Crohn's disease (CD) is an inflammatory disease of the intestines that primarily causes abdominal pain, diarrhea, vomiting, or weight loss.
Conditions
Sponsors
Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Visit 0 (Pre Screening Visit) To be eligible for the Screening period, patients must satisfy all of the following criteria at Visit 0 (Pre Screening Visit): -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). -Able to comply with the requirements of the study. Visit 1 (Screening Visit 1) To be eligible to continue in the study, patients must satisfy the following criterion at Visit 1 (Screening Visit 1): -CDAI score ? 220. -Calprotectin > 250µg/g and/or hsCRP > 5mg/L. Visit 2 (Screening Visit 2) To be eligible to continue in the study, patients must satisfy the following criterion at Visit 2 (Screening Visit 2): -Significant lesions seen during colonoscopy, as defined by CDEIS. Significance is defined as CDEIS > 3 or any deep ulcer or superficial ulcers covering more than 10% of at least one segment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: Visit 0 (Pre Screening Visit) Patients will be excluded from the study if one or more of the following statements are applicable at Visit 0 (Pre Screening Visit): ?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- TNF drug. ?Treatments with corticosteroids 3 months before inclusion (including budesonide). ?Patients receiving rectal treatment 1 month before inclusion. ?Changes of azathioprine/mercaptopurine dosage in the last 12 weeks. ?Treatment with aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs) for at least 15 non-consecutive days in the month before inclusion. ?Signs of active infection. ?Previous history of active untreated or inadequately treated tuberculosis (TB) or latent TB. Patients should be screened for latent TB as per local guidelines or clinical practice in the country of study conduct. Patients with latent TB should be treated with standard antimycobacterial therapy (for at least 4 weeks) before initiating biologic therapy and have a negative CRX for active TB at screening. ?Subjects with a poorly controlled medical condition such as: uncontrolled diabetes with documented history of recurrent infections, unstable ischemic heart disease, moderate to severe congestive heart failure (New York Heart Association [NYHA] class III or IV), recent cerebrovascular accident, or any other condition which, in the opinion of the Investigator or the sponsor, would put the subject at risk by participation in the protocol. ?Signs of colon cancer or dysplasia. ?Signs of severe or unstable renal, hepatic, gastrointestinal, cardiovascular, respiratory, neurological, psychiatric, or hematological disease. ?Signs of cancer in the past five years, except for localized and treated basal cell skin cancer or cervical cancer. ?Patients who are pregnant or nursing. ?Concomitant treatment with: oLive vaccines. o5-ASA compounds: ?Rectal 5-ASA should be discontinued at least 4 weeks before study inclusion. ?Oral 5-ASA must be at a stable dose for at least 4 weeks before study inclusion. If oral 5-ASA has recently been discontinued, 4 weeks should pass before study inclusion. oOral corticosteroids (eg. Prednisone, budesonide) should be discontinued for 3 months before study inclusion. oAntibiotics for CD. Only antibiotics used to treat a concurrent infection are allowed. oImmunomodulators: ?Patients receiving therapy with azathioprine/mercaptopurine must have been on a stable dose for at least 12 weeks before inclusion and must continue with the same dose during the study. ?No treatment with other known immunomodulators (eg. methotrexate, 6-thioguanine [6-TG], cyclosporine, tacrolimus, sirolimus, ustekinumab, pentoxifylline, or mycophenolate mofetil) or experimental drugs (eg., factor colony stimulating granulocyte macrophage [GM-CSF]) within 6 months. oMonoclonal antibodies or anti-TNF drugs. oAspirin or Non-steroidal anti-inflammatory drugs (NSAIDs). In addition, treatment with aspirin and/or NSAIDS should not occur for more than 15 days before inclusion. ?Screening laboratory and other analyses show any of the following abnormal results: oAspartate transaminase (AST) or alanine transaminase (ALT) > 2 x the upper limit of the reference range;
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints (not all of which will be determined in a preliminary analysis) are: ?The rate of therapeutic failure up to week 24. ?Change in CDEIS from baseline to week 48. ?The rate of mucosal healing (CDEIS=0) at week 48. ?The rate of CDEIS remission (CDEIS<=3) at week 48. ?The rate of CDEIS response, which is defined as a decrease of at least 4 points in CDEIS from baseline to week 48. ?Change in CDAI from baseline to week 12, 24, 36 and 48. ?Change in the global score based on IBDQ from baseline to week 12, 24, 36, and 48. ?Change in the scores based on WPAI from baseline to week 12, 24, 36 and 48. ?Area Under the Curve (AUC) over 48 weeks for CDAI. ?The number of surgical interventions related to CD up to 24 and 48 weeks. ?The rate of hospital admissions related to the disease, to the treatment side effects or other causes up to weeks 24 or 48. ?Calprotectin levels based on PhiCal tests; ?hsCRP;Timepoint(s) of evaluation of this end point: Data will be evaluated in combination after last patient last visit. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the effect of individualized treatment according to a new calprotectin and hsCRP-based diagnostic-therapeutic strategy on the mid-term outcome CD patients.;Secondary Objective: The secondary objectives are: ?To assess the effect of an individualized treatment according to a new calprotectin and hsCRP-based diagnostic-therapeutic strategy on mucosal healing, quality of life, work productivity, number of hospital admissions and surgical interventions; ?To determine the value of calprotectin hsCRP in predicting clinical relapse and mucosal healing; To correlate hsCRP with calprotectin .;Primary end point(s): The primary efficacy endpoint is the rate of therapeutic failure up to week 48.;Timepoint(s) of evaluation of this end point: Data will be evaluated in combination after last patient last visit. | — |
Countries
Spain
Contacts
Public ContactPresident GETECCU
Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)
Outcome results
None listed