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NCT04779320RECRUITINGIRB Ready

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

Sponsored by Takeda

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 120 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks.

Who Can Participate

Inclusion Criteria

The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC). 2. The participants weigh โ‰ฅ10 kg at the time of screening and enrollment into the study. 3. Participants with Crohn's disease (CD) diagnosed at least 1 month before screening. Participants with moderately to severely active CD defined by a Pediatric Crohn's Disease Activity Index (PCDAI) \>30 and an simple endoscopic score for Crohn's Disease (SES-CD) \>6 (or an SES-CD โ‰ฅ4 if disease is confined to terminal ileum) at screening endoscopy. 4. Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate \[MTX\]), and/or tumor necrosis factor (TNF)-ฮฑ antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids or exclusive or partial en

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

120 participants

๐ŸŽ‚

Age Range

2 Years - 17 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Takeda

Study Locations

Choose your preferred location or select flexible during enrollment

NOT_YET_RECRUITING

Phoenix

Arizona

Location available
View Phoenix location page
WITHDRAWN

Los Angeles

California

Location available
View Los Angeles location page
NOT_YET_RECRUITING

San Diego

California

Location available
View San Diego location page
WITHDRAWN

San Francisco

California

Location available
View San Francisco location page
WITHDRAWN

Kissimmee

Florida

Location available
View Kissimmee location page
RECRUITING

Atlanta

Georgia

Location available
View Atlanta location page
RECRUITING

Park Ridge

Illinois

Location available
View Park Ridge location page
WITHDRAWN

Indianapolis

Indiana

Location available
View Indianapolis location page
NOT_YET_RECRUITING

Baltimore

Maryland

Location available
View Baltimore location page

๐Ÿ“ And 13 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Crohn's Disease Treatment in Phoenix?

Join others in Arizona exploring innovative treatment options through clinical research

Crohn's Disease Treatment Options in Phoenix, Arizona

If you're searching for Crohn's Disease treatment in Phoenix, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Phoenix, Los Angeles, San Diego and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Crohn's Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 120 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Crohn's Disease?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Crohn's Disease

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Crohn's Disease Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04779320. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.