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

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Takeda
Study ID
NCT02764762
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Vedolizumab — DRUG
    Vedolizumab intravenous infusion.
  • Adalimumab — DRUG
    Adalimumab injection for subcutaneous use.
  • Methotrexate — DRUG
    Methotrexate oral tablets.

Study Details

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.

Key Dates

Start date
Apr 18, 2017
Status verified
Jun 2023
Primary completion
Sep 22, 2020
Completion
Jul 5, 2022

Study Design

Enrollment
55 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vedolizumab 300 mg (IV) + Adalimumab 160-80-40 mg (SC) + Methotrexate 15 mg (Oral)
    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.

Primary Outcome Measure

Percentage of Participants Achieving Endoscopic Remission at Week 26 [ Time Frame: Week 26 ]

Locations (27)

FacilityCityStateZIPSite coordinators
Digestive Health Specialists of the SoutheastDothanAlabama36305-
Gastro FloridaClearwaterFlorida33761-
Atlanta Gastroenterology AssociatesAtlantaGeorgia30342-5000-
Grand Teton Research Group, PLLCIdaho FallsIdaho83404-
Northshore University HealthSystemEvanstonIllinois60201-
University of Kansas Medical CenterKansas CityKansas66160-
Cotton O'Neil Clinical ResearchTopekaKansas66606-
Texas Digestive Disease Consultants Baton RougeBaton RougeLouisiana70809-
Louisana Research Center, LLCShreveportLouisiana71105-
Center for Digestive HealthTroyMichigan48098-
Huron Gastroenterology AssociatesYpsilantiMichigan48197-
Minnesota Gastroenterology, PA - PlymouthPlymouthMinnesota55446-
University of Mississippi Medical CenterJacksonMississippi39216-
Las Vegas Medical ResearchLas VegasNevada89113-
Icahn School of Medicine at Mt. SinaiNew YorkNew York10029-
Digestive Health Partners, PSAshevilleNorth Carolina28801-
Carolinas HealthCare System Digestive HealthCharlotteNorth Carolina28204-
The Ohio State University Wexner Medical CenterColumbusOhio43210-
Digestive Disease Specialists, Inc.Oklahoma CityOklahoma73112-
Options Health Research, LLCTulsaOklahoma74104-
Baylor College of MedicineHoustonTexas77030-
Pinnacle Clinical ResearchSan AntonioTexas78229-
Texas Digestive Disease Consultants SouthlakeSouthlakeTexas76092-
Tyler Research Institute, LLCTylerTexas75701-
Texas Digestive Disease Consultants, WebsterWebsterTexas77598-
University of Utah Health Sciences CenterSalt Lake CityUtah84132-
Digestive Health SpecialistsTacomaWashington98405-

Find similar trials in Dothan, AL

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Digestive Health Specialists of the Southeast· Dothan, ALGastro Florida· Clearwater, FLAtlanta Gastroenterology Associates· Atlanta, GAGrand Teton Research Group, PLLC· Idaho Falls, IDNorthshore University HealthSystem· Evanston, ILUniversity of Kansas Medical Center· Kansas City, KS

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