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

NCT ID: NCT02148718

Last Updated: 2018-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-01-31

Brief 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.

Conditions

Moderate to Severe Crohn's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adalimumab

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).

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

Adalimumab pre-filled syringe, administered by subcutaneous injection

Interventions

adalimumab

Adalimumab pre-filled syringe, administered by subcutaneous injection

Intervention Type: BIOLOGICAL

Other Intervention Names

Humira, ABT-D2E7

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratorio Echevarne

INDUSTRY

Sponsor Role: collaborator

Pivotal S.L.

INDUSTRY

Sponsor Role: collaborator

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ignacio Marín, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario Gregorio Marañon

Related Links

http://rxabbvie.com

Related info.

Other Identifiers

2013-004781-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

W13-984

Identifier Type: -

Identifier Source: org_study_id