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New treatment option for Crohn Disease
Official title Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Patients
ClinicalTrials.gov ID: NCT06953791
What this study is testing
What is Prednisolone?
Prednisolone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for crohn disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Crohn's disease (CD), a type of inflammatory bowel disease (IBD), is on the rise globally. Although medical treatments have advanced, CD still leads to significant health issues due to disease progression and medication side effects.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must be ≥ 18 years at the time of signing the informed consent.
- Macroscopic small bowel involvement, or isolated large bowel disease confined to the right or transverse colon confirmed by endoscopy
- Patients with a Crohn's disease activity index (CDAI) of ≥ 150
- Patients will not be excluded if they have received 5ASA or an immunomodulator for \> 8 weeks and the dose is stable, or if they start a thiopurine...
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures
You likely can't join if
- Patients with with minimal disease activity (CDAI \ 450)
- Patients who have received corticosteroids of any kind in the previous 4 weeks
- Patients who have started an immunomodulator in the previous 8 weeks
- Any current biological or small molecule treatment
- Isolated large bowel disease iinvolving the recto-sigmoid or descending colon
- Patients with penetrating disease (abscess or fistula)
See the full eligibility criteria
- Must be ≥ 18 years at the time of signing the informed consent.
- Macroscopic small bowel involvement, or isolated large bowel disease confined to the right or transverse colon confirmed by endoscopy
- Patients with a Crohn's disease activity index (CDAI) of ≥ 150
- Patients will not be excluded if they have received 5ASA or an immunomodulator for \> 8 weeks and the dose is stable, or if they start a thiopurine concurrently, as thiopurines are not considered sufficient to induce...
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures
- Able to adhere to the study visit schedule and other protocol requirements
- All people must agree to refrain from donating blood while on study drugs
- All people must agree not to share medication.
- Subject (male or female) is willing to use highly effective contraceptive methods during treatment and for 28 days (male or female) after the end of treatment
- Patients with with minimal disease activity (CDAI \ 450)
- Patients who have received corticosteroids of any kind in the previous 4 weeks
- Patients who have started an immunomodulator in the previous 8 weeks
- Any current biological or small molecule treatment
- Isolated large bowel disease iinvolving the recto-sigmoid or descending colon
- Patients with penetrating disease (abscess or fistula)
- Active perianal disease
- Fixed stricture or small bowel obstruction
- Normal fecal calprotectin
- Active extraintestinal disease (e.g. joint disease)
- Patients who have undergone an intestinal resection
- Sclerosing cholangitis
- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
- Women during pregnancy and lactation Participation in other clinical trials or observation period of competing trials.
The study team makes the final eligibility decision.
Where it's taking place
- Tübingen, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tübingen, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.