English to Spanish Medical Medical: Pharmaceuticals Informed Consent

Forty-five patients with a CD activity index (CDAI) of 250–450 were randomised in a dose escalating fashion to receive single doses of fontolizumab or placebo. By day 29, patients with clinical response were re-randomised to receive three additional doses of one half their initial fontolizumab dose or placebo at four weekly intervals. Primary objectives were safety and tolerability. Secondary outcomes included assessments of immunogenicity, clinical activity, and potential pharmacodynamic surrogates.