Evaluation of Low Dose Infliximab in Ankylosing Spondylitis (Study P04352)

PHASE3CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

May 1, 2005

Primary Completion Date

May 1, 2007

Study Completion Date

May 1, 2007

Conditions
Spondylitis, Ankylosing
Interventions
BIOLOGICAL

infliximab

Infliximab 3 mg/kg infusions at Weeks 0, 2, and 6 and every 8 weeks thereafter. Subjects who lose response according to a pre-specified criteria at weeks 22 or 38 visit will increase the dose of infliximab to 5 mg/kg (rounded up to the nearest vial).

BIOLOGICAL

Placebo

Placebo infusions at Weeks 0, 2, and 6. Subjects will be evaluated at Week 12 after which they will receive infliximab 3 mg/kg at Weeks 16, 18, and 22 then every 8 weeks. Subjects who lose response according to a pre-specified criteria at weeks 22 or 38 visit will increase the dose of infliximab to 5 mg/kg (rounded up to the nearest vial).

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00202865 - Evaluation of Low Dose Infliximab in Ankylosing Spondylitis (Study P04352) | Biotech Hunter | Biotech Hunter