NCT06037460: MAGICA

TocilizuMab discontinuAtion in GIant Cell Arteritis

Active, enrolled Phase 3 Last updated 28 April 2026

What this trial tests

Phase 3 trial testing Tocilizumab treatment in Giant Cell Arteritis in 120 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 May 2024

Primary endpoint
1 December 2027

1 November 2028

Quick facts

Lead sponsor	Centre Hospitalier Universitaire Dijon
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	13 May 2024
Primary completion	1 December 2027
Estimated completion	1 November 2028
Sites	1 location across France

Drugs / interventions tested

• Tocilizumab treatment — full drug profile →
• questionnaires
• Blood samples — full drug profile →
• 18FDG PET scan

Conditions studied

• Giant Cell Arteritis — all drugs for Giant Cell Arteritis →

Sponsor

Centre Hospitalier Universitaire Dijon

Who can join

51 and older, any sex, with Giant Cell Arteritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The relapse-free survival in both groups (immediate vs. gradual discontinuation)
  Time frame: at 26 weeks of follow-up
  The relapse-free survival in both groups (immediate vs. gradual discontinuation) defined as the time from S0 (start of immediate/progressive discontinuation strategy) to relapse or death (any cause), whichever occurs first.

Sponsor's own description

Giant cell arteritis (GCA) is a large-vessel vasculitis that typically occurs in people over the age of 50.

Corticosteroids (GC) are the cornerstone of treatment for GCA. French guidelines recommend starting at 0.7 or 1 mg/kg/day at diagnosis, depending on the occurence of ischemic complication(s). Then, it is recommended to gradually decrease their dose to achieve withdrawal in 12 to 24 months.

Despite this treatment, 47% of patients relapse. Relapses are favored by rapid reduction of corticosteroid doses and large vessel involvement at diagnosis. Fortunately, relapses are severe in only 3.3% of cases and ischemic complications are very rare. However, this contributes to prolonging the duration of corticosteroid treatment and thus the risk of cortico-induced adverse events, which have not been significantly reduced in the last 20 years. The main risk factors for the development of steroid-related complications are advanced age and cumulative steroid dose.

For this reason, the development of cortisone-sparing strategies is necessary to improve the management of patients with GCA. Thanks to major advances in the understanding of the pathophysiological mechanisms of GCA, new therapeutic targets have been discovered. For example, the efficacy of tocilizumab (TCZ), an anti-IL-6 receptor monoclonal antibody, has been demonstrated in two phase 2 trials and one phase 3 trial, leading to its approval for the management of patients requiring rapid reduction in corticosteroid doses and/or those relapsing repeatedly on prednisone \>7.5 mg/day. In recently published US guidelines, TCZ can even be used at diagnosis to reduce the need for corticosteroid therapy.5 Indeed, TCZ appears to be remarkably effective in controlling GCA activity and saves approximately 2000 mg of prednisone in cumulative dose.

At present, the place of TCZ compared to methotrexate in the therapeutic strategy is still being evaluated, notably through the METOGiA study (PHRC-N 2017), which is being conducted by our team. Inclusions for METOGiA ended in March 2023 with results expected in 2025. Outside of this study, approximately 1500 patients are currently receiving TCZ treatment for GCA (data from ROCHE-CHUGAI).

There is no doubt that TCZ treatment is effective and rather well tolerated in the elderly population, but it generates problems that are not solved to date:

* the cost (\~900€/month)
* the difficulty monitoring these patients because the biological markers usually used to monitor GCA (CRP, ESR, fibrinogen) can no longer be measured since TCZ blocks their production by the hepatocytes. Monitoring of disease activity therefore requires very careful clinical examination and the use of expensive imaging tests such as PET scans because GCA can be active despite normal ESR, CRP and fibrinogen levels. Some studies suggest that monitoring serum IL-6 may help identify patients with active disease, but this test is not readily available and the threshold above which relapse should be suspected is unclear because TCZ induces an increase in serum IL-6 levels by blocking IL-6 receptors, even in patients in remission.
* For the same reasons, infections are difficult to detect in patients treated with TCZ.

This raises the question of how to discontinue this treatment, especially since other treatments that do not interfere with CRP, ESR, or fibrinogen measurements are being evaluated.

This shows that this treatment tends to be prolonged well beyond one year when the disease is often in remission without corticosteroids. This is probably related to two factors: 1/ the fear of relapse after treatment withdrawal; 2/ the absence of a scheme for withdrawing TCZ.

The risk of relapse after stopping TCZ has been reported in several studies, in particular the long-term follow-up of phase 2 and 3 trials that demonstrated the efficacy of TCZ for the treatment of GCA. Overall, regardless of the duration of TCZ treatment, the risk of relapse is approximately 40% 6 months after

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current Perspectives in Giant Cell Arteritis: Can We Better Connect Pathogenesis and Treatment?
   Opriș-Belinski D, Cobilinschi CO, Săulescu I. · · 2024 · cited 2× · PMID 38541126 · DOI 10.3390/medicina60030400
2. Immediate versus gradual Tocilizu<b>M</b>ab discontinuAtion in G<b>I</b>ant Cell Arteritis: protocol of the multicentre randomised open-label MAGICA trial.
   Samson M, Fournel I, Bourredjem A, Cortier M, et al · · 2025 · PMID 41067765 · DOI 10.1136/bmjopen-2025-108115