SYFce04302bcdc74d5ea9c8121d1c0c3fc2Registry ID: 2024-513299-17-00|RecruitingPhase 4
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interventional
N/A
1 country
4
The aim is to identify clinical and biological markers that offer guidance as to which patients successfully may discontinue maintenance anti-TNF treatment, and which patients on the contrary need to continue treatment over an extended period of time in order to remain in remission.
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.
August 28, 2024
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The proportion of patients that relapses, as defined by symptomatic scoring in combination with endoscopy, at 12 and 24 months after discontinuation of anti-TNF treatment with identification of factors at study-start that correlate positively or negatively with the event of relapse.
Endoscopic scores at 12 and 24 months among those who relapsed compared to those who remained in remission.
Fecal calprotectin levels at 12 and 24 months among those who relapsed compared to those who remained in remission.
Fecal calprotectin levels at study start among ulcerative colitis patients who relapsed compared to those who remained in remission.
The rate of relapse among ulcerative colitis patients with the following fecal calprotectin level ranges (<30 mg/kg for Calpro [C] and <60 mg/kg for Buhlmann [B]; 30-99 mg/kg C and 60-199 mg/kg B; 100-299 mg/kg C and 200-599 mg/kg B; ≥300 mg/kg C and ≥600 mg/kg B.
The optimal fecal calprotectin level cut-off with regards to sensitivity and specificity for relapse, for ulcerative colitis and Crohn's disease patients, respectively.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Remicade 100 mg powder for concentrate for solution for infusion.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
Remsima 100 mg powder for concentrate for solution for infusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
Inflectra 100 mg powder for concentrate for solution for infusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
Humira 40 mg/0.8 ml solution for injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Remicade 100 mg powder for concentrate for solution for infusion.
Named ingredient: Infliximab
View registry recordRemsima 100 mg powder for concentrate for solution for infusion
Named ingredient: Infliximab
View registry recordInflectra 100 mg powder for concentrate for solution for infusion
Named ingredient: Infliximab
View registry recordHumira 40 mg/0.8 ml solution for injection
Named ingredient: Adalimumab
View registry recordKarolinska University Hospital
Solna, 171 64, Sweden
Region Skane Kristianstad Central Hospital
Kristianstad, 291 33, Sweden
Region Skane Skanes Universitetssjukhus
Malmo, 214 28, Sweden
Jan Marsal
First Submitted
August 28, 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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Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Region Oestergoetland
Linkoping, 58185, Sweden