EVALUATING THE SAFETY AND EFFICICACY OF INFLIXIMAB (REMICADE)

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a Phase 2, 52wk, multicenter, randomized, double-blind, placebo-controlled clinical study to compare the safety and efficacy of 2 treatment regimens (3mg/kg or 5mg/kg) of infliximab with placebo in the treatment of subjects with chronic acidosis with pulmonary involvement who are symptomatic despite current treatment, with a goal of improving lung function. Extrapulmonary involvement will be investigated in a exploratory manner. Two subsets of subjects identified as special interests are subjects with skin involvement at baseline and subjects with eye involvement at baseline. Infliximab (3mg/kg or 5mg/kg) or placebo will be infused at weeks 0, 2, 6, 12, 18 and 24. Approximately 120 subjects will be enrolled in approximately 25 investigational centers located in North America and Europe. The primary end point of this study is the change from baseline in the percent of predicted FVC at wk 24. At wk 24, all subjects will be assessed for the primary and secondary endpoints. Subjects will continue to be followed to wk 52 for assessment of safety and the durability of any clinical effects after discontinuation of therapy. Two database locks are planned (1 after wk-24 data are cleaned and finalized and 1 after wk-52 data are cleaned and finalized).