Assessment of Mucosal Activity to Improve the Prognosis of Patients With Crohn's Disease Treated … (NCT01562951) | Clinical Trial Compass
TerminatedPhase 3
Assessment of Mucosal Activity to Improve the Prognosis of Patients With Crohn's Disease Treated With Immunosuppressants
Stopped: Not enough patient population according to selection criteria to complete the study
Belgium15 participantsStarted 2012-10
Plain-language summary
This study will test that individualized treatment in patients with Crohn's Disease in remission or mild clinical activity under immunosuppressants may improve prognosis, rather than just treating flares.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-75 years old- Patients with CD diagnosis confirmed by colonoscopy
* Patients with inflammatory CD of terminal ileal, colonic or ileocolonic location
* Maintenance treatment with at least 2 mg/kg/day for azathioprine/ 1 mg/kg/day for mercaptopurine or the highest dosage tolerated in patients who could not tolerate this dosage, at least 6 months.
* Willingness to sign informed consent
* If female of childbearing age, be post-menopausal, surgically sterile, or willing to use a reliable form of birth control for the duration of the study (such as physical barrier \[patient and partner\], contraceptive pill or patch, spermicide and barrier, or intrauterine device)and for at least five months after the last adalimumab treatment.
* Able to comply with the requirements of the study.
* CDAI score ≤ 220.
* Calprotectin \> or = 250µg/g and/or hsCRP \> or = 5mg/L.
* Significant lesions seen during colonoscopy, as defined by CDEIS.
Exclusion Criteria:
* Patients with an ostomy, or ileoanal pouch (subject with previous ileo-rectal anastomosis are not excluded), draining fistula, abscess
* Patients who had intestinal resection within one year.
* Symptomatic stricture either diagnosed by colonoscopy or clinically suspected and confirmed by imaging techniques.
* Prior treatment with any anti-tumor necrosis factor (TNF) drug.
* Patients receiving rectal treatment 1 month before inclusion
* Signs of active infection
* Previous history of active untreated or inade…
What they're measuring
1
The primary efficacy endpoint is the rate of therapeutic failure up to week 48
Timeframe: Every 12 weeks up to Week 48
Trial details
NCT IDNCT01562951
SponsorGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa