Clinical Trial Results:
The OPERA Study.
Optimized treatment algorithm in early rheumatoid arthritis:
Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis.
A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development.
Summary
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EudraCT number |
2007-000082-38 |
Trial protocol |
DK |
Global completion date |
30 Dec 2011
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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 |
13 Oct 2021
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First version publication date |
13 Oct 2021
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Other versions |
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Summary report(s) |
The OPERA Study - Hørslev-Petersen K, el al Ann Rheum Dis 2014;73:654-661 |
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.