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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02620046
Registration number
NCT02620046
Ethics application status
Date submitted
19/11/2015
Date registered
2/12/2015
Date last updated
8/05/2024
Titles & IDs
Public title
A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease
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Scientific title
A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects With Ulcerative Colitis and Crohn's Disease
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Secondary ID [1]
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U1111-1168-0921
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Secondary ID [2]
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MLN0002SC-3030
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative
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Crohn's Disease
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Inflammatory bowel disease
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Inflammatory and Immune System
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0
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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0
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0
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Crohn's disease
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Oral and Gastrointestinal
0
0
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Vedolizumab SC
Experimental: Group A: Vedolizumab SC 108 mg Q2W - Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who:
Completed the Maintenance Period (Week 52), or
Were not randomized into Maintenance Period and achieved response at Week 14 after having received a third vedolizumab IV infusion at Week 6.
Experimental: Group B: Vedolizumab SC 108 mg QW - Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who withdrew early from the Maintenance Period due to treatment failure.
•Participants from current study who experience treatment failure while on study.
Treatment: Drugs: Vedolizumab SC
Vedolizumab SC 108 mg injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
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Assessment method [1]
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Number of TEAEs and SAEs adjusted by duration of exposure to study treatment scaled such that it provides an incidence rate of TEAEs and SAEs per 100-participant-years.
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Timepoint [1]
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From start of study medication through 18 weeks after the last dose
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Secondary outcome [1]
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Number of Adverse Events of Special Interest (AESIs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
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Assessment method [1]
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Number of AESIs adjusted by duration of exposure to study treatment scaled such that it provides an incidence rate of AESIs per 100-participant-years. AESIs include hypersensitivity reactions (including injections site reactions), serious infections, malignancies, hepatotoxicity (abnormal liver function test) and progressive multifocal leukoencephalopathy (PML).
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Timepoint [1]
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From start of study medication through 18 weeks after the last dose
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Secondary outcome [2]
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Percentage of Participants with Ulcerative Colitis Achieving Partial Mayo Scoring Clinical Response
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Assessment method [2]
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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 =1 point.
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Timepoint [2]
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From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years
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Secondary outcome [3]
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Percentage of Participants with Crohn's Disease Achieving Clinical Response
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Assessment method [3]
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Clinical response is defined as a decrease in HBI score 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]).
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Timepoint [3]
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From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years
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Secondary outcome [4]
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Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission
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Assessment method [4]
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Clinical remission is defined as a partial Mayo score of = 2 with no individual subscore >1.
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Timepoint [4]
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From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, up to 7 years
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Secondary outcome [5]
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Percentage of Participants with Crohn's Disease (CD) Achieving Clinical Remission
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Assessment method [5]
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Clinical remission is defined as total HBI score of =4 points in CD participants only (defined as randomized CD participants withdrawn from the parent study between Week 6 and Week 52).
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Timepoint [5]
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From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/04/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
21/06/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
746
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Nepean Hospital - Kingswood
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Mater Hospital Brisbane - South Brisbane
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Princess Alexandra Hospital - Woolloongabba
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Royal Adelaide Hospital - Adelaide
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Tennyson Centre Day Hospital - Kurralta Park
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Ballarat Base Hospital - Ballarat
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Monash Medical Centre Clayton - Bentleigh East
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St Vincent's Hospital Melbourne - Fitzroy
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St Frances Xavier Cabrini Hospital - Malvern
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Royal Melbourne Hospital - Melbourne
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The Alfred Hospital - Melbourne
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Fiona Stanley Hospital - Murdoch
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St John of God Subiaco Hospital - Subiaco
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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2747 - Kingswood
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4101 - South Brisbane
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4102 - Woolloongabba
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5000 - Adelaide
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5037 - Kurralta Park
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3350 - Ballarat
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Recruitment postcode(s) [8]
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3165 - Bentleigh East
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Recruitment postcode(s) [9]
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3065 - Fitzroy
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3144 - Malvern
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Recruitment postcode(s) [11]
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3000 - Melbourne
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Recruitment postcode(s) [12]
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3181 - Melbourne
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Recruitment postcode(s) [13]
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6150 - Murdoch
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Recruitment postcode(s) [14]
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6008 - Subiaco
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Recruitment outside Australia
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Louisiana
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Germany
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Berlin
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Eger
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Israel
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State/province [110]
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0
Hyogo-Ken
Query!
Country [111]
0
0
Japan
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State/province [111]
0
0
Iwate-Ken
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Kagawa-Ken
Query!
Country [113]
0
0
Japan
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State/province [113]
0
0
Kanagawa-Ken
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Okayama-Ken
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Osaka-Fu
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Saga-Ken
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Shiga-Ken
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Shizuoka-Ken
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Tokyo-To
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Country [120]
0
0
Japan
Query!
State/province [120]
0
0
Wakayama-Ken
Query!
Country [121]
0
0
Korea, Republic of
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State/province [121]
0
0
Gyeongsangbuk-do
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Country [122]
0
0
Korea, Republic of
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State/province [122]
0
0
Daegu
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Country [123]
0
0
Korea, Republic of
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State/province [123]
0
0
Seoul
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Country [124]
0
0
Lithuania
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State/province [124]
0
0
Kaunas
Query!
Country [125]
0
0
Lithuania
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State/province [125]
0
0
Klaipeda
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Country [126]
0
0
Lithuania
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State/province [126]
0
0
Vilnius
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Country [127]
0
0
Mexico
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State/province [127]
0
0
Guanajuato
Query!
Country [128]
0
0
Mexico
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State/province [128]
0
0
Jalisco
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Country [129]
0
0
Mexico
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State/province [129]
0
0
Nuevo Leon
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Country [130]
0
0
Mexico
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State/province [130]
0
0
Durango
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Country [131]
0
0
Mexico
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State/province [131]
0
0
Veracruz
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Country [132]
0
0
Netherlands
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State/province [132]
0
0
Amsterdam
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Country [133]
0
0
Netherlands
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State/province [133]
0
0
Dordrecht
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Country [134]
0
0
Netherlands
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State/province [134]
0
0
Groningen
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Country [135]
0
0
Netherlands
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State/province [135]
0
0
Maastricht
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Country [136]
0
0
Netherlands
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State/province [136]
0
0
Rotterdam
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Country [137]
0
0
Poland
Query!
State/province [137]
0
0
Bialystok
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Country [138]
0
0
Poland
Query!
State/province [138]
0
0
Bydgoszcz
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Country [139]
0
0
Poland
Query!
State/province [139]
0
0
Katowice
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Country [140]
0
0
Poland
Query!
State/province [140]
0
0
Krakow
Query!
Country [141]
0
0
Poland
Query!
State/province [141]
0
0
Lodz
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Country [142]
0
0
Poland
Query!
State/province [142]
0
0
Lublin
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Country [143]
0
0
Poland
Query!
State/province [143]
0
0
Szczecin
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Country [144]
0
0
Poland
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State/province [144]
0
0
Warszawa
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Country [145]
0
0
Poland
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State/province [145]
0
0
Wroclaw
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Country [146]
0
0
Romania
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State/province [146]
0
0
Bucuresti
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Country [147]
0
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Romania
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State/province [147]
0
0
Timisoara
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Country [148]
0
0
Russian Federation
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State/province [148]
0
0
Kazan
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Country [149]
0
0
Russian Federation
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State/province [149]
0
0
Krasnoyarsk
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Country [150]
0
0
Russian Federation
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State/province [150]
0
0
Moscow
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Country [151]
0
0
Russian Federation
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State/province [151]
0
0
Novosibirsk
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Country [152]
0
0
Russian Federation
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State/province [152]
0
0
Omsk
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Country [153]
0
0
Russian Federation
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State/province [153]
0
0
Rostov-on-Don
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Country [154]
0
0
Russian Federation
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State/province [154]
0
0
Saint-Petersburg
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Country [155]
0
0
Russian Federation
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State/province [155]
0
0
Sestroretsk
Query!
Country [156]
0
0
Russian Federation
Query!
State/province [156]
0
0
St. Petersburg
Query!
Country [157]
0
0
Serbia
Query!
State/province [157]
0
0
Belgrade
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Country [158]
0
0
Serbia
Query!
State/province [158]
0
0
Kragujevac
Query!
Country [159]
0
0
Serbia
Query!
State/province [159]
0
0
Nis
Query!
Country [160]
0
0
Serbia
Query!
State/province [160]
0
0
Novi Sad
Query!
Country [161]
0
0
Slovakia
Query!
State/province [161]
0
0
Banska Bystrica
Query!
Country [162]
0
0
Slovakia
Query!
State/province [162]
0
0
Bratislava
Query!
Country [163]
0
0
Slovakia
Query!
State/province [163]
0
0
Kosice
Query!
Country [164]
0
0
Slovakia
Query!
State/province [164]
0
0
Nitra
Query!
Country [165]
0
0
Slovakia
Query!
State/province [165]
0
0
Presov
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Country [166]
0
0
South Africa
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State/province [166]
0
0
Gauteng
Query!
Country [167]
0
0
South Africa
Query!
State/province [167]
0
0
Western Cape
Query!
Country [168]
0
0
Spain
Query!
State/province [168]
0
0
Barcelona
Query!
Country [169]
0
0
Spain
Query!
State/province [169]
0
0
Madrid
Query!
Country [170]
0
0
Spain
Query!
State/province [170]
0
0
Alicante
Query!
Country [171]
0
0
Spain
Query!
State/province [171]
0
0
Girona
Query!
Country [172]
0
0
Spain
Query!
State/province [172]
0
0
Pontevedra
Query!
Country [173]
0
0
Sweden
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State/province [173]
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0
Stockholm
Query!
Country [174]
0
0
Taiwan
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State/province [174]
0
0
Taipei
Query!
Country [175]
0
0
Turkey
Query!
State/province [175]
0
0
Ankara
Query!
Country [176]
0
0
Turkey
Query!
State/province [176]
0
0
Istanbul
Query!
Country [177]
0
0
Turkey
Query!
State/province [177]
0
0
Kocaeli
Query!
Country [178]
0
0
Turkey
Query!
State/province [178]
0
0
Mersin
Query!
Country [179]
0
0
Ukraine
Query!
State/province [179]
0
0
Chernivtsi
Query!
Country [180]
0
0
Ukraine
Query!
State/province [180]
0
0
Dnipro
Query!
Country [181]
0
0
Ukraine
Query!
State/province [181]
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0
Ivano-Frankivsk
Query!
Country [182]
0
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Ukraine
Query!
State/province [182]
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0
Kharkiv
Query!
Country [183]
0
0
Ukraine
Query!
State/province [183]
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0
Kherson
Query!
Country [184]
0
0
Ukraine
Query!
State/province [184]
0
0
Kyiv
Query!
Country [185]
0
0
Ukraine
Query!
State/province [185]
0
0
Lviv
Query!
Country [186]
0
0
Ukraine
Query!
State/province [186]
0
0
Odesa
Query!
Country [187]
0
0
Ukraine
Query!
State/province [187]
0
0
Ternopil
Query!
Country [188]
0
0
Ukraine
Query!
State/province [188]
0
0
Vinnytsia
Query!
Country [189]
0
0
Ukraine
Query!
State/province [189]
0
0
Zaporizhzhia
Query!
Country [190]
0
0
United Kingdom
Query!
State/province [190]
0
0
Devon
Query!
Country [191]
0
0
United Kingdom
Query!
State/province [191]
0
0
Greater London
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Country [192]
0
0
United Kingdom
Query!
State/province [192]
0
0
Norfolk
Query!
Country [193]
0
0
United Kingdom
Query!
State/province [193]
0
0
Shropshire
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Country [194]
0
0
United Kingdom
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State/province [194]
0
0
West Midlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Takeda
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The main aim of the study is to check for long-term side effects of Vedolizumab Subcutaneous
(also known as Vedolizumab SC) in people with ulcerative colitis and Crohn's disease.
Vedolizumab SC will be given as an injection just under the skin. This type of injection is
called a subcutaneous injection or SC for short. Another aim of the study is to collect
information on whether the participant's condition remains under control or improves during
and after treatment with Vedolizumab SC.
Participants who previously took part in studies MLN0002SC-3027 or MLN0002SC-3031 will be
invited to visit the study clinic. At this visit, the study doctor will check if each
participant can take part in this study.
For those who can take part, participants will receive a subcutaneous injection of
vedolizumab SC either once a week or once every 2 weeks. How often each participant receives
vedolizumab SC will depend on their results from the previous study and on how active their
condition is. Participants might be able to self-inject vedolizumab SC after being trained by
the study doctors. During this study, the dose of vedolizumab SC might be increased for
participants whose condition worsens.
Participants will continue treatment with vedolizumab SC until it is approved in their
particular country, the participant decides to stop treatment, or the sponsor stops the
study. If the sponsor stops the study before vedolizumab SC is approved in all countries, the
sponsor will make sure all affected participants will have access to vedolizumab SC outside
of the study.
After their final dose of vedolizumab SC, participants will visit the clinic 18 weeks later
for a final check-up. Then, the clinic will telephone the participants 6 months after their
final dose of vedolizumab SC to check if they have any health problems.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02620046
Query!
Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Medical Director Clinical Science
Query!
Address
0
0
Takeda
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
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Phone
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Fax
0
0
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Email
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02620046
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