Ulcerative colitis or Crohn's disease
Conditions
Interventions
Group B: Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who withdrew early from the Maintenance Period due to treatment failure, or Participants from current study who experience treatmen
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Prior participation in Study MLN0002SC-3027 or MLN0002SC-3031, and, in the opinion of the investigator, tolerated the study drug well. Early withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 must have been due to treatment failure during the Maintenance Period.
Exclusion criteria
Exclusion criteria: 1. Surgical intervention for IBD during or after participation in Study MLN0002SC-3027 or MLN0002SC-3031, or at any time during this study. 2. Chronic or severe infection, or, any new, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurologic, oncologic, or other medical disorder developed during or after participation in a prior vedolizumab study that, in the opinion of the investigator, would confound the study results or compromise participant safety. 3. Withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 due to a study-drug related adverse event (AE).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number of Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment Time Frame: Up to 97.9 months A TEAE was defined as an adverse event (AE) that started or worsened on or after study Day 1 (defined as day first dosed) and no more than 18 weeks after the last dose of study drug. An SAE was defined as any untoward medical occurrence that occurs at any dose and resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event such as acute liver failure, pulmonary hypertension, or confirmed or suspected transmission of an infectious agent by a medicinal product. Participant years is defined as the total exposure-time of the participants in the respective treatment group. Incidence per 100 participant years is defined as (Number of participants with events*100/participant years). As per planned analysis, data for this outcome measure is grouped and presented per disease condition. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Number of Adverse Events of Special Interest (AESIs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment Time Frame: Up to 97.9 months AESIs included hypersensitivity reactions (including injections site reactions), serious infections, malignancies, hepatotoxicity (abnormal liver function test) and progressive multifocal leukoencephalopathy (PML). Participant years is defined as the total exposure-time of the participants in the respective treatment group. Incidence per 100 participant years is defined as (Number of participants with events*100/participant years). As per planned analysis, data for this outcome measure is grouped and presented per disease condition. 2.Number of Participants With Ulcerative Colitis Achieving Partial Mayo Scoring Clinical Response at Week 48 Time Frame: Week 48 Clinical response is defined as a decrease in the partial Mayo score of at least 2 points and >=25% from baseline, with an accompanying decrease in rectal bleeding subscore of >=1 point from baseline or absolute rectal bleeding subscore of ==3 points from baseline in CD participants (randomized early terminator CD participants only [defined as randomized CD participants withdrawn from the parent study between Week 6 and Week 52]). As per planned analysis, data for this outcome measure is grouped and presented for participants with Crohn's disease. 4.Number of Participants With Ulcerative Colitis Achieving Clinical Remission Based on Partial Mayo Score Time Frame: Week 48 Clinical remission is defined as a partial Mayo score of =1. As per planned analysis, data for this outcome measure is grouped and presented for participants with ulcerative colitis. 5.Number of Participants With Crohn's Disease Achieving Clinical Remission Based on Harvey-Bradshaw Index (HBI) Scores Time Frame: Week 48 Clinical remission is defined as total HBI score of =<4 points. As per planned analysis, data for this outcome measure is grouped and presented for participants | — |
Countries
Japan, Refer to "Other"section
Contacts
Public ContactContact for Clinical Trial Information
Takeda Pharmaceutical Company Limited
Outcome results
None listed