99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of 99mTc-rhAnnexin V-128 Radionuclide Imaging in Patients With Clinical Suspicion or Confirmed Diagnosis of Spondyloarthritis (SpA)

Conditions
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Spondyloarthritis

Intervention / Treatment
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* Drug: rhAnnexin V-128


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rhAnnexin V-128<br>All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0. | Drug: rhAnnexin V-128<br>* All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 60 minutes and 120 minutes post investigational product adminstration | 
| 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. | 60 minutes and 120 minutes post investigational product adminstration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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.