Arthritis, Rheumatoid Clinical Trial
Official title:
A Double-blind, Randomized, Placebo Controlled, Parallel Group, Multi-center, Phase III Trial of Ofatumumab Investigating Clinical Efficacy in Patients With Active Rheumatoid Arthritis Who Have Previously Had an Inadequate Response to One or More TNF Antagonist Therapies
This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a duration of 24 weeks, followed by a 120 week Open-label Period. The primary purpose of the study is to demonstrate the efficacy and safety of ofatumumab in reducing clinical signs and symptoms in adult RA patients who had an inadequate response to TNF-α antagonist therapy.
This study consist of a double-blind, placebo controlled, and parallel group part with
eligible patients enrolled into a 24 week Double-Blind Period, and randomized in a 1:1 ratio
to receive either ofatumumab or placebo in addition to their background methotrexate
treatment. Patients who complete the 24 week Double-blind Period without receiving rescue
DMARD treatment will then be eligible to proceed into the 120 week Open-label Period to
receive repeat treatment courses with ofatumumab. In the Open-label Period ofatumumab
treatment courses will be given at individualized time intervals only if a clinical response
has been achieved following the previous treatment course, and followed by a subsequent
worsening in disease activity.
Patients who have completed the Open-label Period or have been withdrawn will then enter a
maximum 2 year Follow-up Period, or until there B-cells return to normal or to baseline
levels, whichever occurs earlier
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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