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A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors

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ClinicalTrials.gov Identifier: NCT02136069
Recruitment Status : Recruiting
First Posted : May 12, 2014
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1 ratio to receive either etrolizumab 105 (milligrams) by subcutaneous (SC) injection [SC] every 4 weeks [Q4W]) + placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then every 8 weeks) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then every 8 weeks) + placebo (SC Q4W). Time on treatment is 54 weeks.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: etrolizumab Drug: infliximab Other: placebo (IV) Other: placebo (injection) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAÏVE TO TNF INHIBITORS
Actual Study Start Date : December 24, 2014
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : March 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: etrolizumab + placebo (IV)
Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV until Week 46
 Drug: etrolizumab
105 mg administered by subcutaneous injection (Q4W) until Week 52

Other: placebo (IV)
Administered by (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.
Active Comparator: infliximab + placebo (injection)
Participants will receive IV Infusion of Iinfliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to ertolizumab SC Q4W until Week 52
 Drug: infliximab
5 mg/kg of infliximab will be administered by intravenous (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.

Other: placebo (injection)
administered by SC injection Q4W until Week 52


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with both Clinical Response at Week 10 and Clinical Remission at Week 54 [ Time Frame: Week 10, Week 54 ]

Secondary Outcome Measures :
  1. Percentage of Participants Achieving Clinical Remission, Defined as MCS </=2 with Individual Subscores </=1 and a Rectal Bleeding Subscore of 0 [ Time Frame: Week 10 ]
  2. Percentage of Participants Achieving Clinical Remission, Defined as MCS </=2 with Individual Subscores </=1 and a Rectal Bleeding Subscore of 0 [ Time Frame: Week 54 ]
  3. Percentage of Participants Achieving Clinical Remission at both Week 10 and Week 54, Defined as MCS </=2 with Individual Subscores </=1 and a Rectal Bleeding Subscore of 0 [ Time Frame: Week 10 and Week 54 ]
  4. Percentage of Participants with Improvement from Baseline in Endoscopic Appearance of the Mucosa at Week 10 [ Time Frame: Baseline to Week 10 ]
  5. Percentage of Participants with Improvement from Baseline in Endoscopic Appearance of the Mucosa at Week 54 [ Time Frame: Baseline to Week 54 ]
  6. Percentage of Participants with Improvement from Baseline in Endoscopic Appearance of the Mucosa at both Week 10 and Week 54 [ Time Frame: Baseline to Week 10, Week 54 ]
  7. Percentage of Participants Achieving Clinical Response, Defined as MCS with >/=3-point Decrease and 30% Reduction from Baseline as well as >/=1-point Decrease in Rectal Bleeding Subscore or an Absolute Rectal Bleeding Score of 0 or 1 [ Time Frame: Week 10 ]
  8. Percentage of Participants with Endoscopic Remission at Week 54 [ Time Frame: Week 54 ]
  9. Percentage of Participants Achieving Clinical Response at both Weeks 10 and 54, Defined as MCS with >/=3-point Decrease and 30% Reduction from Baseline, and >/=1-point Decrease in Rectal Bleeding Subscore or an Absolute Rectal Bleeding Score of 0 or 1 [ Time Frame: Week 10, Week 54 ]
  10. Percentage of Participants that Achieve Clinical Remission Corticosteroid-Free at Week 54 (off Corticosteroid for at Least 24 Weeks Prior to Week 54) [ Time Frame: Week 54 ]
  11. Percentage of participants with Adverse Events [ Time Frame: Baseline up to Week 217 ]
  12. Pharmacokinetic: Etrolizumab Serum Concentration [ Time Frame: Predose (0 hour) at Week 2, 10, 12, 30, 54 ]
  13. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Weeks 10,30 and 54 [ Time Frame: Weeks 10,30 and 54 ]
  14. Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Etrolizumab or Infliximab [ Time Frame: Week 0,4,10,12,30 and 54 ]

Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
  • Naive to treatment with any anti-TNF inhibitor therapy (including TNF inhibitor biosimilars)
  • An inadequate response to or intolerance of prior corticosteroid and/or immunosuppressant treatment
  • Background regimen for UC may include oral 5-aminosalicylate (5-ASA), oral corticosteroids, budenoside 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 during and at least 24 weeks after the last dose of study drug

Exclusion Criteria:

  • A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic, radiation or microscopic 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)
  • History of moderate or severe allergic or anaphylactic/anaphylactoid reactions to chimeric, human, or humanized antibodies; fusion proteins, or murine proteins; hypersensitivity to etrolizumab or any of its excipients
  • Chronic hepatitis B or C infection, Human deficiency virus (HIV) or tuberculosis (active or latent)
Contacts and Locations
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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): NCT02136069


Contacts
Contact: Reference Study ID Number: GA29103 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02136069     History of Changes
Other Study ID Numbers: GA29103
2013-004282-14 ( EudraCT Number )
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018

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