Loading search results

Outcome Measures

Primary Outcomes (1)

Percentage of patients alive without relapse after initial remission or deviation from the scheduled regimen of prednisone at week 78 (W78).

Secondary Outcomes (14)

Percentage of patients alive without relapse after initial remission or deviation from the scheduled regimen of prednisone at W52 and 104
Number of patients needed to treat to avoid 1 relapse at W52, 78 and 104, and will be calculated as 1/ absolute risk reduction, that is the difference between the relapse rate in TCZ group and the relapse rate in the MTX group.
Percentage of patients in remission without prednisone at W52, 78, 104 and 156
Percentage of patients in remission with prednisone ≤5 mg/day at W52, 78, 104 and 156
Cumulative dose of prednisone at W52, 78, 104 and 156
+9 more secondary outcomes

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product

RoActemra 162 mg solution for injection in pre-filled syringe.

The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.

SOLUTION FOR INJECTION

View registry record

Formulated product

FOLIC ACID

The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.

TABLET

View registry record

Formulated product

CORTANCYL 5 mg, comprimé sécable

The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.

TABLET

View registry record

Formulated product

METHOTREXATE

The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.

SOLUTION FOR INJECTION

View registry record

Formulated product

CORTANCYL 1 mg, comprimé

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

RoActemra 162 mg solution for injection in pre-filled syringe.

Named ingredient: tocilizumab

View registry record

FOLIC ACID

Named ingredient: Folic acid

View registry record

CORTANCYL 5 mg, comprimé sécable

Named ingredient: Prednisone

View registry record

METHOTREXATE

Named ingredient: Methotrexate

View registry record

CORTANCYL 1 mg, comprimé

Named ingredient: Prednisone

View registry record

CORTANCYL 20 mg, comprimé sécable

Named ingredient: Prednisone

View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written consent
Affiliation to a social security system
Diagnosis of GCA, as defined by the revised GCA diagnosis criteria : Age ≥50 years at disease onset / AND History of erythrocyte sedimentation rate (ESR) ≥50 mm/h OR CRP≥20 mg/L (not mandatory if TAB is positive: see below) / AND At least one of the following: unequivocal cranial symptoms of GCA (new onset headache, scalp tenderness, jaw claudication, temporal artery abnormality, ischemia-related vision loss) OR unequivocal symptoms of polymyalgia rheumatica (PMR) / AND At least one of the following: Temporal artery biopsy (TAB) compatible with the diagnosis of GCA (non-necrotizing vasculitis with a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells) OR Evidence of large vessel vasculitis (aorta and/or epiaortic arteries) : (angio-CT or angio-MRI: thickened arterial wall (≥2mm for the aorta and ≥1mm for epiaortic arteries) and/or contrast-enhanced arteries in T1-weighted sequences) - (PET scan: grade 3 tracer uptake of the arterial wall (grade 3 = arterial SUVmax superior to the SUVmax of the liver))

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier

2024-512269-14-00

Data provider

European Medicines Agency (EMA)

Normalization version

ctis-v1

Source retrieved: 2026-10-30 04:50:45 UTC

MEthotrexate versus TOcilizumab for treatment of GIant cell Arteritis: a multicenter, randomized, controlled trial

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (41)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (41)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations