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Monoclonal Antibodies

Vedolizumab for Crohn's Disease

Phase 4
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 10, 14, 26, 52, 78 and 102
Awards & highlights

Study Summary

This study is evaluating whether a combination of medications can help treat CD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 10, 14, 26, 52, 78 and 102
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 10, 14, 26, 52, 78 and 102 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Achieving Endoscopic Remission at Week 26
Secondary outcome measures
Change From Baseline in C-reactive Protein (CRP) Levels at Weeks 10 and 26
Change From Baseline in Fecal Calprotectin Concentrations at Weeks 10, 14, 26, 52, 78, and 102
Change From Baseline in SES-CD Score at Week 26
+16 more

Side effects data

From 2019 Phase 4 trial • 11 Patients • NCT02559713
9%
Crohn's disease
9%
Gastrointestinal motility disorder
9%
Paronychia
9%
Viral infection
9%
Colitis ulcerative
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vedolizumab 300 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)Experimental Treatment3 Interventions
In Triple Combination Therapy Phase, vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2, 6, 14 and 22, with adalimumab 160 mg subcutaneously (SC), once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34. In Monotherapy Phase, vedolizumab 300 mg IV infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vedolizumab
2009
Completed Phase 4
~10330
Adalimumab
2013
Completed Phase 4
~6480
Methotrexate
2013
Completed Phase 4
~3800

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,205 Previous Clinical Trials
4,187,914 Total Patients Enrolled
Medical Director Clinical ScienceStudy DirectorTakeda
197 Previous Clinical Trials
63,192 Total Patients Enrolled
Medical DirectorStudy DirectorTakeda
2,777 Previous Clinical Trials
8,064,349 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Triple Combination Therapy in High Risk Crohn's Disease (CD)
2017. "Triple Combination Therapy in High Risk Crohn's Disease (CD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02764762.
~7 spots leftby May 2025
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