced MRI (0-38) 7. Individual site (enthesis/tendon/joint) inflammation (synovitis) score measured using PDUS (0-3) 8. Individual site (enthesis/tendon/joint) inflammation (synovitis) measured using PDUS present Y/N (0=0 absent, >0=1 present) 9. Total entheseal inflammation count measured using PDUS (0-10) 10. Total tendon inflammation count measured using PDUS (0-26) 11. Small joint inflammation (synovitis) count measured using PDUS (0-32) 12. Total joint inflammation (synovitis) count measured using PDUS (0-38) 13. Total extra-joint inflammation count measured using 99mTc-Maraciclatide uptake in sites co-located with entheses (0-10) 14. Total extra-joint inflammation count measured using 99mTc-Maraciclatide uptake in sites co-located with tendons (0-20) 15. Small joint inflammation (synovitis) count measured using 99mTc-Maraciclatide uptake (0-32) 16. Total joint inflammation (synovitis) count measured using 99mTc-Maraciclatide uptake (0-38) 17. (Optional) Individual joint inflammation (synovitis) score measured using histopathology (0-9) 18. (Optional) Individual joint inflammation (synovitis) measured using histopathology present Y/N (0-1 negative; 2-9 positive) 19. Health status measured using the Health Assessment Questionnaire Disability Index (HAQ-DI) (0-3) and participant completed general health VAS (0-100) 20. Physician assessment | — |
Countries
England, United Kingdom
Outcome results
None listed