CompletedPhase 4

Reduce Risk for Crohn's Disease Patients

France192 participantsStarted 2017-02-28

Plain-language summary

The purpose of this study is to compare the effectiveness of weekly subcutaneously administered Methotrexate for maintaining relapse-free sustained steroid/Enteral Nutrition -free 1-year remission compared with: * daily oral Azathioprine / 6 mercaptopurine in low risk paediatric Crohn's disease * subcutaneously administered adalimumab in high risk paediatric Crohn's disease

Who can participate

Age range

6 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Children 6-17, with a new-onset Crohn Disease diagnosed using established criteria (37, 38), requiring a steroid-based or Enteral nutrition based induction therapy
. At initial diagnosis, wPCDAI \>40 or CRP\>2 times upper limit at diagnosis
. all wPCDAI scores (0-120) are possible at inclusion (patients in remission and patients with active disease)
. Luminal active Crohn Disease (B1) with or without B2 and/or B3 disease behavior
. Initial exposure to 5-ASA and derivate is tolerated
. Exposure to antibiotics is tolerated
. If one of the following criteria is present, patients are allocated to the high risk group prior randomization:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of sustained steroid/EEN-free remission at Month 12

Timeframe: Month 12

Trial details

NCT IDNCT02852694

SponsorPIBD-Net

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-14

View on ClinicalTrials.gov More Crohn's Disease trials

Plain-language summary

Who can participate

Age range

6 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Children 6-17, with a new-onset Crohn Disease diagnosed using established criteria (37, 38), requiring a steroid-based or Enteral nutrition based induction therapy
. At initial diagnosis, wPCDAI \>40 or CRP\>2 times upper limit at diagnosis
. all wPCDAI scores (0-120) are possible at inclusion (patients in remission and patients with active disease)
. Luminal active Crohn Disease (B1) with or without B2 and/or B3 disease behavior
. Initial exposure to 5-ASA and derivate is tolerated
. Exposure to antibiotics is tolerated
. If one of the following criteria is present, patients are allocated to the high risk group prior randomization:

Reduce Risk for Crohn's Disease Patients

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Reduce Risk for Crohn's Disease Patients

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria