Clinical Trial: A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Open-label Study of First-line Treatment With Dexamethasone or Dexamethasone Plus MabThera on Sustained Treatment Response in Adult Patients With Idiopathic Thrombo

Brief Summary: This study will compare the efficacy, safety, and pharmacokinetics of standard treatment versus standard treatment plus MabThera in patients with ITP. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Detailed Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome: Percentage of Participants With a Sustained Response [ Time Frame: Week 24 ]

Sustained response defined as a platelet count of greater than or equal to (≥) 50x10^9/L at 6 months (Week 24) after the initial treatment. Participants failing therapy before Month 6 (Week 24) and treated in other ways were considered failures.


Original Primary Outcome: Sustained response 6 months after initial treatment

Current Secondary Outcome:

  • Percentage of Participants With an Initial Response [ Time Frame: Week 4 ]
    Initial response was defined as an increase in platelet count of ≥50x10^9/L by Day 30 (Week 4) after the start of treatment in either treatment arm.
  • Percentage of Participants With an Initial Complete Response [ Time Frame: Week 4 ]
    Initial complete response was defined as an increase in platelet count of ≥100x10^9/L by Day 30 (Week 4) after the initiation of treatment in either treatment arm.


Original Secondary Outcome: Initial response by day 30 after initiation of treatment; incidence of serious and life-threatening adverse events

Information By: Hoffmann-La Roche

Dates:
Date Received: October 9, 2008
Date Started: July 2005
Date Completion:
Last Updated: October 21, 2014
Last Verified: October 2014