The main objectives of this study are to evaluate the long-term safety of spesolimab in patients with perianal fistulising Crohn's disease who have completed treatment in parent trials and to evaluate the long-term efficacy of spesolimab in patients with perianal fistulising Crohn's disease, who have completed treatment in parent trials
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Spesolimab
AKH - Medical University of Vienna
Vienna, Austria
UZ Leuven
Leuven, Belgium
Centre Hospitalier Universitaire de Liège
Liège, Belgium
Universitätsklinikum Erlangen
Erlangen, Germany
Exposure Adjusted Rate of Patients Reporting a Treatment Emergent Adverse Event (TEAE) During Maintenance Treatment
Exposure adjusted rate of patients reporting a treatment emergent adverse event (TEAE) during maintenance treatment. The incidence rate was calculated as Incidence rate = 100 \* number of patients with TEAE / Total TEAE-specific time at risk. Where the Time at risk (for patients who experienced a TEAE) was calculated as Time at Risk (in subject years) = ((date of onset of AE - study drug start date) +1 day) / 365.25 and Time at risk (for patients who did not experience a TEAE) Time at Risk (in subject years) = ((date of the end of time at risk - study drug start date) +1 day) / 365.25.
Time frame: First dose of Spesolimab in this trial through to the last dose of spesolimab + 16 weeks, approximately 104 weeks.
Proportion of Patients With Perianal Fistula Remission
Proportion of patients with perianal fistula remission at weeks 48 and 96. Perianal fistula remission was defined as closure of all external openings, i.e. no drainage and discharge despite gentle finger compression, that were open and draining at baseline of the parent trial and closure of all external openings that were newly emerged during the parent trial or this trial.
Time frame: Baseline, week 48 and 96 of treatment.
Proportion of Patients With Perianal Fistula Response
Proportion of patients with perianal fistula response at weeks 48 and 96. Perianal fistula response was defined as closure and no drainage and discharge despite gentle finger compression of at least 50% in number of external openings regardless of the onset time, compared with the number of open and drainage fistulas at baseline of the parent trial.
Time frame: Baseline, week 48 and 96 of treatment.
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Universitätsklinikum Ulm
Ulm, Germany
Amsterdam UMC, Locatie AMC
Amsterdam, Netherlands
Inje University Haeundae Paik Hospital
Busan, South Korea