Status:
TERMINATED
99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis
Lead Sponsor:
Advanced Accelerator Applications
Conditions:
Spondyloarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This single center, open-label, proof of concept (PoC) Phase II study aimed to assess the investigational imaging agent 99mTc-rhAnnexin V-128 in detecting spondyloarthritis (SpA) lesions. Overall, it...
Detailed Description
The study was prematurely terminated by the sponsor after the first 5 patients completed the PoC phase based on strategic considerations. Novartis acquired Advanced Accelerator Applications SA.
Eligibility Criteria
Inclusion
- 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:
- 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:
- Age over 18 years old.
- Signed Informed Consent Form
Exclusion
- Pregnancy or lactation
- Liver impairment (ALT, AST or Bilirubin \> 2 ULN) at screening visit or baseline
- Kidney impairment (serum creatinine \> 1.5 mg/dL)
- 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
- Known hypersensitivity to the investigational drug or any of its components
- Contraindication(s) to the MRI procedure (claustrophobia, prosthetic valve, pacemaker, inability to lie still in a supine position)
- 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.
Key Trial Info
Start Date :
September 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03232580
Start Date
September 18 2017
End Date
November 12 2018
Last Update
December 13 2019
Active Locations (1)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048