Zr-89 Cimzia PET Imaging Rheumatoid Arthritis

NCT03546335 | Suspended Phase 1 DMC FDA Drug

• 1 other identifier: 17-23566
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 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.

  2 years

Study Arms (4)

1 mCi injection of 89Zr-DFO-CZP

EXPERIMENTAL

The first 2 patients will receive 1 mCi of 89Zr-DFO-CZP.

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.

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.

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.

Drug: 89Zr-DFO-CZP

Interventions

89Zr-DFO-CZP DRUG

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).

Also known as: 89Zr-Cimzia

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Robert Flavell, MD, PhD: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Robert Flavell, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor in Residence

Model Details: 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.

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: June 6, 2018
• Study Start: October 1, 2018
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)