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Relapse Prediction Following Discontinuation of Tocilizumab In Giant Cell Arteritis

Overview

Acerca de este estudio

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. 

Elegibilidad para participar

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Ubicaciones participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Ubicación de Mayo Clinic Estado Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Matthew Koster, M.D.

Inscripción abierta

Contact information:

Ayomide Oloyede

(507) 293-2008

oloyede.ayomide@mayo.edu

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20556834

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