Remicade Safety Line (Crohn's Disease)(Study P03288)(COMPLETED)

CompletedOBSERVATIONAL
Enrollment

148

Participants

Timeline

Start Date

December 31, 2002

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2010

Conditions
Crohn's Disease
Interventions
BIOLOGICAL

Remicade (infliximab)

Participants with confirmed diagnosis of severe active Crohn's disease (CD) and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of infliximab therapy with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Centocor, Inc.

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY