99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis
Condition: Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis
Intervention: rhAnnexin V-128
Intervention description: All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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.

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.
    

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.