Relapse Prediction Following Discontinuation of Tocilizumab In Giant Cell Arteritis

Overview

About this study

The purpose of this study is to identify whether change in the level of inflammation of the arteries at time of drug (tocilizumab) discontinuation compared to six months after drug discontinuation can predict who will or will not relapse. In addition, this study will leverage the use of wearable technology (Oura ring) and machine learning to detect physiologic changes that can forecast flare in order to provide novel methods of patient monitoring and disease detection. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • ≥ 50 years of age.
  • Diagnosis of GCA by confirmation of temporal artery biopsy and/or advanced arterial imaging (CT angiogram, MR angiogram, PET-CT) consistent with large vessel vasculitis.
  • Treated with tocilizumab (subcutaneous OR intravenous) for ≥ 12 months but < 48 months prior to study entry.
  • In clinical remission (that is no symptoms present to suggest active GCA) at study entry.
  • Off prednisone or its equivalent for minimum 2 months prior to study entry.
  • Access to a computer or smartphone/device.

Exclusion Criteria:

  • Uncontrolled diabetes with inability to control glucose level below 200 mg/dl (requirement for obtaining PET-CT).
  • Features of active GCA.
  • Treatment of tocilizumab for other etiologic reason (besides GCA) for which continuation of tocilizumab is deemed necessary (e.g., concomitant rheumatoid arthritis).
  • Ring size smaller than 6 or larger than 13 on digits 2 or 3 (index or middle, respectively).
  • Current (other than non-melanoma skin cancer) malignancy or active infection.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/30/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Koster, M.D.

Open for enrollment

Contact information:

Emily Oldham

(507) 538-7772

Oldham.Emily@mayo.edu

More information

Publications

Publications are currently not available