Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease (RAPIDA)

AbbVie

Status and phase: Completed; Phase 4

Conditions: Moderate to Severe Crohn's Disease

Treatments: Biological: adalimumab

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02148718

W13-984

2013-004781-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Adalimumab

Experimental group

Description:

Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).

Treatment:

Biological: adalimumab