Clinical Trial Results:
A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the
Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in
Subjects with Active Ulcerative Colitis (UC) who have had an Inadequate Clinical
Response and/or Intolerance to Medical Therapy.
Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-06). + Protocol amendment 04 (Biopsy substudy) - Site specific
Summary
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EudraCT number |
2006-003604-19 |
Trial protocol |
DE FR IE BE GB CZ PL IT |
Global completion date |
19 Aug 2009
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Dec 2016
|
First version publication date |
24 Dec 2016
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Other versions |
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Summary report(s) |
IM101-108_Synopsis |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.