Back to resultsA Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
Primary Purpose
Idiopathic Thrombocytopenic Purpura
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
rituximab
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Thrombocytopenic Purpura
Eligibility Criteria
Inclusion Criteria:
- adult patients >=18 years of age;
- untreated ITP.
Exclusion Criteria:
- ITP with relapse;
- positive test result for HIV or hepatitis B or C;
- active infection requiring systemic therapy;
- malignancy within 3 years before study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Dexamethasone
Dexamethasone plus Rituximab
Arm Description
Participants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), intravenously (IV), with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets less than (<) 20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with immunoglobulin (IgG) IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
Outcomes
Primary Outcome Measures
Percentage of Participants With a Sustained Response
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.
Secondary Outcome Measures
Percentage of Participants With an Initial Response
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00770562
Brief Title
A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
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 Thrombocytopenic Purpura
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Thrombocytopenic Purpura
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Participants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), intravenously (IV), with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
Arm Title
Dexamethasone plus Rituximab
Arm Type
Experimental
Arm Description
Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets less than (<) 20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with immunoglobulin (IgG) IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
Intervention Type
Drug
Intervention Name(s)
rituximab
Other Intervention Name(s)
MabThera/Rituxan
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Primary Outcome Measure Information:
Title
Percentage of Participants With a Sustained Response
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants With an Initial Response
Description
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.
Time Frame
Week 4
Title
Percentage of Participants With an Initial Complete Response
Description
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.
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients >=18 years of age;
untreated ITP.
Exclusion Criteria:
ITP with relapse;
positive test result for HIV or hepatitis B or C;
active infection requiring systemic therapy;
malignancy within 3 years before study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Bari
ZIP/Postal Code
70124
Country
Italy
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Brescia
ZIP/Postal Code
25123
Country
Italy
City
Cagliari
ZIP/Postal Code
09121
Country
Italy
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
City
Genova
ZIP/Postal Code
16132
Country
Italy
City
Milano
ZIP/Postal Code
20162
Country
Italy
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Palermo
ZIP/Postal Code
90146
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Pesaro
ZIP/Postal Code
61100
Country
Italy
City
Pescara
ZIP/Postal Code
65100
Country
Italy
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
City
Roma
ZIP/Postal Code
00133
Country
Italy
City
Roma
ZIP/Postal Code
00161
Country
Italy
City
Roma
ZIP/Postal Code
00168
Country
Italy
City
Siena
ZIP/Postal Code
53100
Country
Italy
City
Taranto
ZIP/Postal Code
74100
Country
Italy
City
Udine
ZIP/Postal Code
33100
Country
Italy
City
Verona
ZIP/Postal Code
37130
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
20130241
Citation
Zaja F, Baccarani M, Mazza P, Bocchia M, Gugliotta L, Zaccaria A, Vianelli N, Defina M, Tieghi A, Amadori S, Campagna S, Ferrara F, Angelucci E, Usala E, Cantoni S, Visani G, Fornaro A, Rizzi R, De Stefano V, Casulli F, Battista ML, Isola M, Soldano F, Gamba E, Fanin R. Dexamethasone plus rituximab yields higher sustained response rates than dexamethasone monotherapy in adults with primary immune thrombocytopenia. Blood. 2010 Apr 8;115(14):2755-62. doi: 10.1182/blood-2009-07-229815. Epub 2010 Feb 3.
Results Reference
derived
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A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
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