A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
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
1 other identifier
interventional
103
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2005
Typical duration for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 9, 2008
CompletedFirst Posted
Study publicly available on registry
October 10, 2008
CompletedResults Posted
Study results publicly available
October 22, 2014
CompletedOctober 22, 2014
October 1, 2014
3 years
October 9, 2008
June 26, 2014
October 21, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Week 24
Secondary Outcomes (2)
Percentage of Participants With an Initial Response
Week 4
Percentage of Participants With an Initial Complete Response
Week 4
Study Arms (2)
Dexamethasone
ACTIVE COMPARATORParticipants 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.
Dexamethasone plus Rituximab
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- adult patients \>=18 years of age;
- untreated ITP.
You may not qualify if:
- ITP with relapse;
- positive test result for HIV or hepatitis B or C;
- active infection requiring systemic therapy;
- malignancy within 3 years before study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Unknown Facility
Bari, 70124, Italy
Unknown Facility
Bologna, 40138, Italy
Unknown Facility
Brescia, 25123, Italy
Unknown Facility
Cagliari, 09121, Italy
Unknown Facility
Cuneo, 12100, Italy
Unknown Facility
Genova, 16132, Italy
Unknown Facility
Milan, 20162, Italy
Unknown Facility
Napoli, 80131, Italy
Unknown Facility
Padua, 35128, Italy
Unknown Facility
Palermo, 90146, Italy
Unknown Facility
Pavia, 27100, Italy
Unknown Facility
Pesaro, 61100, Italy
Unknown Facility
Pescara, 65100, Italy
Unknown Facility
Ravenna, 48100, Italy
Unknown Facility
Reggio Emilia, 42100, Italy
Unknown Facility
Roma, 00133, Italy
Unknown Facility
Roma, 00161, Italy
Unknown Facility
Roma, 00168, Italy
Unknown Facility
Siena, 53100, Italy
Unknown Facility
Taranto, 74100, Italy
Unknown Facility
Udine, 33100, Italy
Unknown Facility
Verona, 37130, Italy
Related Publications (1)
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.
PMID: 20130241DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2008
First Posted
October 10, 2008
Study Start
July 1, 2005
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
October 22, 2014
Results First Posted
October 22, 2014
Record last verified: 2014-10