Clinical Trials Directory

Trials / Completed

CompletedNCT01173120

Methotrexate - Inadequate Response Device Sub-Study

Sub-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
62 (actual)
Sponsor
Bristol-Myers Squibb · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine the safety and acceptability of a device used in place of traditional syringes for abatacept self-injection.

Conditions

Interventions

TypeNameDescription
DEVICEAbatacept combination product (ACP)Abatacept Solution, Subcutaneous, 125 mg/device, Weekly, 3 months

Timeline

Start date
2009-11-01
Primary completion
2010-02-01
Completion
2010-07-01
First posted
2010-07-30
Last updated
2012-01-12
Results posted
2011-07-06

Source: ClinicalTrials.gov record NCT01173120. Inclusion in this directory is not an endorsement.