MedTrace Logo

Efficacy and Safety of Two Treatment Algorithms in Adults With Moderate to Severe Crohn's Disease

NCT01235689 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2018-01-16

Study results available
· View outcomes & findings →

Summary

The primary objective of this study was to demonstrate that tight control of disease activity, using stringent criteria based on Crohn's disease activity Index (CDAI), biomarkers (high sensitivity C-reactive protein \[hs-CRP\] and fecal calprotectin), and corticosteroid use, improves the rate of mucosal healing 48 weeks after randomization compared with management using less stringent criteria based only on CDAI and corticosteroid use.

Conditions

Interventions

BIOLOGICAL

Adalimumab

If adalimumab was initiated, it was administered subcutaneously as a 160 mg induction dose the first week, followed by 80 mg 2 weeks later, followed by 40 mg every other week as a maintenance dose. The dose of adalimumab was increased from 40 mg eow to 40 mg every week in participants with an inadequate response and de-escalated to 40 mg eow in participants who met success criteria.

DRUG

Prednisone

The suggested regimen for participants initiating prednisone consisted of a maximum dose of prednisone 40 mg/day for 2 weeks, followed by a fixed taper for 6 weeks.

DRUG

Azathioprine

Participants with normal thiopurine methyltransferase (TPMT) enzyme activity could receive oral azathioprine 2.5 mg/kg/day. In participants with intermediate TPMT enzyme activity azathioprine was initiated at a dose of 1.25 mg/kg/day. The dose of azathioprine was adjusted according to abnormalities of white blood cell (WBC) count, platelet count, liver function tests (LFTs; i.e. alanine transaminase \[ALT\], aspartate transaminase \[AST\], alkaline phosphatase), lipase, blood urea nitrogen (BUN), and serum creatinine.

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Anne Robinson, Pharm.D. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-11
Primary Completion
2016-11-03
Completion
2017-01-03

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01235689 on ClinicalTrials.gov