Study Comparing the usefulness and safety of Etrolizumab Vs Placebo in patients with Ulcerative Colitis.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/04/008363
• Date of registration: 18-04-2017
• Prospective Registration: Yes
• Primary sponsor: F HoffmannLa Roche Ltd
• Public title: Study Comparing the usefulness and safety of Etrolizumab Vs Placebo in patients with Ulcerative Colitis.
• Scientific 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 Naive To TNF Inhibitors.
• Date of first enrolment: 15-05-2017
• Target sample size: 350
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18359
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Centralized Blinding and masking:Double Blind Double Dummy
• Phase: Phase 3

Countries of recruitment

Argentina, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, France, Germany, India, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Ukraine, United Kingdom, United States of America

Contacts

• Name: Priyanka Bhattacharya
• Affiliation: Roche Products (India) Pvt. Ltd.

• Name: Priyanka Bhattacharya
• Affiliation: Roche Products (India) Pvt. Ltd.

Key inclusion & exclusion criteria

Inclusion criteria: Able and willing to provide written informed consent

Diagnosis of UC established at least 6 months prior

Moderately to severely active UC as determined by an MCS

Evidence of UC extending a minimum of 20 cm from the anal verge

Naive to treatment with any anti-TNF therapy
Exclusion criteria: Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC

Past or present ileostomy or colostomy

Diagnosis of indeterminate colitis

Any prior treatment with etrolizumab or other anti-integrin agents

Pregnant or lactating

Infection Risk

Abnormal Laboratory Values



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Patients with moderate to severe active Ulcerative Colitis who wre naive to TNF Inhibitors Health Condition 2: K519- Ulcerative colitis, unspecified

Intervention(s)

Intervention1: ETROLIZUMAB: IMP, 105 mg given as 0.7 mL of a 150-mg/mL solution will be administered by SC injection Q4W.
Control Intervention1: Placebo: NIL

Primary Outcome(s)

Remission at Week 62 among randomized patients in remission at Week 10Timepoint: Remission at Week 62 among randomized patients in remission at Week 10

Secondary Outcome(s)

Clinical remission at Week 62 among randomized patients in clinical remission at

Week 10

Clinical remission at Week 62

Clinical response at Week 62

Improvement in endoscopic appearance of the mucosa at Week 62

Endoscopic remission at Week 62Timepoint: Specified above

Secondary ID(s)

GA29102, Version 5, 28-Aug-2015

Source(s) of Monetary Support

F HoffmannLa Roche Ltd. Grenzacherstrasse 124 CH-4070 Basel, Switzerland

Secondary Sponsor(s)

Roche Products India Pvt Ltd

Ethics review

Status: Approved
Approval date: 02/01/2017
Contact:

POONA MEDICAL RESEARCH FOUNDATION, IEC

Status: Approved
Approval date: 12/01/2017
Contact:

Manipal University Ethics Committee

Status: Approved
Approval date: 14/02/2017
Contact:

NIRMAL HOSPITAL IEC

Status: Approved
Approval date: 17/05/2019
Contact:

S. R. KALLA MEMORIAL HOSPITAL ETHICS COMMITTEE

Status: Not Approved
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Ethics Committee, Dispur Hospital Pvt Ltd

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Ethics Committee, KLE University, JNMC Campus

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Ethics Committee, Osmania medical College,

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Institutional Ethics Committee , Seth GS Medical College and KEM Hospital,

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Institutional Ethics Committee Rahate Surgical Hospital

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Institutional Ethics Committee, Midas Multispeciality Hospital Pvt.Ltd,

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Institutional Ethics Committee, Deccan College and Medical Science, Owaisi Hospital & Research Center

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Institutional Ethics Committee, P.D. Hinduja National Hospital & Medical Research Centre,

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Institutional Ethics Committee, Poona Medical Research Foundation,

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Institutional Ethics Committee, Sparsh Hospital

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Institutional Ethics committee,Maulana Azad Medical college

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Kaizen Ethics Committee, Kaizen Hospital,

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Pushpawati Singhania Research Institute Ethics Committee

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Seth Nandlal Dhoot Hospital institutional Ethics committee

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Shree Giriraj Hospital Research Ethics Committee, Ground Floor