T80 "Long Term Safety Follow Up Study"

Item relates to the Centocor and Kennedy Institute safety follow up study protocol C0168T80, "a multicentre international observational study of the long-term safety of infliximab." The study began in 1997 with the aim to conduct a long-term follow-up safety review of patients who had previously participated in cA2 clinical studies. Centocor collected data on 90% of patients who participated in cA2 trials at six months, one, two and three years from their last infusion. This includes KIR 2000, T14, T18, T07 and T09 trials.

The item contains draft questionnaires, Riverside Research Ethics Committee correspondence and application, correspondence, Serious Adverse Event reports and data clarification forms.

See SA/KET/A/2 for further Centocor research collaboration papers.

1997-2004

1 file (in 3 parts)

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