Treatment for Giant Cell Arteritis With Tocilizumab and 8 as Compared to 26 Weeks of Prednisone

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

The GISCO study plans to determine whether 8-week therapy is just as effective as 26-week cortisone therapy for treating giant cell arteritis

* with tocilizumab, * while using less cortisone.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with giant cell arteritis

Start of tocilizumab treatment at baseline as part of routine clinical practice

Receive ≥ 20 mg/day prednisone (or equivalent) at baseline

Written informed consent

Disqualifiers

Treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of tocilizumab.

Trial design

Design model

Single group

Treatments tested in this trial

  • Prednisone

    Drug

    Participant randomization to receive shortened (8 weeks) glucocorticoid taper upon initiation of a glucocorticoid-sparing agent.

  • Prednisone

    Drug

    Participant randomization to receive standard (26 weeks) glucocorticoid taper upon initiation of a glucocorticoid-sparing agent.

Treatment groups

178 Participants
are divided into 2 treatment groups
Group A: 26 weeks glucocorticoidActive comparator 1 intervention
Group B: 8 weeks glucocorticoidExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Absence of a major relapse from randomization to 52 weeks

Composite endpoint. Pairwise comparisons of each patient from the control arm with each patient of the experimental arm.

Time frame
52 weeks
2

Cumulative glucocorticoid exposure from randomization to 52 weeks

Composite endpoint. Pairwise comparisons of each patient from the control arm with each patient of the experimental arm.

Time frame
52 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: