Clinical Trial Results:
A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX)
Summary
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EudraCT number |
2011-005021-48 |
Trial protocol |
CZ HU ES PL BG NL |
Global completion date |
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Nov 2021
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First version publication date |
18 Nov 2021
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Other versions |
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Summary report(s) |
TL011-RA-301 Withdrawn Study Statement.pdf |
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.