SpondyloarthritisPhase 2Annexin 03NCT03232580
99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis
A Phase 2 study testing rhAnnexin V-128 in people with Spondyloarthritis, run by Advanced Accelerator Applications at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis
- What is being tested?
- rhAnnexin V-128
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2017to 12 Nov 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Phase II Study of 99mTc-rhAnnexin V-128 Radionuclide Imaging in Patients With Clinical Suspicion or Confirmed Diagnosis of Spondyloarthritis (SpA)
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.
Read the 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.
- Conditions
- Spondyloarthritis
- Being tested
- rhAnnexin V-128
- 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.
- Medical subject headings
- Spondylarthritis, Spondylitis, Ankylosing, Inflammatory Bowel Diseases, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhAnnexin V-128Drug
All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.
| Study group | Role | What they receive |
|---|---|---|
| rhAnnexin V-128 | Experimental | All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0. Receives: Drug: rhAnnexin V-128 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 60 minutes and 120 minutes post investigational product adminstration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start18 Sep 2017
- Primary completion12 Nov 2018
- Study completion12 Nov 2018
Why it stopped: Sponsor Decision based on strategic considerations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Accelerator Applications
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232580
- Sponsor's protocol ID
- AAA-Annexin-03
- Other IDs
- CAAA113A22201
- Acronym
- Annexin 03
- Status last verified
- Dec 2019
- First submitted
- 13 Jul 2017
- Last updated
- 13 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of 99mTc-rhAnnexin V-128 Radionuclide Imaging in Patients With Clinical Suspicion or Confirmed Diagnosis of Spondyloarthritis (SpA)
- ClinicalTrials.gov ID
- NCT03232580
- Acronym / sponsor ID
- Annexin 03 / AAA-Annexin-03
- Conditions
- Spondyloarthritis
- Keywords
- Suspicion or confirmed diagnosis of Spondyloarthritis, Ankylosing Spondylarthritis, Ankylosing Spondylitis, Ankylosing Spondyloarthritis, Rheumatoid Spondylitis, Spondylarthritis Ankylopoietica, Spondylitis Ankylopoietica, Spondyloarthritis Ankylopoietica
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision based on strategic considerations.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Advanced Accelerator ApplicationsIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Posted 13 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rhAnnexin V-128 | Experimental | Drug: rhAnnexin V-128All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
- 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:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhAnnexin V-128All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0. | Drug | rhAnnexin V-128 |
Primary outcome
99mTc-rhAnnexin V-128 Uptake
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rhAnnexin V-128 in people with Spondyloarthritis, run by Advanced Accelerator Applications at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
99mTc-rhAnnexin V-128 Uptake (time frame: 60 minutes and 120 minutes post investigational product adminstration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.