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

NCT02148718 | Completed Phase 4 Results

• 2 other identifiers: W13-9842013-004781-34
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Keywords

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Clinical Response at Day 4

  Clinical response defined as a decrease of at least 3 points in Harvey-Bradshaw Index (HBI) score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.

  Day 4

Secondary Outcomes (17)

• Percentage of Participants With Clinical Response at Week 1

  Week 1

• Percentage of Participants With Clinical Remission at Weeks 2 and 4

  Weeks 2 and 4

• European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Index Score: Change From Baseline to Week 12

  Baseline (Week 0) and Week 12

• European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Visual Analog Scale (VAS): Change From Baseline to Week 12

  Baseline (Week 0) and Week 12

• Inflammatory Bowel Disease Quality-36 (IBDQ-36) Questionnaire Overall Score: Change From Baseline to Week 12

  Baseline (Week 0) and Week 12

Study Arms (1)

Adalimumab

EXPERIMENTAL

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).

Biological: adalimumab

Interventions

adalimumab BIOLOGICAL

Adalimumab pre-filled syringe, administered by subcutaneous injection

Also known as: Humira, ABT-D2E7

Adalimumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead
• Laboratorio Echevarne: collaborator
• Pivotal S.L.: collaborator

Related Links

• Related info.

MeSH Terms

Conditions

Crohn Disease

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Ignacio Marín, PhD

  Hospital General Universitario Gregorio Marañon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: May 28, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: January 1, 2017
• Last Updated: March 1, 2018
• Results First Posted: August 29, 2017

Record last verified: 2018-02