NCT00559585

Methotrexate-Inadequate Response Study

A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,492 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DRUG	Subcutaneous (SC) Abatacept	Participants received 125 mg weekly SC abatacept injections (with an intravenous \[IV\] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.
DRUG	Intravenous (IV) Abatacept	Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). 500mg (for body weight up to 60 kg) 750 mg (body weight between 61 and 100 kg) 1g (body weight above 100 kg)infusions

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-11-01
• Completion: 2014-09-01
• First posted: 2007-11-16
• Last updated: 2015-11-09
• Results posted: 2011-07-06

Locations

203 sites across 24 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, France, Germany, Greece, Hungary, India, Ireland, Italy, Mexico, Netherlands, Peru, Poland, Russia, South Africa, South Korea, Taiwan, Turkey (Türkiye), United Kingdom