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Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy

NCT01698307 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1095

Last updated 2021-11-11

No results posted yet for this study

Summary

Assess if the implementation of an enhanced treatment algorithm will improve the management Crohn's Disease compared to a conventional Step-care approach.

Conditions

Interventions

OTHER

Enhanced Treatment Algorithm

The Enhanced algorithm features the early use of combined antimetabolite/adalimumab therapy, and treatment intensification based on ileocolonoscopic findings. Failure to achieve or sustain Deep Remission, which includes sustained normalization of the imaging studies, will result in treatment intensification, according to the steps outlined in the algorithm, irrespective of symptoms.

OTHER

Conventional Step-care Algorithm

Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Score.

Sponsors & Collaborators

  • Alimentiv Inc.

    lead OTHER

Principal Investigators

  • Brian G Feagan, MD · Robarts Clinical Trials - Western University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-28
Primary Completion
2020-04-16
Completion
2020-04-16

Countries

  • United States
  • Canada
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01698307 on ClinicalTrials.gov