99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis
| Status: | Terminated |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/14/2019 |
| Start Date: | September 18, 2017 |
| End Date: | November 12, 2018 |
Phase II Study of 99mTc-rhAnnexin V-128 Radionuclide Imaging in Patients With Clinical Suspicion or Confirmed Diagnosis of Spondyloarthritis (SpA)
Twenty evaluable patients with clinical suspicion or confirmed diagnosis of spondyloarthritis
due to ankylosing spondylitis, or associated with other known clinical conditions like
inflammatory bowel disease, psoriatic arthritis, or undifferentiated spondyloarthropathy.
Five patients will be recruited in the first part of the trial, as a Proof of Concept (PoC)
phase. The PoC phase will assess the imaging potential of 99mTc-rhAnnexin V-128 in terms of
imaging quality, disease-lesion radiotracer uptake and medical relevance to enable the
decision-making to terminate or to continue the clinical investigation completing the
enrollment with the remaining 15 patients.
due to ankylosing spondylitis, or associated with other known clinical conditions like
inflammatory bowel disease, psoriatic arthritis, or undifferentiated spondyloarthropathy.
Five patients will be recruited in the first part of the trial, as a Proof of Concept (PoC)
phase. The PoC phase will assess the imaging potential of 99mTc-rhAnnexin V-128 in terms of
imaging quality, disease-lesion radiotracer uptake and medical relevance to enable the
decision-making to terminate or to continue the clinical investigation completing the
enrollment with the remaining 15 patients.
Inclusion Criteria:
For the first 5 patients enrolled in the POC part:
1. Patients with clinical suspicion or confirmed diagnosis of SpA, based on the ASA
criteria with active symptoms including back, hip or buttock pain prior to:
- A change in NSAID therapy or
- A change in non-biologic DMARD or
- A start of non-biologic DMARD.
For the next 15 patients enrolled in the Phase II part:
1. Patients with clinical suspicion or confirmed diagnosis of SpA, based on the ASAS
criteria with active symptoms including back, hip or buttock pain prior to:
- A change in NSAIDs therapy
- A change in non-biologic DMARD
- A start of non-biologic DMARD
- A start of biologic DMARD
For all patients:
2. Age over 18 years old.
3. Signed Informed Consent Form
Exclusion Criteria:
1. Pregnancy or lactation
2. Liver impairment (ALT, AST or Bilirubin > 2 ULN) at screening visit or baseline
3. Kidney impairment (serum creatinine > 1.5 mg/dL)
4. History of any disease or relevant physical or psychiatric condition or abnormal
physical finding which may interfere with the study objectives at the investigator
judgment
5. Known hypersensitivity to the investigational drug or any of its components
6. Contraindication(s) to the MRI procedure (claustrophobia, prosthetic valve, pacemaker,
inability to lie still in a supine position)
7. Participation to another clinical trial within 4 weeks before study inclusion except
for patients who have participated or who are currently participating in an
interventional study without any study drug administration.
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