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A Study of the Safety and Efficacy of Etrolizumab in Patients With Moderately to Severely Active Crohn's Disease

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02394028
First received: February 27, 2015
Last updated: March 9, 2017
Last verified: March 2017
  Purpose
This is a multicenter, Phase III, double-blind, placebo-controlled study evaluating the safety and efficacy of etrolizumab during induction and maintenance treatment of moderate to severely active Crohn's disease (CD) in patients who are anti-tumor necrosis factor (TNF) naive (TNF-naive) and in patients who are refractory or intolerant of tumor necrosis factor inhibitors.

Condition Intervention Phase
Crohn Disease Drug: Etrolizumab 210 mg Drug: Etrolizumab 105 mg Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Maintenance of clinical remission (as determined by PRO2 score) at Week 66 (US) [ Time Frame: At Week 66 ]
  • Induction Phase: Clinical remission as determined by the Crohn's Disease Activity Index (CDAI) score (ex-US) [ Time Frame: At Week 14 ]
  • Maintenance of clinical remission (as determined by CDAI score) after at least 52 weeks and corticosteroid-free for at least 52 weeks (ex-US) [ Time Frame: 52 weeks ]
  • Induction Phase: Clinical remission as determined by the 2 Item Patient Reported Outcome (PRO2) score (US) [ Time Frame: At Week 14 ]

Secondary Outcome Measures:
  • Safety (composite outcome measure): Incidence and severity of adverse events; incidence of anti-therapeutic antibodies to etrolizumab [ Time Frame: Up to 90 weeks ]
  • Proportion of patients who achieve 100 points reduction in their CDAI score (CDAI-100 response) [ Time Frame: At Week 14 ]
  • Maintenance Phase: Proportion of patients who achieve CDAI-100 response [ Time Frame: At Week 66 ]

Estimated Enrollment: 1250
Actual Study Start Date: March 31, 2015
Estimated Study Completion Date: July 31, 2019
Estimated Primary Completion Date: July 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etrolizumab 105 mg Q4W in Induction and Maintenance Arms Drug: Etrolizumab 105 mg
Induction Phase : 105 mg dose subcutaneous administration at Weeks 0,4,8 and 12; Maintenance Phase : Single 105 mg dose subcutaneous administration Q4W
Experimental: Etrolizumab 210 mg Weeks 0,2,4,8 and 12 in Induction Arm only Drug: Etrolizumab 210 mg
Induction phase only: 210 mg dose subcutaneous injection administration at Weeks 0,2,4,8 and 12
Placebo Comparator: Placebo Drug: Placebo
Matching placebo to either etrolizumab 105 mg or etrolizumab 210 mg according to the treatment schedule

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-80 years of age (inclusive)
  • Moderately to severely active Crohn's disease as determined by the Crohn's Disease Activity Index (CDAI), patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon
  • Intolerance, loss of response or failure to respond to corticosteroids (CS) or, immunosuppressants (IS), or TNF inhibitors within the previous 5 years
  • Use of effective contraception as defined by the protocol

Exclusion Criteria:

  • A history of, or current conditions affecting the digestive tract, such as ulcerative colitis, indeterminant colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome
  • Planned surgery for CD
  • Ileostomy or colostomy
  • Has received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efilizumab, as stated in the protocol)
  • Chronic hepatitis B or C infection, HIV, active or latent tuberculosis (patients with prior history of BCG vaccination must pass protocol-defined screening criteria)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02394028

Contacts
Contact: Reference Study ID Number: GA29144 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

  Show 440 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02394028     History of Changes
Other Study ID Numbers: GA29144
2014-003824-36 ( EudraCT Number )
Study First Received: February 27, 2015
Last Updated: March 9, 2017

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 21, 2017