Spondyloarthritis
Conditions
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.
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.
Interventions
DRUGrhAnnexin V-128
All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.
Sponsors
Advanced Accelerator Applications
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 99mTc-rhAnnexin V-128 Uptake | 60 minutes and 120 minutes post investigational product adminstration | 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 | 60 minutes and 120 minutes post investigational product adminstration | 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. |
Countries
United States
Participant flow
Recruitment details
5 patients enrolled single site in US
Participants by arm
| Arm | Count |
|---|---|
| rhAnnexin V-128 All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | rhAnnexin V-128 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Participants with Clinical Pain at Screening Clinical Pain in Lumbar Spine No | 0 Participants |
| Participants with Clinical Pain at Screening Clinical Pain in Lumbar Spine Yes | 5 Participants |
| Participants with Clinical Pain at Screening Clinical Pain in Sacroiliac Joints No | 0 Participants |
| Participants with Clinical Pain at Screening Clinical Pain in Sacroiliac Joints Yes | 5 Participants |
| Participants with Magnetic Resonance Imaging (MRI) results at Screening MRI Results in Lumbar Spine Negative | 4 Participants |
| Participants with Magnetic Resonance Imaging (MRI) results at Screening MRI Results in Lumbar Spine Positive | 1 Participants |
| Participants with Magnetic Resonance Imaging (MRI) results at Screening MRI Results in Sacroiliac Joints Negative | 4 Participants |
| Participants with Magnetic Resonance Imaging (MRI) results at Screening MRI Results in Sacroiliac Joints Positive | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 2 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
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.
Time frame: 60 minutes and 120 minutes post investigational product adminstration
Population: Only participants with a grading uptake at any given body region are included in the analysis
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Abdomen - Reviewer 1 | Grade of uptake = 2 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Whole Body Planar - Principal Inv. | Grade of uptake = 0 | 2 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Whole Body Planar - Principal Inv. | Grade of uptake = 1 | 1 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Whole Body Planar - Principal Inv. | Grade of uptake = 2 | 2 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Whole Body Planar - Principal Inv. | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Whole Body Planar - Reviewer 1 | Grade of uptake = 0 | 5 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Whole Body Planar - Reviewer 1 | Grade of uptake = 1 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Whole Body Planar - Reviewer 1 | Grade of uptake = 2 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Whole Body Planar - Reviewer 1 | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Whole Body Planar - Reviewer 2 | Grade of uptake = 0 | 3 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Whole Body Planar - Reviewer 2 | Grade of uptake = 1 | 2 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Whole Body Planar - Reviewer 2 | Grade of uptake = 2 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Abdomen - Reviewer 1 | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Abdomen - Reviewer 2 | Grade of uptake = 0 | 5 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Whole Body Planar - Reviewer 2 | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Whole Body Planar - Principal Inv. | Grade of uptake = 0 | 1 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Whole Body Planar - Principal Inv. | Grade of uptake = 1 | 2 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Whole Body Planar - Principal Inv. | Grade of uptake = 2 | 1 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Whole Body Planar - Principal Inv. | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Whole Body Planar - Reviewer 1 | Grade of uptake = 0 | 5 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Whole Body Planar - Reviewer 1 | Grade of uptake = 1 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Whole Body Planar - Reviewer 1 | Grade of uptake = 2 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Whole Body Planar - Reviewer 1 | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Whole Body Planar - Reviewer 2 | Grade of uptake = 0 | 3 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Whole Body Planar - Reviewer 2 | Grade of uptake = 1 | 2 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Whole Body Planar - Reviewer 2 | Grade of uptake = 2 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Whole Body Planar - Reviewer 2 | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Abdomen - Principal Inv. | Grade of uptake = 0 | 4 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Abdomen - Principal Inv. | Grade of uptake = 1 | 1 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Abdomen - Principal Inv. | Grade of uptake = 2 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Abdomen - Principal Inv. | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Abdomen - Reviewer 1 | Grade of uptake = 0 | 5 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Abdomen - Reviewer 1 | Grade of uptake = 1 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Abdomen - Reviewer 1 | Grade of uptake = 2 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Abdomen - Reviewer 1 | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Abdomen - Reviewer 2 | Grade of uptake = 0 | 5 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Abdomen - Reviewer 2 | Grade of uptake = 1 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Abdomen - Reviewer 2 | Grade of uptake = 2 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Abdomen - Reviewer 2 | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Abdomen - Principal Inv. | Grade of uptake = 0 | 4 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Abdomen - Principal Inv. | Grade of uptake = 1 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Abdomen - Principal Inv. | Grade of uptake = 2 | 1 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Abdomen - Principal Inv. | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Abdomen - Reviewer 1 | Grade of uptake = 0 | 5 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Abdomen - Reviewer 1 | Grade of uptake = 1 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Abdomen - Reviewer 2 | Grade of uptake = 1 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Abdomen - Reviewer 2 | Grade of uptake = 2 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Abdomen - Reviewer 2 | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Lumbosacral - Principal Inv. | Grade of uptake = 0 | 2 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Lumbosacral - Principal Inv. | Grade of uptake = 1 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Lumbosacral - Principal Inv. | Grade of uptake = 2 | 3 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Lumbosacral - Principal Inv. | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Lumbosacral - Reviewer 1 | Grade of uptake = 0 | 3 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Lumbosacral - Reviewer 1 | Grade of uptake = 1 | 2 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Lumbosacral - Reviewer 1 | Grade of uptake = 2 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Lumbosacral - Reviewer 1 | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Lumbosacral - Reviewer 2 | Grade of uptake = 0 | 5 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Lumbosacral - Reviewer 2 | Grade of uptake = 1 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Lumbosacral - Reviewer 2 | Grade of uptake = 2 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Lumbosacral - Reviewer 2 | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Lumbosacral - Principal Inv. | Grade of uptake = 0 | 2 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Lumbosacral - Principal Inv. | Grade of uptake = 1 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Lumbosacral - Principal Inv. | Grade of uptake = 2 | 2 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Lumbosacral - Principal Inv. | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Lumbosacral - Reviewer 1 | Grade of uptake = 0 | 3 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Lumbosacral - Reviewer 1 | Grade of uptake = 1 | 2 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Lumbosacral - Reviewer 1 | Grade of uptake = 2 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Lumbosacral - Reviewer 1 | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Lumbosacral - Reviewer 2 | Grade of uptake = 0 | 5 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Lumbosacral - Reviewer 2 | Grade of uptake = 1 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Lumbosacral - Reviewer 2 | Grade of uptake = 2 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Lumbosacral - Reviewer 2 | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Sacroiliac Joint - Principal Inv. | Grade of uptake = 0 | 2 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Sacroiliac Joint - Principal Inv. | Grade of uptake = 1 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Sacroiliac Joint - Principal Inv. | Grade of uptake = 2 | 3 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Sacroiliac Joint - Principal Inv. | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Sacroiliac Joint - Reviewer 1 | Grade of uptake = 0 | 5 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Sacroiliac Joint - Reviewer 1 | Grade of uptake = 1 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Sacroiliac Joint - Reviewer 1 | Grade of uptake = 2 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Sacroiliac Joint - Reviewer 1 | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Sacroiliac Joint - Reviewer 2 | Grade of uptake = 0 | 4 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Sacroiliac Joint - Reviewer 2 | Grade of uptake = 1 | 1 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Sacroiliac Joint - Reviewer 2 | Grade of uptake = 2 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 60 minutes: Sacroiliac Joint - Reviewer 2 | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Sacroiliac Joint - Principal Inv. | Grade of uptake = 0 | 1 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Sacroiliac Joint - Principal Inv. | Grade of uptake = 1 | 1 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Sacroiliac Joint - Principal Inv. | Grade of uptake = 2 | 2 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Sacroiliac Joint - Principal Inv. | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Sacroiliac Joint - Reviewer 1 | Grade of uptake = 0 | 5 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Sacroiliac Joint - Reviewer 1 | Grade of uptake = 1 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Sacroiliac Joint - Reviewer 1 | Grade of uptake = 2 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Sacroiliac Joint - Reviewer 1 | Grade of uptake = 3 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Sacroiliac Joint - Reviewer 2 | Grade of uptake = 0 | 4 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Sacroiliac Joint - Reviewer 2 | Grade of uptake = 1 | 1 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Sacroiliac Joint - Reviewer 2 | Grade of uptake = 2 | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake | 120 minutes: Sacroiliac Joint - Reviewer 2 | Grade of uptake = 3 | 0 Participants |
Primary
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.
Time frame: 60 minutes and 120 minutes post investigational product adminstration
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake Adjudication | Abdomen - 60 minutes | Positive | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake Adjudication | Abdomen - 60 minutes | Negative | 5 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake Adjudication | Abdomen - 120 minutes | Positive | 0 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake Adjudication | Whole Body Planar - 60 minutes | Positive | 1 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake Adjudication | Whole Body Planar - 60 minutes | Negative | 4 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake Adjudication | Whole Body Planar - 120 minutes | Positive | 2 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake Adjudication | Whole Body Planar - 120 minutes | Negative | 3 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake Adjudication | Abdomen - 120 minutes | Negative | 5 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake Adjudication | Lumbosacral - 60 minutes | Positive | 2 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake Adjudication | Lumbosacral - 60 minutes | Negative | 3 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake Adjudication | Lumbosacral - 120 minutes | Positive | 2 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake Adjudication | Lumbosacral - 120 minutes | Negative | 3 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake Adjudication | Sacroiliac - 60 minutes | Positive | 1 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake Adjudication | Sacroiliac - 60 minutes | Negative | 4 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake Adjudication | Sacroiliac - 120 minutes | Positive | 1 Participants |
| rhAnnexin V-128 | 99mTc-rhAnnexin V-128 Uptake Adjudication | Sacroiliac - 120 minutes | Negative | 4 Participants |