Remicade: how long were the pivotal tox studies?

“A 6 months toxicity study with an anti-mouse TNFα monoclonal antibody (chimeric V1q muG2a, which has functional characteristics similar to infliximab) was submitted in year 2001.”

“In this study, CD-1 mice were given 25 weekly i.v. doses of 10 or 40 mg/kg cV1q. No cV1q treatment-related mortality or clinical signs of toxicity were observed.”

“In this study, CD-1 mice were given 25 weekly i.v. doses of 10 or 40 mg/kg cV1q.”