Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease
Condition: Moderate to Severe Crohn's Disease
MeSH terms: Crohn Disease
Intervention: adalimumab
Intervention description: Adalimumab pre-filled syringe, administered by subcutaneous injection
Intervention MeSH terms: Adalimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Crohn's Disease

Summary:

      The purpose of this study is to evaluate the rapidity of onset of clinical response to
      adalimumab therapy in patients with luminal Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Crohn's disease (CD) diagnosed within, at least, the previous 4 months.

          -  Patients with active luminal (Harvey-Bradshaw Index [HBI] ≥ 8) moderate to- severe CD.

          -  No response to a full and adequate course of therapy with a corticosteroid and/or an
             immunosuppressant.

          -  If receiving any of the following treatments, their dose should be stable during the
             periods indicated:

               -  Aminosalicylates for, at least, the last 4 weeks

               -  Probiotics for, at least, the last 4 weeks

               -  Analgesics for, at least, the last 4 weeks

               -  Antidiarrheals for, at least, the last 4 weeks

               -  CD-related antibiotics for, at least, the last 4 weeks

               -  Azathioprine, 6-mercaptopurine or methotrexate for, at least, the last 12 weeks

          -  If receiving any of the following treatments, their dose should not have been increase
             in the past two weeks (the dose reduction is permitted):

               -  Oral budesonide (maximum dose of 9 mg/day)

               -  Oral prednisone or equivalent (maximum dose of 40mg/day)

        Exclusion Criteria:

          -  Previous treatment with any anti-Tumor Necrosis Factor agent

          -  Surgical bowel resection within the previous 6 months, ostomy, extensive bowel
             resection (> 100 cm), short bowel syndrome

          -  Fistulising Crohn's disease

          -  Treatment with cyclosporine or tacrolimus within the previous 8 weeks

          -  Clinically significant cardiac disease including unstable angina, acute myocardial
             infarction within six months from screening, congestive heart failure of worse than
             grade II New York criteria (New York Heart Association Functional Classification).

          -  Subject with an ostomy or ileoanal pouch, proctocolectomy, total colectomy, ileostomy,
             stoma or ileal pouch-anal anastomosis (Subjects with a previous ileo-rectal
             anastomosis are not excluded).

          -  Screening laboratory values (according to central laboratory)

          -  Known hepatitis C (HC) infection.

          -  Serologic evidence of hepatitis B (HB) infection based on the results of testing for
             hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc) and
             hepatitis B surface antibody (anti-HBs) antibodies.