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It has been reported that around 40% of GCA patients are able to decrease the prednisone dose until 0.1 mg/Kg/d or less after 6 months of treatment. In this study, we hypothesized that adding 3 months of tocilizumab to prednisone could increase the percentage from 40 to 70%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone+Tocilizumab | Experimental | Prednisone (0.7 mg/Kg/d and then progressively tapered to reach 0.1 mg/Kg/d at W24) + tocilizumab 8mg/Kg/4 weeks for a total of 4 infusions (S0, S4, S8, S12). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| corticoids+ tocilizumab 8mg/Kg/4 weeks | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients in remission with a dose of prednisone ≤ 0.1 mg/kg/day | Remission: absence of symptoms attributable to Giant Cell Arteritis and normalization of inflammatory markers (CRP<10 mg/L and ESR<30 mm/h). Relapse: recurrence of symptoms attributable to active GCA and/or increased levels of inflammatory markers (CRP≥10 mg/L and/or ESR≥30 mm/h). Elevation of inflammatory markers in the absence of GCA symptoms was considered relapse if it persisted at two time points at 1 week apart without any other obvious etiology than GCA. | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and type of adverse effects encountered | Until Week 52 | |
| Percentage of relapses | Week 26 and Week 52 | |
| Time to the first relapse |
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Inclusion Criteria:
Age > 50 years
GCA fulfilling ≥3/5 ACR criteria
Newly diagnosed GCA or relapsing GCA if treatments (Glucocorticoids±immunosuppressants) have been stopped for at least 6 months
Glucocorticoids started for less than 21 days
Proof of large vessel vasculitis:
For men and women of a child-bearing age, an effective method of contraception must be used by the patient or his or her partner throughout the treatment with tocilizumab (or placebo) and for 3 months after the end of the treatment. Breast-feeding is not authorised until 3 months after the end of treatment with tocilizumab. Women not considered at risk of pregnancy are those defined by menopause of at least one year or surgically steriles (ligature of the fallopian tubes, bilateral ovariectomy or hysterectomy)
Persons who have provided written informed consent
Persons covered by the National Health Insurance Agency
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Caen - Hôpital Côte de Nacre | Caen | 14033 | France | |||
| CHU de Dijon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30054122 | Derived | Samson M, Devilliers H, Ly KH, Maurier F, Bienvenu B, Terrier B, Charles P, Guillevin L, Besancenot JF, Liozon E, Fauchais AL, Loffroy R, Binquet C, Audia S, Seror R, Mariette X, Bonnotte B. Tocilizumab as an add-on therapy to glucocorticoids during the first 3 months of treatment of Giant cell arteritis: A prospective study. Eur J Intern Med. 2018 Nov;57:96-104. doi: 10.1016/j.ejim.2018.06.008. Epub 2018 Jul 24. |
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| Until Week 52 |
| Factors associated with the occurrence of relapse | Until Week 52 |
| The cumulative dose of prednisone. | Weeks 26 and 52 |
| Dijon |
| 21079 |
| France |
| Chu Dupuytren | Limoges | 87042 | France |
| Hôpital Edouard HERRIOT | Lyon | 69437 | France |
| Hôpitaux privés de Metz - Site Sainte Blandine | Metz | 57045 | France |
| Institut Mutualiste Montsouris | Paris | 75014 | France |
| Hôpital La Pitié-Salpêtrière | Paris | 75651 | France |
| Hôpital COCHIN | Paris | 75679 | France |
| ID | Term |
|---|---|
| D013700 | Giant Cell Arteritis |
| ID | Term |
|---|---|
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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