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Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403

NCT00655824 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2017-12-05

Study results available
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Summary

A 3-year open-label trial for patients who previously participated in Trial Hx-CD20-403 and who fulfill the eligibility criteria for this trial (GEN413) . Th e primary purpose of the trial is to evaluate the long-term effectiveness of repeated courses ( a maximum of 9 treatment courses) of ofatumumab in RA patients who previously received ofatumumab or placebo in Trial Hx-CD20-403.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

ofatumumab

1000 mL dilution of 35mls ofatumumab in sterile, pyrogen free, 0.9% NaCl

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-01
Primary Completion
2011-05-25
Completion
2013-03-19

Countries

  • United States
  • Denmark
  • Hungary
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00655824 on ClinicalTrials.gov