We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors

This study is currently recruiting participants.
Verified March 2017 by Hoffmann-La Roche
Sponsor:
ClinicalTrials.gov Identifier:
NCT02165215
First Posted: June 17, 2014
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This Phase III, randomized, double blind, parallel grouped, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in participants with moderately to severely active ulcerative colitis (UC) who are naïve to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.

Condition Intervention Phase
Colitis, Ulcerative Drug: Etrolizumab Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared With Placebo in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naïve to TNF Inhibitors

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants in Remission at Week 62 Among Randomized Participants in Remission at Week 10 as Determined by the Mayo Clinic Score (MCS) [ Time Frame: Week 62 ]

Secondary Outcome Measures:
  • Percentage of Participants who Maintained Clinical Remission at Week 62 Among Randomized Participants in Clinical Remission at Week 10 as Determined by the MCS [ Time Frame: Week 62 ]
  • Percentage of Participants in Clinical Remission at Week 62 as Determined by the MCS [ Time Frame: Week 62 ]
  • Percentage of Participants With Clinical Response at Week 62 as Determined by the MCS [ Time Frame: Week 62 ]
  • Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Week 62 [ Time Frame: Week 62 ]
  • Percentage of Participants With Endoscopic Remission at Week 62 [ Time Frame: Week 62 ]
  • Percentage of Participants With Corticosteroid-free Clinical Remission at Week 62 Among Participants Who Were Receiving Corticosteroids at Baseline [ Time Frame: Baseline, Week 62 ]
  • Percentage of Participants With Corticosteroid-free Remission at Week 62 Among Participants Who Were Receiving Corticosteroids at Baseline [ Time Frame: Baseline, Week 62 ]
  • Percentage of Participants With Histologic Remission at Week 62 [ Time Frame: Week 62 ]
  • Change from Baseline to Week 62 in UC Bowel Movement Signs and Symptoms as Assessed by the UC-Patient Reported Outcome Signs and Safety (UC-PRO/SS) Measure [ Time Frame: Baseline, Week 62 ]
  • Change From Baseline to Week 62 in UC Abdominal Symptoms as Assessed by the UC-PRO/SS Measure [ Time Frame: Baseline, Week 62 ]
  • Change From Baseline to Week 62 in Health-related Quality of Life (HQOL) as Assessed by the Overall Score of the Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline, Week 62 ]
  • Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 74 ]
  • Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Etrolizumab [ Time Frame: Baseline up to Week 62 (assessed at Weeks 4, 12, 24, 44, 62) ]
  • Serum Trough Concentration of Etrolizumab During Dosing Period from Week 12 to Week 62 [ Time Frame: Prior to administration of etrolizumab injection (0 hour) at Weeks 12, 24, 44, 62 ]
  • Serum Concentration of Etrolizumab at Week 62 [ Time Frame: Prior to administration of etrolizumab injection (0 hour) at Week 62 ]

Estimated Enrollment: 350
Actual Study Start Date: August 31, 2014
Estimated Study Completion Date: March 31, 2019
Estimated Primary Completion Date: March 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etrolizumab (Maintenance Phase)
Participants who achieved a clinical response at Week 10 during induction phase and randomized to this arm will receive etrolizumab 105 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) up to Week 62.
Drug: Etrolizumab
Participants will receive 105 mg etrolizumab SC injection Q4W.
Experimental: Etrolizumab (Open-label Induction Phase)
All participants will receive treatment with open-label etrolizumab 105 mg SC injection for every Q4W up to Week 10.
Drug: Etrolizumab
Participants will receive 105 mg etrolizumab SC injection Q4W.
Placebo Comparator: Placebo (Maintenance Phase)
Participants who achieved a clinical response at Week 10 during induction phase and are randomized to this arm will receive placebo matched to etrolizumab up to Week 62.
Drug: Placebo
Participants will receive etrolizumab matching placebo Q4W.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Moderately to severely active UC as determined by the MCS assessment
  • Evidence of UC extending a minimum of 20 centimeters (cm) from the anal verge as determined by baseline endoscopy (flexible sigmoidoscopy or colonoscopy) performed between 4 and 10 days prior to Day 1
  • Naive to treatment with any anti-TNF therapy
  • Participants must have had an inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment
  • Background regimen for UC may include oral 5-aminosalicylate (5-ASA), oral corticosteroids, budesonide multi-matrix system (MMX), probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
  • Use of highly effective contraception
  • Must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening

Exclusion Criteria:

  • A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
  • Prior or planned surgery for UC
  • Past or present ileostomy or colostomy
  • Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab) as stated in the protocol
  • Chronic hepatitis B or C infection, human immunodeficiency virus (HIV) or tuberculosis (active or latent)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165215


Contacts
Contact: Reference Study ID Number: GA29102 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

  Show 219 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: NCT02165215     History of Changes
Other Study ID Numbers: GA29102
2013-004280-31 ( EudraCT Number )
First Submitted: June 13, 2014
First Posted: June 17, 2014
Last Update Posted: March 10, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases