SYFbf907ce1ab7246a5a475a2c060b46a4aRegistry ID: 2023-506623-29-01|RecruitingPhase 2
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interventional
N/A
1 country
6
To compare the effectiveness of treatment with etanercept (ETN) versus methotrexate (MTX) in the induction of sustained steroid-free remission in patients with giant cell arteritis (GCA).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 5, 2024
Actual (reported)Percentage of sustained steroid-free GCA remission at week 52 from randomization, defined as lack of symptoms and signs attributable to GCA and not related to prior damage and normalization of inflammatory markers (i.e. ESR < 30 mm/1 hour and CRP < 10 mg/L) with adherence to the protocol-defined prednisone taper regimen.
Mortality rate in the course of GCA at 52 and 104 week from randomization.
Percentage of severe ischemic complications of GCA at 52 and 104 week, defined as: a. stroke, b. myocardial infarction, c. complete or partial vision loss, d. limb ischemia, e. ischemia of organs important for the patient's survival (i.e. lungs, kidneys, alimentary tract).
Percentage of sustained steroid-free GCA remission at week 104 from randomization, defined as lack of symptoms and signs attributable to GCA and not related to prior damage and normalization of inflammatory markers (ESR < 30 mm/1 hour and CRP < 10 mg/L) with adherence to the protocol-defined prednisone taper regimen.
Percentage of GCA remission at 24, 52, 78 and 104 week from randomization, defined as lack of symptoms and signs attributable to GCA and not related to prior damage and normalization of inflammatory markers (i.e. ESR < 30 mm/1 hour and CRP < 10 mg/L).
Percentage of GCA remission (defined as lack of symptoms and signs attributable to GCA and not related to prior damage and normalization of inflammatory markers, i.e. ESR < 30 mm/1 hour and CRP < 10 mg/L) with concomitant achievement of prednisone dose ≤ 5mg/day at 26, 52, 78 and 104 week from randomization.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
METHOTREXATE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
METHOTREXATE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
METHOTREXATE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
PREDNISONE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
METHOTREXATE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
METHOTREXATE
Named ingredient: Methotrexate
View registry recordMETHOTREXATE
Named ingredient: Methotrexate
View registry recordMETHOTREXATE
Named ingredient: Methotrexate
View registry recordPREDNISONE
Named ingredient: Prednisone
View registry recordMETHOTREXATE
Named ingredient: Methotrexate
View registry recordMETHYLPREDNISOLONE
Named ingredient: Methylprednisolone
View registry recordETANERCEPT
Named ingredient: Etanercept
View registry recordSamodzielny Publiczny Szpital Kliniczny Nr 1 Im Prof. Tadeusza Sokolowskiego Pomorskiego Uniwersytetu Medycznego W Szczecinie
Szczecin, 71-252, Poland
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Warsaw, 02-637, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Warsaw, 02-507, Poland
Centrum Wsparcia Badań Klinicznych
First Submitted
March 5, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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SOLUTION FOR INJECTION
Formulated product
METHYLPREDNISOLONE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
ETANERCEPT
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
View registry recordFormulated product
METHYLPREDNISOLONE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
PREDNISONE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
FOLIC ACID
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
FOLIC ACID
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
METHOTREXATE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
METHOTREXATE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
METHOTREXATE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
PREDNISONE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
METHOTREXATE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
PREDNISONE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordMETHYLPREDNISOLONE
Named ingredient: Methylprednisolone
View registry recordPREDNISONE
Named ingredient: Prednisone
View registry recordFOLIC ACID
Named ingredient: Folic acid
View registry recordFOLIC ACID
Named ingredient: Folic acid
View registry recordMETHOTREXATE
Named ingredient: Methotrexate
View registry recordMETHOTREXATE
Named ingredient: Methotrexate
View registry recordMETHOTREXATE
Named ingredient: Methotrexate
View registry recordPREDNISONE
Named ingredient: Prednisone
View registry recordMETHOTREXATE
Named ingredient: Methotrexate
View registry recordPREDNISONE
Named ingredient: Prednisone
View registry recordContact the study team to confirm eligibility.
Szpital Specjalistyczny Im.J.Dietla W Krakowie
Cracow, 31-121, Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Warsaw, 04-141, Poland
Dolnoslaski Szpital Specjalistyczny Im. T.Marciniaka-Centrum Medycyny Ratunkowej
Wroclaw, 54-049, Poland