Giant Cell ArteritisPhase 3MAGICANCT06037460
TocilizuMab discontinuAtion in GIant Cell Arteritis
A Phase 3 study testing Tocilizumab treatment, questionnaires and Blood samples in people with Giant Cell Arteritis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- Giant Cell Arteritis
- What is being tested?
- Tocilizumab treatment, questionnaires and Blood samples
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2024to Nov 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written consent
- Diagnosis of GCA, defined by the following criteria:
- Age ≥50 years at diagnosis
- AND History of ESR ≥50 mm/h OR CRP ≥20 mg/L (optional criterion if temporal artery biopsy (TAB) is positive).
- AND at least one of the following clinical criteria:
- At least one unequivocal sign of GCA (recent headache, scalp hyperesthesia, jaw claudication, temporal artery abnormality, visual disturbances of ischemic origin)
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- Clinical sign(s) of polymyalgia rheumatica (PR)
- AND at least one of the following criteria during GCA follow-up:
- TAB consistent with the diagnosis of GCA (non-necrotizing vasculitis with a mononuclear cell-rich inflammatory infiltrate or presence of granulomas, with or without multinuclear giant cells)
- Evidence of temporal artery vasculitis by echo-Doppler of the temporal arteries (unilateral or bilateral halo sign)
- Evidence of vasculitis of at least one large vessel by imaging:
- angio-CT or angio-MRI: arterial wall thickening (≥2mm for aorta; ≥1mm for supra-aortic trunks and upper extremity arteries, ≥0.6mm for the cephalic artery, …) and/or T1-weighted contrast.
- PET: grade 2 or 3* hypermetabolism of the wall of at least one large vessel (aorta, supra-aortic trunks, cephalic vessels, upper extremity arteries) (*i.e., arterial SUVmax ≥ liver SUVmax)
- GCA in remission for at least 12 weeks before randomisation (remission = absence of symptoms due to GCA AND CRP ≤10 mg/L)
- TCZ treatment (IV or SC) or biosimilar initiated 12 to 36 months prior to randomization
- TCZ treatment (IV or SC) or biosimilar not interrupted more than 12 weeks in the 12 months prior to randomization
- Treatment with subcutaneous TCZ (162 mg/week) or biosimilar for at least 12 consecutive weeks prior to randomization
- Treatment with corticoids stopped at least 12 weeks before randomization (hydrocortisone treatment ≤20 mg/day is possible if given at a stable dose for the duration of the study)
- Biological workup dating from less than 6 weeks on the day of randomization, showing good tolerance of tocilizumab:
- AST and ALT < 1.5 x upper limit of normal (ULN)
- Hemoglobin >8 g/dL
- Platelets >100 G/L
- Neutrophils >1 G/L
- Lymphocytes >0.5 G/L
Who cannot join
- Person who is not affiliated with the national health insurance system
- Person subject to a measure of legal protection (guardianship, tutorship)
- Person subject to a court order
- Patient unable to give consent
- Person who does not speak French
- Pre-menopausal women (menopause = amenorrhea of more than 12 consecutive months)
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- Uncontrolled psychotic state
- History of drug or alcohol intoxication requiring hospitalization within 12 months prior to randomization
- Recent or scheduled surgery within 6 months of randomization
- History of organ or hematopoietic marrow transplantation (except corneal transplantation performed at least 12 weeks prior to randomization)
- Primary or secondary immune deficiency
- Concomitant treatment with any of the following:
- Methotrexate, leflunomide, cyclosporin A, azathioprine, mycophenolate mofetil, Janus kinase inhibitors, abatacept, secukinumab, anti-TNF-α, anakinra, ustekinumab, or any other immunosuppressive drug within 12 weeks prior to randomization
- Rituximab or other anti-CD20 agent within 1 year prior to randomization
- Cyclophosphamide in the year prior to randomization
- History of long-term corticosteroid therapy for conditions other than GCA or PPR. (NB: dermocorticoids, inhaled corticosteroids, and corticosteroid joint infiltrations are allowed during the study)
- Patient who has previously received ≥3 courses of oral corticosteroids for a disease other than GCA or RRP within 6 months prior to randomization
- Ongoing anti-tuberculosis treatment at the time of randomization
- Infections:
- Current viral hepatitis B or C
- Ongoing HIV infection
- Severe infection requiring hospitalization within 30 days prior to randomization
- Any unstable or poorly controlled condition or disease, acute or chronic, not related to GCA, and considered a contraindication to tocilizumab therapy in the opinion of the investigator
- Neoplasia < 5 years, (except cervical cancer in situ and skin carcinoma, except melanoma, with R0 resection)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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 the last injection of TCZ, and the risk of relapse is higher if the large arteries (aorta and its branches) are involved.
Thus, although the available data are limited, it appears that tapering rather than immediately stopping TCZ limits the risk of relapse after full withdrawal.
- Conditions
- Giant Cell Arteritis
- Being tested
- Tocilizumab treatment, questionnaires, Blood samples, 18FDG PET scan
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocilizumab treatmentDrug
- 1 injection/2 weeks from W0 to W12: W0, W2, W4, W6, W8, W10, W12
- Then 1 injection/4 weeks until W24: W16, W20, W24
questionnairesOther
HAQ, SF-36, FACIT-Fatigue score
Blood samplesBiological
Additionnal blood samples for immunomonitoring
18FDG PET scanProcedure or surgery
PETVAS calculation (to be performed between W0 and W8) (optional).
| Study group | Role | What they receive |
|---|---|---|
| Gradual discontinuation of TCZ | Experimental | Not described Receives: Drug: Tocilizumab treatment; Other: questionnaires; Biological: Blood samples; Procedure: 18FDG PET scan |
| Immediate discontinuation of TCZ | Active comparator | Not described Receives: Other: questionnaires; Biological: Blood samples; Procedure: 18FDG PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relapse-free survival in both groups (immediate vs. gradual discontinuation)
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.
Measured: at 26 weeks of follow-up
Secondary outcomes (9)
Relapse-free survival in both groups (immediate vs. gradual discontinuation)
Measured: at 26, 52 and 78 weeks of follow-up
Cumulative prednisone dose
Measured: at 26, 52 and 78 weeks of follow-up
Quality of life scores (HAQ)
Measured: at 0, 12, 26, 52 and 78 weeks of follow-up
FACIT-Fatigue score
Measured: at 0, 12, 26, 52 and 78 weeks of follow-up
Percentage of patients in remission without prednisone
Measured: at 26, 52 and 78 weeks of follow-up
Percentage of patients in remission with prednisone dose ≤5 mg/day
Measured: at 26, 52 and 78 weeks of follow-up
Frequency and type of adverse events in both groups
Measured: during the first 78 weeks after inclusion
Frequency of corticosteroid-related side effects (GTI score) in both groups
Measured: at baseline and at 52 weeks of follow-up
Quality of life scores (SF-36)
Measured: at 0, 12, 26, 52 and 78 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start13 May 2024
- Primary completionDec 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037460
- Sponsor's protocol ID
- SAMSON PHRCN 2021
- Acronym
- MAGICA
- Status last verified
- Apr 2026
- First submitted
- 7 Sep 2023
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Samson M, Fournel I, Bourredjem A, Cortier M, Galizzi E, Cransac A, Cladiere C, Fleck C, Brayer M, Carpentier M, Alberini JL, Devilliers H, Bonnotte B. Immediate versus gradual TocilizuMab discontinuAtion in GIant Cell Arteritis: protocol of the multicentre randomised open-label MAGICA trial. BMJ Open. 2025 Oct 9;15(10):e108115. doi: 10.1136/bmjopen-2025-108115.
PubMed 41067765
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TocilizuMab discontinuAtion in GIant Cell Arteritis
- ClinicalTrials.gov ID
- NCT06037460
- Acronym / sponsor ID
- MAGICA / SAMSON PHRCN 2021
- Conditions
- Giant Cell Arteritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 the last injection of TCZ, and the risk of relapse is higher if the large arteries (aorta and its branches) are involved.
Thus, although the available data are limited, it appears that tapering rather than immediately stopping TCZ limits the risk of relapse after full withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gradual discontinuation of TCZ | Experimental | Drug: Tocilizumab treatment, Other: questionnaires, Biological: Blood samples, Procedure: 18FDG PET scan |
| Immediate discontinuation of TCZ | Active comparator | Other: questionnaires, Biological: Blood samples, Procedure: 18FDG PET scan |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Written consent
- Diagnosis of GCA, defined by the following criteria:
- GCA in remission for at least 12 weeks before randomisation (remission = absence of symptoms due to GCA AND CRP ≤10 mg/L)
- TCZ treatment (IV or SC) or biosimilar initiated 12 to 36 months prior to randomization
- TCZ treatment (IV or SC) or biosimilar not interrupted more than 12 weeks in the 12 months prior to randomization
Key exclusion criteria (24 listed)
- Person who is not affiliated with the national health insurance system
- Person subject to a measure of legal protection (guardianship, tutorship)
- Person subject to a court order
- Patient unable to give consent
- Person who does not speak French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tocilizumab treatment* 1 injection/2 weeks from W0 to W12: W0, W2, W4, W6, W8, W10, W12 * Then 1 injection/4 weeks until W24: W16, W20, W24 | Drug | Gradual discontinuation of TCZ |
| questionnairesHAQ, SF-36, FACIT-Fatigue score | Other | Gradual discontinuation of TCZ, Immediate discontinuation of TCZ |
| Blood samplesAdditionnal blood samples for immunomonitoring | Biological | Gradual discontinuation of TCZ, Immediate discontinuation of TCZ |
| 18FDG PET scanPETVAS calculation (to be performed between W0 and W8) (optional). | Procedure or surgery | Gradual discontinuation of TCZ, Immediate discontinuation of TCZ |
Primary outcome
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.
9 secondary outcomes
Relapse-free survival in both groups (immediate vs. gradual discontinuation)
Time frame: at 26, 52 and 78 weeks of follow-up
Cumulative prednisone dose
Time frame: at 26, 52 and 78 weeks of follow-up
Quality of life scores (HAQ)
Time frame: at 0, 12, 26, 52 and 78 weeks of follow-up
FACIT-Fatigue score
Time frame: at 0, 12, 26, 52 and 78 weeks of follow-up
Percentage of patients in remission without prednisone
Time frame: at 26, 52 and 78 weeks of follow-up
Percentage of patients in remission with prednisone dose ≤5 mg/day
Time frame: at 26, 52 and 78 weeks of follow-up
Frequency and type of adverse events in both groups
Time frame: during the first 78 weeks after inclusion
Frequency of corticosteroid-related side effects (GTI score) in both groups
Time frame: at baseline and at 52 weeks of follow-up
Quality of life scores (SF-36)
Time frame: at 0, 12, 26, 52 and 78 weeks of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 41067765Samson M, Fournel I, Bourredjem A, Cortier M, Galizzi E, Cransac A, Cladiere C, Fleck C, Brayer M, Carpentier M, Alberini JL, Devilliers H, Bonnotte B. Immediate versus gradual TocilizuMab discontinuAtion in GIant Cell Arteritis: protocol of the multicentre randomised open-label MAGICA trial. BMJ Open. 2025 Oct 9;15(10):e108115. doi: 10.1136/bmjopen-2025-108115.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tocilizumab treatment, questionnaires and Blood samples in people with Giant Cell Arteritis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relapse-free survival in both groups (immediate vs. gradual discontinuation) (time frame: at 26 weeks of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06037460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.