NCT02764762

Triple Combination Therapy in High Risk Crohn's Disease (CD)

An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing Complications

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effect of triple combination therapy with an anti-integrin (vedolizumab intravenous \[IV\]), a tumor necrosis factor (TNF) antagonist (adalimumab subcutaneously \[SC\]), and an immunomodulator (oral methotrexate) on endoscopic remission in participants with newly-diagnosed CD stratified at higher risk for complications.

Detailed description

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have CD. This study will look at the endoscopic remission and mucosal healing of gastrointestinal tract of people who take vedolizumab as triple combination therapy with adalimumab and methotrexate. The study will enroll approximately 60 participants. Participants will receive triple combination therapy which includes: * Vedolizumab 300 mg (intravenous) * Adalimumab 160/80/40 mg (subcutaneous) * Methotrexate 15 mg (oral) All participants will receive vedolizumab intravenous infusion on Weeks 0, 2, 6, 14 and 22 along with adalimumab 160 mg, subcutaneous injection at Week 0, 80 mg at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with methotrexate tablets orally, once weekly from Weeks 0 up to Week 34. In monotherapy phase, all participants will receive vedolizumab intravenous infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102. This multi-center trial will be conducted in the United States and Canada. The overall time to participate in this study is 128 weeks. Participants will make multiple visits to the clinic, plus a final visit 18 weeks after last dose of study drug for a safety follow-up assessment. Participants will also participate in a long-term safety questionnaire, by phone, at 26 weeks (6 months) from the last dose of study drug.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	Vedolizumab	Vedolizumab intravenous infusion.
DRUG	Adalimumab	Adalimumab injection for subcutaneous use.
DRUG	Methotrexate	Methotrexate oral tablets.

Timeline

• Start date: 2017-04-18
• Primary completion: 2020-09-22
• Completion: 2022-07-05
• First posted: 2016-05-06
• Last updated: 2023-07-14
• Results posted: 2021-10-21

Locations

32 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study