Assessment of Mucosal Activity to Improve the Prognosis of Patients With Crohn's Disease Treated With Immunosuppressants

• Status: Terminated
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
• Collaborators: Abbott; TFS Trial Form Support
• Treatments: Adalimumab; Immunosuppressive Agents

Criteria

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 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:

• Live vaccines.

• 5-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.

• Oral corticosteroids (eg., Prednisone, budesonide) should be discontinued for 3 months before study inclusion.

• Antibiotics for CD. Only antibiotics used to treat a concurrent infection are allowed.

• Immunomodulators:

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

• Monoclonal antibodies or anti-TNF drugs.

• Aspirin or Non-steroidal anti-inflammatory drugs (NSAIDs). Treatment with aspirin and/or NSAIDS should not occur for more than 15 consecutive days before collecting of the stool sample for Calprotectin and performing the colonoscopy.

• Screening laboratory and other analyses show any of the following abnormal results:

• Aspartate transaminase (AST) or alanine transaminase (ALT) > 2 x the upper limit of the reference range;

• Total bilirubin ≥ 3 mg/dL (51 μmol/L);

• Serum creatinine > 1.6 mg/dL (144 μmol/L)

• History of any drug or alcohol abuse in the past 2 years

• Receipt of other study product within 3 months of inclusion in this study

• Patients employed by the sponsor or in any relationship of dependence with the sponsor and/or investigator

• Staff at the study center

• Hypersensitivity to the active substance or to any of the excipients