BridgeMD
CoCroS trial
EU CTIS ID: 2024-516002-33-01
What this study is testing
The aim of this study is to compare the long-term efficacy and safety of periodic adalimumab as initial treatment in newly diagnosed Crohn's disease (CD) patients compared to standard step-up care with corticosteroids/budesonide as the initial treatment.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Newly diagnosed CD patients or CD patients with a flare, visiting the outpatient clinic or endoscopy ward of the participating centres
- CD diagnosis according to ECCO-guidelines + complete ileocolonoscopy (last endoscopy performed <12 months before screening) + complete small bowel imaging at diagnosis (MRI or CT-enterography)
- Naïve to biologicals
- 18 years old ≤ 70 years old
- Sufficient knowledge of Dutch language
- Smartphone with internet access
You likely can't join if
- Use of prednisone for longer than 4 weeks in the year before screening
- Use of thiopurines in the 3 years before screening
- Indication for primary treatment with biologicals or surgery
- Patients with short bowel syndrome or an ostomy
- Malignancy in the 5 years before screening. Exception is adequately treated nonmelanoma skin cancer
- Contra-indication for TNF-blockers or immunosuppressive agents (Contraindications are: a symptomatic stricture, an abscess, a history of tuberculosis or other granulomatous infection, a positive chest radiograph or Quantiferon or tuberculin skin test with purified protein derivative, a recent history of an opportunistic infection (within the previous 6 months), active infection with hepatitis B or C, infection with the human immunodeficiency virus, multiple sclerosis or cancer (except adequately treated non melanoma skin cancer))
See the full eligibility criteria
- Newly diagnosed CD patients or CD patients with a flare, visiting the outpatient clinic or endoscopy ward of the participating centres
- CD diagnosis according to ECCO-guidelines + complete ileocolonoscopy (last endoscopy performed <12 months before screening) + complete small bowel imaging at diagnosis (MRI or CT-enterography)
- Naïve to biologicals
- 18 years old ≤ 70 years old
- Sufficient knowledge of Dutch language
- Smartphone with internet access
- Use of myIBDcoach or willingness to start using myIBDcoach
- Use of prednisone for longer than 4 weeks in the year before screening
- Use of thiopurines in the 3 years before screening
- Indication for primary treatment with biologicals or surgery
- Patients with short bowel syndrome or an ostomy
- Malignancy in the 5 years before screening. Exception is adequately treated nonmelanoma skin cancer
- Contra-indication for TNF-blockers or immunosuppressive agents (Contraindications are: a symptomatic stricture, an abscess, a history of tuberculosis or other granulomatous infection, a positive chest radiograph or Quantiferon or tuberculin skin test with purified protein derivative, a recent history of an opportunistic infection (within the previous 6 months), active infection with hepatitis B or C, infection with the human immunodeficiency virus, multiple sclerosis or cancer (except adequately treated non melanoma skin cancer))
- Contra-indication for MRI- and CT-enterography
- Use of budesonide (≥6 mg daily) for a duration longer than 3 months in the year before screening
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.