Authorised Phase III and phase IV (Integrated) anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides

EFFECT OF ONCE VS TWICE DAILY ADMINISTRATION OF CORTICOSTEROIDS ON BLOOD GLUCOSE IN PATIENTS WITH ANCA-VASCULITIS MEASURED BY CONTINUOUS BLOOD GLUCOSE MONITORING - A PILOT STUDY

EU CTIS ID: 2024-516141-39-00

What this study is testing

Evaluation of whether splitting the cortisone dose to a twice daily dose leads to increased time in the glucose target range.

  • Phase III and phase IV (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Written agreement to participate in the study after detailed explanation of the study
  • Male or female patients
  • New diagnosis of ANCA-associated vasculitis or a relapse of a known ANCA vasculitis
  • Age: ≥18-80 years at the time of biopsy
  • Aprednislon dose of 1mg/kg body weight at the time of inclusion
  • Wants to wear a CGM system for the duration of the study and to receive insulin therapy as needed

You likely can't join if

  • Known diabetes mellitus
  • Women capable of giving birth who are pregnant, breastfeeding, wish to become pregnant or do not use adequate contraception.
  • Skin changes or concomitant circumstances that prevent the placement of a glucose sensor in the examiner's assessment (e.g. scar tissue)
  • Current participation in another clinical trial that would affect study results
  • Relevant acute or chronic disease that, in the investigator's estimation, could affect the patient's safety or affect the study results.
  • Patient's inability to follow study procedures as required
See the full eligibility criteria
Who can join
  • Written agreement to participate in the study after detailed explanation of the study
  • Male or female patients
  • New diagnosis of ANCA-associated vasculitis or a relapse of a known ANCA vasculitis
  • Age: ≥18-80 years at the time of biopsy
  • Aprednislon dose of 1mg/kg body weight at the time of inclusion
  • Wants to wear a CGM system for the duration of the study and to receive insulin therapy as needed
What rules you out
  • Known diabetes mellitus
  • Women capable of giving birth who are pregnant, breastfeeding, wish to become pregnant or do not use adequate contraception.
  • Skin changes or concomitant circumstances that prevent the placement of a glucose sensor in the examiner's assessment (e.g. scar tissue)
  • Current participation in another clinical trial that would affect study results
  • Relevant acute or chronic disease that, in the investigator's estimation, could affect the patient's safety or affect the study results.
  • Patient's inability to follow study procedures as required
  • Inability of the patient to understand the consent form

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.