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99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis

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ClinicalTrials.gov Identifier: NCT03232580
Recruitment Status : Terminated (Sponsor Decision)
First Posted : July 28, 2017
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Advanced Accelerator Applications

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Diagnosis of Spondyloarthritis Drug: rhAnnexin V-128 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase II Study of 99mTc-rhAnnexin V-128 Radionuclide Imaging in Patients With Clinical Suspicion or Confirmed Diagnosis of Spondyloarthritis (SpA)
Actual Study Start Date : September 18, 2017
Actual Primary Completion Date : November 12, 2018
Actual Study Completion Date : November 12, 2018

Arm Intervention/treatment
Experimental: Patients
All patients will receive a single administration of 99mTc-rhAnnexin V-128 at Day 0.
Drug: rhAnnexin V-128
Patients will receive a single administration of 99mTc-rhAnnexin V-128 at Day 0




Primary Outcome Measures :
  1. 99mTc-rhAnnexin V-128 uptake [ Time Frame: 1 Month ]
    uptake compared with background should be assessed for each affected area by nuclear medicine physicians using a 4-grade scoring system (e.g. 0, none; 1, mild or present but < to background uptake; 2, moderate or = to background uptake; 3, intense or > to background uptake).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232580


Locations
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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Advanced Accelerator Applications

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Responsible Party: Advanced Accelerator Applications
ClinicalTrials.gov Identifier: NCT03232580     History of Changes
Other Study ID Numbers: AAA-Annexin-03
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases