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Is Crohn's Disease Disrupting Your Daily Life?
Answer a few questions to see if you qualify for a clinical trial for people living with Crohn's Disease.
Short Summary
Medical Condition:
Crohn’s Disease
Participation duration:
Approximately 1 year
Phase:
2
What is Crohn’s Disease?
Crohn's disease is a chronic inflammatory condition of the digestive tract, primarily affecting the small intestine and colon. It causes symptoms like abdominal pain, diarrhoea, fatigue, and weight loss. The exact cause is unknown, but it is believed to involve an abnormal immune response, genetics, and environmental factors. While there's no cure, treatment focuses on managing symptoms and reducing inflammation through medication, lifestyle changes, or surgery.
What is the SPECIFI-CD Crohn’s clinical study?
The study aims to evaluate if an experimental medicine, also called an investigational study drug, can improve signs and symptoms of moderate to severe Crohn’s disease (CD). It works by blocking something called Tumour Necrosis factor receptor (TNFR1) signaling, which is overactive in Crohn's disease and causes inflammation. By stopping this, the drug can reduce inflammation and symptoms.
SPECIFI-CD is a randomized, double-blind, placebo-controlled study. A computer will randomly assign participants to study drug arms or the placebo arm. Double-blind means neither you nor your study doctor will know which treatment you are receiving. The placebo looks like the study drug but contains no medication.
Who can participate?
To participate you must:
Be aged between 18 and 75 years
Have been diagnosed with Crohn’s disease for at least 3 months
Have currently active, moderate to severe disease
What happens if I participate?
The study is divided into periods:
Initial Screening: You'll undergo tests and procedures, including a colonoscopy, to determine eligibility.
Treatment: Participants receive either the study treatment or a placebo, but neither you nor your doctor will know which one you are getting. Periodic assessments will be conducted, and you may continue depending on the response.
Open-Label Phase: If your condition worsens and you are eligible, you'll switch to a phase where both you and your doctor know the study drug you're receiving.
Your study doctor will be able to provide more detailed information on what will happen if you decide to participate.
How do I Participate?
1.
Complete the online questions to see if you pre-qualify
2.
Submit your contact information
3.
Answer our phone call to answer more questions to help us determine if you are eligible
4.
Confirm your interest and preferred study site location
5.
Speak with the study site about the next steps to participate
Find out if the SPECIFI-CD Crohn’s study might be a match for you
Please answer a few questions to see if you may qualify for the study.
With your consent, we (Trialbee) will collect and use the information you submit here to indicate your interest in the study, and to see if you are eligible to move to the next stage of screening.
During the next stage, you will be contacted by Trialbee to ask some additional questions to further assess your eligibility and discuss study participation.
Frequently Asked Questions
What will happen after I complete the online questionnaire?
Should your online questionnaire suggest that you are potentially eligible, a qualified medical professional will contact you to conduct a more comprehensive telephone medical assessment and further evaluate your eligibility. Upon confirmation of your potential eligibility during the telephone medical assessment, you will be presented with nearby study sites conducting the clinical study. The study site of your choice will be provided with your contact details in order to schedule an appointment to share more details about the study and learn about your medical history.
Where can I find more information about SPECIFI-CD Crohn’s clinical study?
If you are interested to learn more about the clinical study, we encourage you to complete a few questions to help assess if there is a study that could be a match. You can then be referred to a study site in your area for answering all your questions.
What type of study-related medical care is provided during the study?
Any medical care, tests or procedures that are for the purpose of the study will be provided and will be explained by the study site. There is no insurance required to participate. As you will need to visit the study site throughout the duration of the study, there will be travel reimbursement available.
Why are clinical studies important?
Clinical studies add to medical knowledge and help bring new potential treatments to people with medical conditions. To bring new treatments to the public, they need be assessed in clinical studies, to determine if they work and are safe.
Clinical studies rely on the participation of volunteers. It can take several years for a new potential treatment to reach the public. Often, this timeline is due to how long it takes to complete the clinical study.
All approved prescription drugs have gone through clinical studies to assess their safety and efficacy and to understand what side effects may be involved.
Who runs clinical studies?
Clinical studies can be sponsored, or funded, by pharmaceutical or biotechnology companies, academic medical centers, voluntary groups, or health care providers. The SPECIFI-CD Crohn’s study is funded by Sanofi-Aventis Australia Pty Ltd., a pharmaceutical company.
Every study site is led by a principal investigator, who is a medical doctor. Clinical studies also have a research team that may include doctors, nurses, and other health care professionals. An independent committee of people from outside the study sponsor, called an Ethics Committee, reviews and monitors clinical trials to ensure the rights and welfare of clinical study participants are protected.
What are the phases of clinical studies?
Clinical studies are conducted in different phases.
Phase 1: After researchers have investigated the investigational study drug in laboratory tests to assess its efficacy and ensure that it is safe to test in humans, the Phase 1 study is carried out to test the investigational study drug in a small group of people for the first time. This is done to evaluate its safety, determine a safe dosage range, and identify potential side effects. The investigational study drug is referred to as an investigational study drug since it is under investigation and not yet approved by health authorities for use outside clinical trials.
Phase 2: The investigational study drug is given to a larger group of people (compared to Phase 1) to see if it is effective and to further evaluate its safety.
Phase 3: The investigational study drug is given to large groups of people to confirm its efficacy, monitor side effects, compare it to commonly used treatments or placebo, and collect information that will allow assessment of the investigational study drug’s safety.
The SPECIFI-CD Crohn’s trial is a phase 2 study.
