Rheumatoid ArthritisPhase 1NCT03546335
Zr-89 Cimzia PET Imaging Rheumatoid Arthritis
A Phase 1 study testing 89Zr-DFO-CZP in people with Rheumatoid Arthritis, run by Robert Flavell, MD, PhD at 1 site in United States.
Trial summary
This is a single center exploratory imaging study investigating the initial application of zirconium-89 Deferoxamine B Certolizumab pegol (89Zr-DFO-CZP) PET in patients with rheumatoid arthritis. Patients with active symptoms of RA or signs on physical exam will be invited to participate for PET imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- 89Zr-DFO-CZP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 31 Mar 2029
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Age > 18 years old.
- Ability to read and understand written informed consent document.
- Patients with clinical diagnosis of rheumatoid arthritis.
Who cannot join
- For patients planning to be imaged on PET (positron emission tomography) / MRI (magnetic resonance imaging) (PET/MR) scanner, exclusion criteria will include any contra-indication to MRI, including permanent pacemaker, implantable metallic device/ prosthetic, aneurysm clip, non-removable piercing, or severe claustrophobia.
- Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator.
- Patients who have had a study involving radiation within one year of enrolling in this study.
- Patients who are pregnant (female patients of childbearing age will be tested prior to injection of imaging agent - positive test will exclude from participating in the study).
- Patients who are breastfeeding.
- Patients who cannot confirm that they will use reliable contraceptive methods for 90 days.
- Patients treated with TNF-alpha inhibitor therapy.
- Females of child-bearing age (<50 years old), until data from the dose-finding study has been reviewed by the UCSF Radiation Safety Committee and explicit written permission has been provided by the UCSF Radiation Safety Committee to open the window of potential female participants to ages 18 years and older.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Zirconium-89 Certolizumab PET Imaging in Patients With Rheumatoid Arthritis
This is a single center exploratory imaging study investigating the initial application of zirconium-89 Deferoxamine B Certolizumab pegol (89Zr-DFO-CZP) PET in patients with rheumatoid arthritis. Patients with active symptoms of RA or signs on physical exam will be invited to participate for PET imaging.
Read the detailed description
This is a single center exploratory imaging study investigating the initial application of 89Zr-DFO-CZP PET in patients with rheumatoid arthritis. Patients with active symptoms of rheumatoid arthritis (RA) or signs on physical exam will be invited to participate for PET imaging. Study 1 is a dose finding study that will involve a single 89Zr-DFO-CZP PET scan acquired ~24 hours following a single administration of the radiopharmaceutical. The first 2 patients will receive 1 millicurie (mCi) of 89Zr-DFO-CZP. Subsequent groups of two patients will receive 0.5 mCi decrease or increase dose (up to 2 mCi) to determine the acceptable optimal imaging dose. After receiving the dose, participants will undergo 4 serial whole body PET scans between 2 hours and 120 hours after dose administration. Several blood samples will also be collected over this time period, for dosimetry analysis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- 89Zr-DFO-CZP
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-DFO-CZPDrug
Also called 89Zr-Cimzia
89Zr-DFO-Certolizumab pegol (89Zr-DFO-CZP) is a radiopharmaceutical imaging agent that will be produced under Current Good Manufacturing Practice (CGMP) regulations in the Department of Radiology and Biomedical Imaging Radiopharmaceutical Facility at University of California, San Francisco (UCSF).
| Study group | Role | What they receive |
|---|---|---|
| 1 mCi injection of 89Zr-DFO-CZP | Experimental | The first 2 patients will receive 1 mCi of 89Zr-DFO-CZP. Receives: Drug: 89Zr-DFO-CZP |
| 0.5 mCi injection of 89Zr-DFO-CZP | Experimental | Subsequent groups of two patients will receive 0.5 mCi decrease or increase dose (up to 2 mCi) to determine the acceptable optimal imaging dose. Receives: Drug: 89Zr-DFO-CZP |
| 1.5 mCi injection of 89Zr-DFO-CZP | Experimental | Subsequent groups of two patients will receive 0.5 mCi decrease or increase dose (up to 2 mCi) to determine the acceptable optimal imaging dose. Receives: Drug: 89Zr-DFO-CZP |
| 2 mCi injection of 89Zr-DFO-CZP | Experimental | Subsequent groups of two patients will receive 0.5 mCi decrease or increase dose (up to 2 mCi) to determine the acceptable optimal imaging dose. Receives: Drug: 89Zr-DFO-CZP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of 89Zr-DFO-CZP taken up in symptomatic versus asymptomatic joints of patients with rheumatoid arthritis (RA).
Investigators will be evaluating whether 89Zr-DFO-CZP is taken up in symptomatic versus asymptomatic joints of patients with rheumatoid arthritis (RA).
Measured: 2 years
Secondary outcomes (1)
Uptake of 89Zr-DFO-CZP in symptomatic joints of patients with rheumatoid arthritis after administration of a Tumour Necrosis Factor alpha (TNF-alpha) inhibitor therapeutic.
Investigators will be evaluating the uptake of 89Zr-DFO-CZP in symptomatic joints of patients with rheumatoid arthritis after administration of a TNF-alpha inhibitor therapeutic.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 Oct 2018
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Why it stopped: Lapse in study funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The first 2 patients will receive 1 mCi of 89Zr-DFO-CZP. Subsequent groups of two patients will receive 0.5 mCi decrease or increase dose (up to 2 mCi) to determine the acceptable optimal imaging dose.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Flavell, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Flavell, MD, PhD, University of California, San Francisco
- Investigators
- Robert Flavell, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546335
- Sponsor's protocol ID
- 17-23566
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2018
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zirconium-89 Certolizumab PET Imaging in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03546335
- Acronym / sponsor ID
- 17-23566
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lapse in study funding.
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Robert Flavell, MD, PhDUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center exploratory imaging study investigating the initial application of zirconium-89 Deferoxamine B Certolizumab pegol (89Zr-DFO-CZP) PET in patients with rheumatoid arthritis. Patients with active symptoms of RA or signs on physical exam will be invited to participate for PET imaging.
Detailed description
This is a single center exploratory imaging study investigating the initial application of 89Zr-DFO-CZP PET in patients with rheumatoid arthritis. Patients with active symptoms of rheumatoid arthritis (RA) or signs on physical exam will be invited to participate for PET imaging. Study 1 is a dose finding study that will involve a single 89Zr-DFO-CZP PET scan acquired ~24 hours following a single administration of the radiopharmaceutical. The first 2 patients will receive 1 millicurie (mCi) of 89Zr-DFO-CZP. Subsequent groups of two patients will receive 0.5 mCi decrease or increase dose (up to 2 mCi) to determine the acceptable optimal imaging dose. After receiving the dose, participants will undergo 4 serial whole body PET scans between 2 hours and 120 hours after dose administration. Several blood samples will also be collected over this time period, for dosimetry analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The first 2 patients will receive 1 mCi of 89Zr-DFO-CZP. Subsequent groups of two patients will receive 0.5 mCi decrease or increase dose (up to 2 mCi) to determine the acceptable optimal imaging dose.
| Arm | Type | Receives |
|---|---|---|
| 1 mCi injection of 89Zr-DFO-CZP | Experimental | Drug: 89Zr-DFO-CZPThe first 2 patients will receive 1 mCi of 89Zr-DFO-CZP. |
| 0.5 mCi injection of 89Zr-DFO-CZP | Experimental | Drug: 89Zr-DFO-CZPSubsequent groups of two patients will receive 0.5 mCi decrease or increase dose (up to 2 mCi) to determine the acceptable optimal imaging dose. |
| 1.5 mCi injection of 89Zr-DFO-CZP | Experimental | Drug: 89Zr-DFO-CZPSubsequent groups of two patients will receive 0.5 mCi decrease or increase dose (up to 2 mCi) to determine the acceptable optimal imaging dose. |
| 2 mCi injection of 89Zr-DFO-CZP | Experimental | Drug: 89Zr-DFO-CZPSubsequent groups of two patients will receive 0.5 mCi decrease or increase dose (up to 2 mCi) to determine the acceptable optimal imaging dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years old.
- Ability to read and understand written informed consent document.
- Patients with clinical diagnosis of rheumatoid arthritis.
Key exclusion criteria (8 listed)
- For patients planning to be imaged on PET (positron emission tomography) / MRI (magnetic resonance imaging) (PET/MR) scanner, exclusion criteria will include any contra-indication to MRI, including permanent pacemaker, implantable metallic device/ prosthetic, aneurysm clip, non-removable piercing, or severe claustrophobia.
- Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator.
- Patients who have had a study involving radiation within one year of enrolling in this study.
- Patients who are pregnant (female patients of childbearing age will be tested prior to injection of imaging agent - positive test will exclude from participating in the study).
- Patients who are breastfeeding.
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 |
|---|---|---|
| 89Zr-DFO-CZPAlso: 89Zr-Cimzia89Zr-DFO-Certolizumab pegol (89Zr-DFO-CZP) is a radiopharmaceutical imaging agent that will be produced under Current Good Manufacturing Practice (CGMP) regulations in the Department of Radiology and Biomedical Imaging Radiopharmaceutical Facility at University of California, San Francisco (UCSF). | Drug | 0.5 mCi injection of 89Zr-DFO-CZP, 1 mCi injection of 89Zr-DFO-CZP, 1.5 mCi injection of 89Zr-DFO-CZP, 2 mCi injection of 89Zr-DFO-CZP |
Primary outcome
Uptake of 89Zr-DFO-CZP taken up in symptomatic versus asymptomatic joints of patients with rheumatoid arthritis (RA).
Time frame: 2 years
Investigators will be evaluating whether 89Zr-DFO-CZP is taken up in symptomatic versus asymptomatic joints of patients with rheumatoid arthritis (RA).
1 secondary outcome
Uptake of 89Zr-DFO-CZP in symptomatic joints of patients with rheumatoid arthritis after administration of a Tumour Necrosis Factor alpha (TNF-alpha) inhibitor therapeutic.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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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.
Robert Flavell, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 89Zr-DFO-CZP in people with Rheumatoid Arthritis, run by Robert Flavell, MD, PhD 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 3 inclusion and 8 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: paused, as of the sponsor's last update on 4 May 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Uptake of 89Zr-DFO-CZP taken up in symptomatic versus asymptomatic joints of patients with rheumatoid arthritis (RA). (time frame: 2 years). 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 4 May 2026.