192
Participants
Start Date
April 30, 2007
Primary Completion Date
May 31, 2010
Study Completion Date
May 31, 2010
Adalimumab
All subjects received an open-label adalimumab induction regimen. Subjects weighing greater than or equal to 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing less than 40 kg at Baseline received 80 mg at Week 0 and 40mg at Week 2.
Adalimumab
Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
Adalimumab
Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
Site Reference ID/Investigator# 7744, Brussels
Site Reference ID/Investigator# 6073, Brussels
Site Reference ID/Investigator# 6700, Antwerp
Site Reference ID/Investigator# 4913, New Hyde Park
Site Reference ID/Investigator# 3734, Mineola
Site Reference ID/Investigator# 8801, Buffalo
Site Reference ID/Investigator# 6071, Prague
Site Reference ID/Investigator# 5892, Philadelphia
Site Reference ID/Investigator# 4317, Baltimore
Site Reference ID/Investigator# 6257, Chapel Hill
Site Reference ID/Investigator# 5904, Atlanta
Site Reference ID/Investigator# 4911, Orlando
Site Reference ID/Investigator# 7640, Orlando
Site Reference ID/Investigator# 6354, Nashville
Site Reference ID/Investigator# 4914, Columbus
Site Reference ID/Investigator# 4909, Cincinnati
Site Reference ID/Investigator# 4912, Indianapolis
Site Reference ID/Investigator# 4950, Milwaukee
Site Reference ID/Investigator# 4285, Saint Paul
Site Reference ID/Investigator# 5102, Rochester
Site Reference ID/Investigator# 5901, Maywood
Site Reference ID/Investigator# 4316, Chicago
Site Reference ID/Investigator# 6065, Paris
Site Reference ID/Investigator# 6072, Paris
Site Reference ID/Investigator# 5222, Aurora
Site Reference ID/Investigator# 3826, Las Vegas
Site Reference ID/Investigator# 5223, Orange
Site Reference ID/Investigator# 4984, San Francisco
Site Reference ID/Investigator# 4983, Seattle
Site Reference ID/Investigator# 10287, Los Angeles
Site Reference ID/Investigator# 5676, Hartford
Site Reference ID/Investigator# 6182, Morristown
Site Reference ID/Investigator# 5109, Calgary
Site Reference ID/Investigator# 4916, Halifax
Site Reference ID/Investigator# 10284, Hamilton
Site Reference ID/Investigator# 8391, London
Site Reference ID/Investigator# 5169, Ottawa
Site Reference ID/Investigator# 6798, Toronto
Site Reference ID/Investigator# 5570, Vancouver
Site Reference ID/Investigator# 16501, Amsterdam
Site Reference ID/Investigator# 14750, Nijmegen
Site Reference ID/Investigator# 13622, Rotterdam
Site Reference ID/Investigator# 6428, Warsaw
Site Reference ID/Investigator# 6430, Wroclaw
Site Reference ID/Investigator# 7742, London
Lead Sponsor
Abbott
INDUSTRY