Zr-89 Cimzia PET Imaging Rheumatoid Arthritis

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.

Study Overview

• Status: Suspended
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: 89Zr-DFO-CZP

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age > 18 years old.
2. Ability to read and understand written informed consent document.
3. Patients with clinical diagnosis of rheumatoid arthritis.

Exclusion Criteria:

1. 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.
2. Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator.
3. Patients who have had a study involving radiation within one year of enrolling in this study.
4. 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).
5. Patients who are breastfeeding.
6. Patients who cannot confirm that they will use reliable contraceptive methods for 90 days.
7. Patients treated with TNF-alpha inhibitor therapy.
8. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 mCi injection of 89Zr-DFO-CZP; The first 2 patients will receive 1 mCi of 89Zr-DFO-CZP.	Drug: 89Zr-DFO-CZP; 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).; Other Names: 89Zr-Cimzia
Experimental: 0.5 mCi injection 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.	Drug: 89Zr-DFO-CZP; 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).; Other Names: 89Zr-Cimzia
Experimental: 1.5 mCi injection 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.	Drug: 89Zr-DFO-CZP; 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).; Other Names: 89Zr-Cimzia
Experimental: 2 mCi injection 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.	Drug: 89Zr-DFO-CZP; 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).; Other Names: 89Zr-Cimzia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: Robert Flavell, MD, PhD
• Investigators: Principal Investigator: Robert Flavell, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid
• Other Study ID Numbers: 17-23566

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No