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Summary of TB cases across indications and trial periods

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1 Summary of TB cases across indications and trial periods
Summary of TB cases across indications and trial periods. †A total of 42 TB cases were reported in rheumatoid arthritis (RA) trials initiated or completed prior to protocol amendment; 20 cases in original RA trials (completed prior to protocol amendment) and 22 in intermediate RA trials (initiated before but completed after the introduction of more stringent PPD screening criteria in 2007). *Of the 22 TB cases in patients with RA from intermediate RA trials (RAPID1 and RAPID2), 9 cases were reported after protocol amendment. Summary of TB cases across indications and trial periods. †A total of 42 TB cases were reported in rheumatoid arthritis (RA) trials initiated or completed prior to protocol amendment; 20 cases in original RA trials (completed prior to protocol amendment) and 22 in intermediate RA trials (initiated before but completed after the introduction of more stringent PPD screening criteria in 2007). *Of the 22 TB cases in patients with RA from intermediate RA trials (RAPID1 and RAPID2), 9 cases were reported after protocol amendment. AxSpA, axial spondyloarthritis; PsA, psoriatic arthritis; IR, incidence rates; PY, patient-years; TB, tuberculosis. X Mariette et al. RMD Open 2015;1:e000044 Copyright © BMJ Publishing Group & EULAR. All rights reserved.


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