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

Sponsor: AbbVie
Study ID: NCT02148718
Phase: PHASE4
Status: Completed

Conditions

Moderate to Severe Crohn's Disease

Eligibility Criteria

Sex: ALL
Age: 18 Years - 75 Years
Healthy Volunteers: Not accepted

Interventions

adalimumab — BIOLOGICAL
Adalimumab pre-filled syringe, administered by subcutaneous injection

Study Details

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.

Key Dates

Start date: Jun 30, 2014
Status verified: Feb 2018
Primary completion: Aug 31, 2016
Completion: Jan 31, 2017

Study Design

Enrollment: 100 participants (actual)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: 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).

Primary Outcome Measure

Percentage of Participants With Clinical Response at Day 4 [ Time Frame: Day 4 ]