Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007199

Trial Description

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Title

AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This two-part, open-label extension (OLE) and safety monitoring (SM) study will examine the
efficacy and safety of continued etrolizumab treatment in moderate t

o severe ulcerative colitis (UC) patients previously enrolled in etrolizumab Pha se III
studies.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007199
  •   2014/11/27
  •   2014/04/16
  •   no
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Secondary IDs

  •   NCT02118584  (ClinicalTrials.gov)
  •   GA28951  (Hoffmann-La Roche)
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Health Condition or Problem studied

  •   Ulcerative Colitis
  •   K51 -  Ulcerative colitis
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Interventions/Observational Groups

  •   Drug: etrolizumab
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   III
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Primary Outcome

- Long-term efficacy as determined by partial Mayo Clinic Score (pMCS); time frame: Up to 7 years
- Incidence of adverse events; time frame: Up to 7 years

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Secondary Outcome

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Austria
  •   Belgium
  •   Brazil
  •   Bulgaria
  •   Canada
  •   Colombia
  •   Croatia
  •   Czech Republic
  •   Denmark
  •   Estonia
  •   France
  •   Germany
  •   Greece
  •   Hong Kong
  •   Hungary
  •   Israel
  •   Italy
  •   Korea, Republic of
  •   Latvia
  •   Lithuania
  •   Malaysia
  •   Mexico
  •   Netherlands
  •   New Zealand
  •   Norway
  •   Philippines
  •   Poland
  •   Portugal
  •   Romania
  •   Russian Federation
  •   Serbia
  •   Singapore
  •   Slovakia
  •   South Africa
  •   Spain
  •   Sweden
  •   Switzerland
  •   Turkey
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2014/08/31
  •   2600
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Part 1 (Open-label Extension)

- Patients previously enrolled in Phase III controlled studies who meet the eligibility
criteria for open-label etrolizumab for those studies as described in the protocol

Part 2 (Safety Monitoring)

- Patients who participated in one of the etrolizumab Phase III studies and are not
eligible or chose not to enter Part 1 (OLE)

- Patients who transfer from Part 1 (OLE)

- Completion of the 12-week safety follow-up prior to entering.

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Exclusion Criteria

Part 1 (Open-label Extension)

- Any new, significant, uncontrolled condition

Part 2 (Safety Monitoring)

- No exclusion criteria

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Addresses

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    • Hoffmann-La Roche
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    • Hoffmann-La Roche
    • Clinical Trials 
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    • Reference Study ID Number: GA28951 www.roche.com/about_roche/roche_worldwide.htm 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.