Back to results99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis (Annexin 03)
Primary Purpose
Spondyloarthritis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rhAnnexin V-128
Sponsored by
About this trial
This is an interventional diagnostic trial for Spondyloarthritis focused on measuring Suspicion or confirmed diagnosis of Spondyloarthritis, Ankylosing Spondylarthritis, Ankylosing Spondylitis, Ankylosing Spondyloarthritis, Rheumatoid Spondylitis, Spondylarthritis Ankylopoietica, Spondylitis Ankylopoietica, Spondyloarthritis Ankylopoietica, Autoimmune systemic rheumatic disease, Inflammatory bowel disease, Psoriatic arthritis, Undifferentiated spondyloarthropathy.
Eligibility 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:
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 Criteria:
- 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.
Sites / Locations
- Cedars Sinai Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rhAnnexin V-128
Arm Description
All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.
Outcomes
Primary Outcome Measures
99mTc-rhAnnexin V-128 Uptake
In order to asses 99mTc-rhAnnexin V-128 magnitude and dynamic range of uptake within areas affected by inflammation, Single-Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT) scans were interpreted and graded by at least two independent experienced nuclear medicine physicians blinded from clinical data and other imagings modality results.
Uptake compared with background (e.g. physiological liver uptake) were 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). Only descriptive analysis performed.
99mTc-rhAnnexin V-128 Uptake Adjudication
In order to asses 99mTc-rhAnnexin V-128 magnitude and dynamic range of uptake within areas affected by inflammation, Single-Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT) scans were interpreted and graded by at least two independent experienced nuclear medicine physicians blinded from clinical data and other imagings modality results.
In case of discrepancies between the different readers, an adjudication process based on consensus was put in place in order to obtain one final outcome for each area. Adjudication results were categorized as Positive or Negative. Only descriptive analysis performed.
Secondary Outcome Measures
Full Information
NCT ID
NCT03232580
First Posted
July 13, 2017
Last Updated
December 12, 2019
Sponsor
Advanced Accelerator Applications
1. Study Identification
Unique Protocol Identification Number
NCT03232580
Brief Title
99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis
Acronym
Annexin 03
Official Title
Phase II Study of 99mTc-rhAnnexin V-128 Radionuclide Imaging in Patients With Clinical Suspicion or Confirmed Diagnosis of Spondyloarthritis (SpA)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor Decision based on strategic considerations.
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
November 12, 2018 (Actual)
Study Completion Date
November 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Accelerator Applications
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 was planned to recruit 20 adults with suspected or confirmed SpA. First, 5 patients were enrolled into a "proof of concept" phase, to assess the imaging potential of 99mTc-rhAnnexin V-128 in terms of imaging quality, disease-lesion radiotracer uptake and medical relevance. Based on these results the Data Monitoring Committee (DMC) was to decide whether to terminate the study or whether to continue and enroll the next 15 planned patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis
Keywords
Suspicion or confirmed diagnosis of Spondyloarthritis, Ankylosing Spondylarthritis, Ankylosing Spondylitis, Ankylosing Spondyloarthritis, Rheumatoid Spondylitis, Spondylarthritis Ankylopoietica, Spondylitis Ankylopoietica, Spondyloarthritis Ankylopoietica, Autoimmune systemic rheumatic disease, Inflammatory bowel disease, Psoriatic arthritis, Undifferentiated spondyloarthropathy.
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rhAnnexin V-128
Arm Type
Experimental
Arm Description
All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.
Intervention Type
Drug
Intervention Name(s)
rhAnnexin V-128
Intervention Description
All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.
Primary Outcome Measure Information:
Title
99mTc-rhAnnexin V-128 Uptake
Description
In order to asses 99mTc-rhAnnexin V-128 magnitude and dynamic range of uptake within areas affected by inflammation, Single-Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT) scans were interpreted and graded by at least two independent experienced nuclear medicine physicians blinded from clinical data and other imagings modality results.
Uptake compared with background (e.g. physiological liver uptake) were 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). Only descriptive analysis performed.
Time Frame
60 minutes and 120 minutes post investigational product adminstration
Title
99mTc-rhAnnexin V-128 Uptake Adjudication
Description
In order to asses 99mTc-rhAnnexin V-128 magnitude and dynamic range of uptake within areas affected by inflammation, Single-Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT) scans were interpreted and graded by at least two independent experienced nuclear medicine physicians blinded from clinical data and other imagings modality results.
In case of discrepancies between the different readers, an adjudication process based on consensus was put in place in order to obtain one final outcome for each area. Adjudication results were categorized as Positive or Negative. Only descriptive analysis performed.
Time Frame
60 minutes and 120 minutes post investigational product adminstration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Learn more about this trial
99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis
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