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Brazikumab low dose for Crohn's Disease (INTREPID Trial)
INTREPID Trial Summary
This trial will study the safety and effectiveness of a new drug, brazikumab, for Crohn's Disease. It will compare it to placebo and an active comparator drug. The trial will assess clinical response and colonic mucosal appearance.
- Crohn's Disease
- Inflammatory Bowel Disease
INTREPID Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.INTREPID Trial Design
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Who is running the clinical trial?
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- You have had cancer in the past, but certain types of cancer may be allowed.You are currently dependent on a special liquid diet or IV nutrition.You have received a bone marrow or organ transplant in the past.Qualifications for being eligible to participate in the study.You have had an allergic reaction to the study drug or any of its ingredients, or other similar treatments.You had a serious colon problem called toxic megacolon within the last 3 months.You have a hole between your intestines and your skin or bladder.You have had or currently have certain medical conditions related to your digestive system.You have a medical condition that makes you more likely to get an infection, such as HIV, or have had your spleen removed.You have had significant heart problems within the past 6 months.You have Crohn's disease and are currently experiencing severe complications such as a blocked intestine or pre-surgery anticipation within the next 6 months.You have been experiencing symptoms of Crohn's disease in your small or large intestine for at least 3 months before being screened for the trial.You have other medical conditions that are not related to CD and cannot be controlled with standard treatment.You have a history of long-term use of painkillers or drugs and/or alcohol abuse.You have not responded well to standard or previous treatments for your condition, or you have become dependent on corticosteroids to manage your symptoms.
- Group 1: (Stage 1) Brazikumab high dose
- Group 2: (Stage 1) Brazikumab low dose
- Group 3: (Stage 1) Placebo
- Group 4: (Stage 2) Brazikumab high dose
- Group 5: (Stage 2) Brazikumab low dose
- Group 6: (Stage 2) Humira®
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Could you explain the age requirements for this clinical trial?
"The age limit for participants in this clinical trial is 18-80 years old."
Are patient applications being accepted at this time?
"The listed clinical trial on clinicaltrials.gov is currently looking for volunteers. The details of the study were first posted on December 7th, 2018 with the most recent update being October 18th, 2022."
How can I join this trial?
"928 individuals with a documented diagnosis of Crohn's disease will be admitted into this clinical trial. Patients must meet the following inclusion criteria: ____."
How many different staff locations are managing this trial?
"26 medical centres are participating in this clinical trial, with locations spanning from Spokane to Chicoutimi. If you're interested in enrolling, please consider a location close to you to limit travel requirements."
What are the common indications for Brazikumab low dose?
"Brazikumab low dose is commonly used to treat ankylosing spondylitis. This medication can also help patients with rheumatoid arthritis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis."
Are there any other Brazikumab trials with different dosages?
"Brazikumab low dose was first trialled over a decade ago in 2007, at University of Nebraska Medical Center. Since that time, there have been 18534 completed clinical trials worldwide. There are 55 active studies recruiting patients as of now; many of these are based in Spokane, Washington."
How many study participants are currently enrolled?
"This is accurate. The clinicaltrials.gov website has the latest information on this study, which began recruiting on December 7th, 2018. So far 928 people have signed up at 26 different locations nationwide."
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