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A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.

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ClinicalTrials.gov Identifier: NCT00475423
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE May 17, 2007
First Posted Date  ICMJE May 21, 2007
Results First Submitted Date  ICMJE October 6, 2014
Results First Posted Date  ICMJE February 23, 2015
Last Update Posted Date February 23, 2015
Study Start Date  ICMJE May 2007
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2015)
Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR) [ Time Frame: Week 8 ]
Percentage of participants with an overall response at Week 8 achieving a CR or PR as evaluated by platelets, new or increased Idiopathic Thrombocytopenic Purpura (ITP)-related treatments and corticosteroids given for Adverse Events (AEs). CR was defined as a platelet count of greater than (>) 150x10^9/ liters (L) over at least 2 consecutive measurements at least 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. PR was defined as platelet count of >50x10^9/L over at least 2 consecutive measurements at least <2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Overall response rate (participants who achieved CR or confirmed PR) was evaluated using platelets, new or increased ITP related treatments, and corticosteroids given for AEs.
Original Primary Outcome Measures  ICMJE
 (submitted: May 17, 2007)
Overall response rate at week 8.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2015)
  • Percentage of Participants With Hematological CR, PR, or Minor Response (MR) [ Time Frame: Week 8 ]
    Percentage of participants with CR, PR, and MR at Week 8 as evaluated by platelet count where CR is greater than or equal to (≥)150x10^9/L, PR ≥ 50x10^9/L, MR equals (=) 30x10^9/L over 2 consecutive measurements at least 2 weeks apart but no more than 60 days apart with no increase in concomitant therapy or initiation of new ITP therapy.
  • Percentage of Participants Who Achieved CR [ Time Frame: Week 52 ]
    CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
  • Time to CR [ Time Frame: Baseline to Week 52 ]
    Time to CR was defined as the time from the first infusion to the first date on which CR was achieved. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants without an event were censored at the date of last assessment.
  • Percentage of Participants Who Achieved PR [ Time Frame: Week 52 ]
    PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
  • Time to PR [ Time Frame: Baseline to Week 52 ]
    Time to response was defined as the time from the first infusion to the first date on which PR was achieved. PR was defined as platelet counts > 50x10^9/L over ≥ 2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
  • Percentage of Participants Who Achieved MR [ Time Frame: Week 52 ]
    MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
  • Time to MR [ Time Frame: Baseline to Week 52 ]
    Time to response was defined as the time from the first infusion to the first date on which MR was achieved. MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 percent (%) to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
  • Percentage of Participants With Continued CR From Week 8 to Week 52 [ Time Frame: Week 8 to Week 52 ]
    The number of participants with a durable CR assessed in CR responders whose responses were sustained from Week 8 through to the end of the study or withdrawal, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
  • Duration of CR in Participants With Continued CR From Week 8 Until Week 52 [ Time Frame: Week 8 to Week 52 ]
    Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of CR, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
  • Duration of PR in Participants With Continued PR From Week 8 Until Week 52 [ Time Frame: Week 8 to Week 52 ]
    Duration of PR was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of PR, irrespective of change of treatment. PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
  • Duration of MR in Participants With Continued MR From Week 8 Until Week 52 [ Time Frame: Week 8 to Week 52 ]
    Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of MR, irrespective of change of treatment. MR was defined as participants registered with ITP in relapse with a platelet count of > 30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50% to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
  • Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event [ Time Frame: Week 52 ]
    Percentage of participants with an event of initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.
  • Time to Initiation of New ITP Therapy [ Time Frame: Baseline to Week 52 ]
    Median time in days to initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.
  • Percentage of Therapeutic Responders [ Time Frame: Week 26 and Week 52 ]
    Percentage of participants with a therapeutic response, defined as achieving CR, PR, or MR assessed at Week 26 and Week 52 or hematological response, defined as achieving CR, PR, or MR at Week 8. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR response was defined as at least a minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least a minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.
  • Percentage of Participants With a Therapeutic Response [ Time Frame: Week 26 and Week 52 ]
    Number of therapeutic responder participants by CR, PR, MR, or no response (NR) measured at Week 26 and Week 52. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR was defined as at least minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.
  • Cluster of Differentiation 19 (CD19) B Cell Count [ Time Frame: Baseline, Weeks 1, 3, and 8, Follow-up Months 4, 6, 8, 10, and 12, and Last Day ]
    Value of mean CD19+ B cell count at baseline. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L.
  • Change From Baseline in CD19 B Cell Count [ Time Frame: Weeks 3, 8 and Months 4, 6, 8, 10 and 12, and last day ]
    Actual values of CD19+ mean B cell count assessed at Weeks 3 and 8, and Months 4, 6, 8, 10 and 12, and last day. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2007)
Efficacy: Time to complete and partial response; complete and partial response rates; duration of response; time to new therapy. Safety: AEs, hematological toxicity, infections, infusion reactions.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.
Official Title  ICMJE An Open Label Study of a Fixed Dose Regimen of MabThera on Overall Response Rate in Patients With Refractory, Relapsing or Chronic Idiopathic Thrombocytopenic Purpura.
Brief Summary This single arm study will evaluate the efficacy and safety of MabThera monotherapy in patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura (ITP). Patients will receive infusions of MabThera 1000mg i.v. on days 1 and 15. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Thrombocytopenic Purpura
Intervention  ICMJE Drug: rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15
Study Arms  ICMJE Experimental: 1
Intervention: Drug: rituximab [MabThera/Rituxan]
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2015)
122
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • refractory, relapsing or chronic idiopathic thrombocytopenic purpura;
  • stable therapy during 3 weeks prior to study entry.

Exclusion Criteria:

  • newly diagnosed ITP (<6 weeks);
  • prior treatment with MabThera;
  • active bleeding requiring platelet transfusion within 7 days prior to entry into study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00475423
Other Study ID Numbers  ICMJE ML20948
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP