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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 (GARDENIA)

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ClinicalTrials.gov Identifier: NCT02136069
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : December 8, 2020
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 (mg) by subcutaneous (SC) injection once every 4 weeks (Q4W) + placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then once every 8 weeks [Q8W]) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then Q8W) + 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)
Actual Enrollment : 397 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 Naive to TNF Inhibitors
Actual Study Start Date : December 24, 2014
Actual Primary Completion Date : June 23, 2020
Actual Study Completion Date : June 23, 2020

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 infusion until Week 46.
 Drug: Etrolizumab
105 mg administered by subcutaneous (SC) injection once every 4 weeks (Q4W) until Week 52.
Other Names:
  • PRO145223
  • RO5490261
  • RG7413

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 infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection 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 at Week 10, Defined as Mayo Clinic Score (MCS) ≤2 with Individual Subscores ≤1 [ Time Frame: Week 10 ]
  2. Percentage of Participants Achieving Clinical Remission at Week 54 [ Time Frame: Week 54 ]
  3. Percentage of Participants Achieving Clinical Remission at Both Week 10 and Week 54 [ Time Frame: Week 10 and Week 54 ]
  4. Percentage of Participants Achieving Clinical Remission at Week 54 Among Those with a Clinical Response at Week 10 [ Time Frame: Week 10 and Week 54 ]
  5. Percentage of Participants with Improvement from Baseline in Endoscopic Appearance of the Mucosa at Week 10 [ Time Frame: Baseline to Week 10 ]
  6. Percentage of Participants with Improvement from Baseline in Endoscopic Appearance of the Mucosa at Week 54 [ Time Frame: Baseline to Week 54 ]
  7. 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 ]
  8. Percentage of Participants with Endoscopic Remission at Week 54 [ Time Frame: Week 54 ]
  9. Percentage of Participants Achieving Clinical Response at Week 10, 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 ]
  10. Percentage of Participants Achieving Clinical Response at Both Weeks 10 and 54 [ Time Frame: Week 10, Week 54 ]
  11. Percentage of Participants that Achieve Clinical Remission Corticosteroid-Free at Week 54 (off Corticosteroid for at Least 24 Weeks Prior to Week 54) Among Those Who Were Receiving Corticosteroids at Baseline [ Time Frame: Baseline and Week 54 ]
  12. Number of Participants with Adverse Events, Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) [ Time Frame: Baseline up to Week 54 ]
  13. Number of Participants with Adverse Events Leading to Study Drug Discontinuation [ Time Frame: Baseline up to Week 54 ]
  14. Number of Participants with Infection-Related Adverse Events, Severity Determined According to the NCI CTCAE v4.0 [ Time Frame: Baseline up to Week 54 ]
  15. Number of Participants with Serious Infection-Related Adverse Events [ Time Frame: Baseline up to Week 54 ]
  16. Number of Participants with Malignancies [ Time Frame: Baseline up to Week 54 ]
  17. Number of Participants with Injection-Site Reactions, Severity Determined According to the NCI CTCAE v4.0 [ Time Frame: Baseline up to Week 54 ]
  18. Number of Participants with Hypersensitivity Reaction Events, Severity Determined According to the NCI CTCAE v4.0 [ Time Frame: Baseline up to Week 54 ]
  19. Pharmacokinetics: Etrolizumab Serum Concentration [ Time Frame: Predose (0 hour) at Weeks 2, 10, 12, 30, and 54 ]
  20. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Overall Score at Weeks 10, 30, and 54 [ Time Frame: Weeks 10, 30, and 54 ]
  21. Number of Participants with Anti-Therapeutic Antibodies (ATAs) to Etrolizumab or Infliximab [ Time Frame: Weeks 0, 4, 10, 12, 30, and 54 ]

Eligibility Criteria
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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, efalizumab, and tofactinib)
  • 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


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02136069    
Other Study ID Numbers: GA29103
2013-004282-14 ( EudraCT Number )
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
 Inflammatory Bowel Diseases
Infliximab
rhuMAb Beta7
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs