MedTrace Logo

Study to Evaluate SC Route of Administration of Ofatumumab in RA Patients

NCT00686868 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-06-26

No results posted yet for this study

Summary

This study will examine the safety and tolerability, PK and PD of subcutaneously administered GSK1841157 in patients with RA on stable dose Methotrexate. The study comprises a single dose escalation/de-escalation phase to investigate the minimal efficacious dose based on PD markers with an acceptable safety profile.

Conditions

  • Arthritis, Rheumatoid

Interventions

OTHER

placebo

placebo

DRUG

ofatumumab

fully human anti-CD20 monoclonal antibody

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-13
Primary Completion
2011-03-11
Completion
2011-05-02

Countries

  • United States
  • Australia
  • Belgium
  • France
  • Italy
  • New Zealand
  • Poland
  • Russia
  • Spain

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 NCT00686868 on ClinicalTrials.gov