Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
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|ClinicalTrials.gov Identifier: NCT03196427|
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : October 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis Crohn's Disease||Drug: Vedolizumab||Phase 2|
The drug being tested in this study is called Vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active UC or CD.
This study will look at the long-term safety profile in participants who take vedolizumab IV. Participants will be randomly assigned (by chance, like flipping a coin) which will remain undisclosed to the participant and investigator during this double blind study (up to Week 40) maintaining the dose at study entry and escalating the dose at disease worsening.
The dosing regimen selected for the long-term study is intended to maintain clinical response at the lowest possible exposure.
At the discretion of the investigator, participants receiving the low dose (150 or 100 mg) of vedolizumab IV may be escalated to the high dose (300 or 200 mg) if the participants demonstrate disease worsening at 2 consecutive visits (scheduled or unscheduled).
Participants who experience continued disease worsening during the study despite being administered vedolizumab 300 or 200 mg every 8 weeks (Q8W) will be discontinued from the study.
Study duration is expected to be up to 5 years, depending on the enrollment rate in the previous randomized double blind study (MLN0002-2003).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease|
|Actual Study Start Date :||July 30, 2018|
|Estimated Primary Completion Date :||February 8, 2025|
|Estimated Study Completion Date :||June 14, 2025|
Experimental: Vedolizumab High Dose Group
Participants with UC or CD having baseline weight of greater than or equal to (>=) 30 kilogram (kg) will receive Vedolizumab 300 milligram (mg) and participants with UC or CD having baseline weight of less than (<) 30 kg will receive Vedolizumab 200 mg, intravenous infusion, every 8 weeks for up to 5 years.
Vedolizumab intravenous infusion.
Experimental: Vedolizumab Low Dose Group
Participants with UC or CD having baseline weight of >= 30 kg will receive Vedolizumab 150 mg and participants with UC or CD having baseline weight of < 30 kg will receive Vedolizumab 100 mg intravenous infusion, every 8 weeks for up to 5 years.
Vedolizumab intravenous infusion.
- Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to 5 years ]An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
- Time to Major Inflammatory Bowel Disease (IBD) - Related Events [ Time Frame: Baseline up to 5 years ]Major IBD-related events included hospitalizations, surgeries, or procedures due to UC and CD.
- Change from Baseline in IMPACT-III Total and Subscale Scores at Week 24 and Every 24 weeks, Thereafter up to 5 years [ Time Frame: Baseline up to 5 years ]The IMPACT-III questionnaire is a self-reported measure with 35 closed questions encompassing 6 domains: Bowel Symptoms (7 items), Systemic Symptoms (3 items), Social Functioning (12 items), Body Image (3 items), Treatment/Interventions (3 items), and Emotional Functioning (7 items). The IMPACT-III uses a 5-point Likert scale ranging from 1 to 5 for all answers. The outcome score ranges from 35 to 175, with higher scores suggesting better quality of life.
- Height Velocity at Week 48 and Every 48 weeks, Thereafter up to 5 years [ Time Frame: Baseline up to 5 years ]Height velocity (cm/year) is the change in height per year.
- Change from Baseline in Height at Week 24 and Every 24 Weeks, Thereafter up to 5 years [ Time Frame: Baseline up to 5 years ]
- Change from Baseline in Weight at Week 24 and Every 24 Weeks, Thereafter up to 5 years [ Time Frame: Baseline up to 5 years ]
- Change from Baseline in Body Mass Index (BMI) at Week 24 and Every 24 Weeks, Thereafter up to 5 years [ Time Frame: Baseline up to 5 years ]BMI = Weight (in kilograms)/height^2 (in meters).
- Percentage of Participants Achieving Tanner Stage V Scale [ Time Frame: Baseline up to 5 years ]Tanner Stage Evaluation is a scale used to evaluate growth parameters standardized for age, sex, and pubertal development. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Tanner stage is assessed at or before age 16 years for females or 17 years for males.
- Percentage of Participants With UC Meeting Complete Mayo Score Response at Week 32 [ Time Frame: Week 32 ]Clinical response is defined as a continued reduction in complete mayo score of >=3 points from baseline (at initiation of MLN0002-2003) and continued decrease in rectal bleeding subscore of >=1 point from baseline, or absolute rectal bleeding subscore of <=1 point. Mayo score is an instrument designed to measure disease activity of UC. It consists of 4 subscores: stool frequency, rectal bleeding, findings on endoscopy and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12; where higher scores indicate more severe disease.
- Percentage of Participants With CD Meeting 50 Percent (%) Reduction in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 32 [ Time Frame: Week 32 ]Clinical response is defined as a 50% reduction in SES-CD score on endoscopy compared to the baseline endoscopy (at initiation of MLN0002-2003) and continued reduction in CDAI that is a >=70 point decrease from the baseline Crohn's disease activity index (CDAI) score at the initiation of MLN0002-2003. CDAI is a research tool used to quantify the symptoms of participants with Crohn's disease. SES-CD consists of 3 variables: ulcer size, ulcerated and affected surfaces and presence of narrowing each graded from 0 to 3 with score of 0 means no colonic lesions or mucosal healing, and SES-CD greater than (>) 1 indicates the presence of mucosal lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196427
|Contact: Takeda Study Registration Call Centerfirstname.lastname@example.org|
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|Study Director:||Medical Director||Takeda|