Clinical Trial: A Study to Evaluate the Safety and Effect of CFZ533 on Patients With Graves' Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open Label Study to Evaluate the Safety and Efficacy of 12 Week Treatment With CFZ533 in Patients With Graves' Disease

Brief Summary: An open label study to evaluate the safety and efficacy of CFZ533 following 12 weeks treatment in patients with Graves' disease

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome:

  • Percentage of patients whose thyroid stimulating hormone (TSH) levels normalize [ Time Frame: 12 weeks ]
    Normalization of TSH is defined as TSH level greater than 0.35 mU/L
  • Percentage of patients whose total triiodothyronine (total T3) levels decrease [ Time Frame: Baseline, 12 weeks ]
    Reduction in total T3 (change from baseline after 12 weeks of treatment)
  • Percentage of patients whose free thyroxine (free T4) levels decrease [ Time Frame: Baseline, 12 weeks ]
    Reduction in free T4 (change from baseline after 12 weeks of treatment)


Original Primary Outcome: Percentage of patients whose thyroid stimulating hormone (TSH) levels normalize [ Time Frame: 12 weeks ]

Normalization of TSH is defined as TSH level greater than 0.35 mU/L


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Novartis

Dates:
Date Received: March 15, 2016
Date Started: April 19, 2016
Date Completion: May 2, 2017
Last Updated: April 12, 2017
Last Verified: April 2017