Clinical trial NCT03232580: 99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: 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.
Lead sponsor: Advanced Accelerator Applications
Sponsor class: INDUSTRY
First posted: 2017-07-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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:

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.

Primary outcomes:
measure: 99mTc-rhAnnexin V-128 Uptake
timeFrame: 60 minutes and 120 minutes post investigational product adminstration
measure: 99mTc-rhAnnexin V-128 Uptake Adjudication
timeFrame: 60 minutes and 120 minutes post investigational product adminstration
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: