Ulcerative Colitis

  • STATUS
    Recruiting
Updated on 8 November 2020

Summary

Ulcerative Colitis

Description

GA28949: Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy (Induction of Remission) And Safety Of Etrolizumab Compared With Adalimumab And Placebo In Patients With Moderate To Severe Ulcerative Colitis Who Are Naïve to TNF Inhibitors.

Details
Condition Ulcerative Colitis
Clinical Study IdentifierTX141632
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

-80 years of age, inclusive
Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
Naive to treatment with any anti-TNF therapy
An inadequate response to or intolerance of prior corticosteroid and/or immunosuppressant treatment
Background regimen for UC may include oral 5-ASA, oral corticosteroids, budenoside MMX, probiotics, AZA, 6-MP, or MTX if doses have been stable during the screening period
Use of highly effective contraception as defined by the protocol

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) as stated in the protocol
Chronic hepatitis B or C infection, HIV or tuberculosis (active or latent)
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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