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Trial · NCT03532932

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CDFrom 2 years before enrollment up to Month 12 after enrollment (up to 3 years)FAS included those participants who signed the informed consent form and were analyzed in the study.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Stratified by Location of DiseaseWithin 1 year prior to Baseline (Visit 1)
FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Stratified by Disease SeverityAt Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period
FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified visits.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine PracticeFrom Baseline Visit (Day 1) up to 12 monthsFAS included those participants who signed the informed consent form and were analyzed in the study.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Assessments Using Different Methods in Participants With UC and CD Disease ActivityFrom Baseline Visit (Day 1) up to 12 monthsFAS included those participants who signed the informed consent form and were analyzed in the study.assessmentsMEAN
SECONDARYUC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo IndexAt Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective periodFAS included those participants who signed the informed consent form and were analyzed in the study.percentage of participantsNUMBER
SECONDARYCD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBIAt Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective periodFAS included those participants who signed the informed consent form and were analyzed in the study.percentage of participantsNUMBER
SECONDARYNumber of Participants With at Least One Episode of Failure of Biological or Non-biological TherapyFrom 2 years before enrollment up to Month 12 after enrollment (up to 3 years)FAS included those participants who signed the informed consent form and were analyzed in the study.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Who Needed Treatment Adjustments Based on Disease Activity AssessmentFrom 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPercentage of Participants Stratified by Achieving the Treatment GoalsFrom 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories.
percentage of participantsNUMBER
SECONDARYPercentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical PracticeFrom 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure.
percentage of participantsNUMBER
SECONDARYPercentage of Participants Based on Hospitalizations Due to Complications, IBD Related Surgeries, and Disability Determination in Participants With Moderate to Severe UC and CDFrom 2 years before enrollment up to Month 12 after enrollment (up to 3 years)FAS included those participants who signed the informed consent form and were analyzed in the study.percentage of participantsNUMBER
SECONDARYPercentage of Participants Based on Surgical Treatment by Indications and Type of SurgeriesFrom 2 years before enrollment up to Month 12 after enrollment (up to 3 years)FAS included those participants who signed the informed consent form and were analyzed in the study. Here, number analyzed signifies participants who were evaluable for given categories.percentage of participantsNUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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