Contact the organisation Opens in new window. Administrative Contact. Participants 9 Sort alphabetically. Sort by EU Contribution. Expand all. Via Cracovia 50 Roma. United Kingdom. Volgina 7 Beograd. Trippstadter Strasse Kaiserslautern. Piazzale Aldo Moro 7 Roma. Via Val Di Sole 22 Milano. Private for-profit entities excluding Higher or Secondary Education Establishments. Frank Kirchner. University of Strathclyde, Ph. Massimiliano Vasile. Marko Jankovic. Robotic technologies for the removal of space debris Innovatice technologies for relative navigation and capture Information Technology for Maritime Applications From Week 48, participants will continue ustekinumab treatment in the study extension period, up to Week Dosing frequency will be adjusted in the extension period for the participants failing to meet the treatment target.
At Week 8, all participants will receive a 90 mg SC injection of ustekinumab. During the routine care maintenance treatment period, in case of clinical worsening reported by the participant, consistent with disease flare in the investigator's judgment, clinical assessments of disease flare will be performed at the investigator's discretion. Experimental: Routine Care Arm In the routine care arm, assessment visits will be scheduled according to the timing of maintenance treatment injections up to Week 48, which will be in compliance with the EU SmPC for ustekinumab for the treatment of Crohn's disease, in which dosing every 12 weeks is recommended.
Nonetheless, participants who have not shown adequate response based on the investigator's judgment may receive a second SC dose at Week Participants meeting target will continue with same UST dosing frequency. The dosing frequency will be optimized for all participants failing to meet the target at assessment visit.
Those previously on Q12 regimens will be adjusted to Q8 dosing; those previously on Q8 regimens will be adjusted to Q4 dosing. Participants subsequently failing to meet the target will not be able to adjust further and will leave the study. Participants receiving 12 weekly dosing frequency Q12 ustekinumab will maintain this dosing frequency. Participants with either clinical remission or endoscopic remission, but not both, at Week 48 will continue with same dosing frequency or de-escalate provided maintenance of corticosteroid-free clinical remission and biomarker remission at 2 consecutive visits.
Participants with neither corticosteroid-free clinical remission nor endoscopic remission will escalate dose or leave study if already on 4 weekly dosing frequency Q4 dose.
If neither clinical remission nor biomarker remission is evident at the next visit, participant will leave study. Later in the extension period, only those who achieve corticosteroid-free clinical remission and biomarker remission will undergo dose de-escalation.
SES-CD is a validated instrument reflecting an endoscopist global appraisal of mucosal lesions in Crohn's disease. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum.
Scores range from 0 to 60, with higher scores indicating more severe disease. Randomized participants who stop treatment before reaching Week 48 due to any reason, or participants without endoscopic data at Week 48 were analyzed as nonresponders.
SES-CD is a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions in Crohn's disease. Participants with missing data were analyzed as non-responder. A decrease in CDAI over time indicates improvement in disease activity. Participants with missing data were analyzed as non-remitter. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
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