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99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis

NCT ID: NCT03232580

Last Updated: 2019-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-18

Study Completion Date

2018-11-12

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.

Conditions

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Spondyloarthritis

Keywords

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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.

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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rhAnnexin V-128

All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.

Group Type EXPERIMENTAL

rhAnnexin V-128

Intervention Type DRUG

All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.

Interventions

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rhAnnexin V-128

All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.

Intervention Type DRUG

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:

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanced Accelerator Applications

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CAAA113A22201

Identifier Type: OTHER

Identifier Source: secondary_id

AAA-Annexin-03

Identifier Type: -

Identifier Source: org_study_id