• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Genentech completes phase III enrollment for Actemra study

Genentech completes phase III enrollment for Actemra study

October 14, 2015
CenterWatch Staff

Genentech has announced the completion of enrollment for a phase III clinical trial investigating the use of Actemra (tocilizumab) in patients with giant cell arteritis (GCA). The data from the trial (NCT01791153) is expected in 2016.

The aim of the study is to determine the efficacy and safety of Actemra for the treatment of GCA, a condition that affects about one in 5000 individuals over the age of 50 and is the most common form of primary vasculitis (arteritis). There currently is no FDA approved treatment for GCA and the only treatments known to be effective for this disease are steroids.

“GCA treatment usually involves high doses of corticosteroids, which are nearly invariably associated with significant side effects,” said John Stone, M.D., MPH, The Edward Fox Chair of Medicine at Massachusetts General Hospital and professor of medicine at Harvard Medical School. “This trial will certainly add valuable data to the clinical body of evidence surrounding GCA.”

The multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of Actemra (tocilizumab) in patients with giant cell arteritis. Patients will be randomized to receive Actemra 162mg subcutaneously weekly or every two weeks or placebo for 52 weeks, with tapering oral daily doses of prednisone according to either a six month or 12 month regime. After week 52, patients in remission will stop study treatment and enter long-term follow-up, whereas patients with disease activity or flares will receive open-label Actemra 162mg subcutaneously weekly for a maximum period of 104 weeks at the discretion of the investigator. Anticipated time on study is 39 months.

Upcoming Events

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing