A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
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.
Idiopathic Thrombocytopenic Purpura
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Percentage of Participants With a Sustained Response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]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.
- Percentage of Participants With an Initial Response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2005|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Dexamethasone
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.
Experimental: Dexamethasone plus Rituximab
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.
Other Name: MabThera/RituxanDrug: Dexamethasone
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770562
|Bari, Italy, 70124|
|Bologna, Italy, 40138|
|Brescia, Italy, 25123|
|Cagliari, Italy, 09121|
|Cuneo, Italy, 12100|
|Genova, Italy, 16132|
|Milano, Italy, 20162|
|Napoli, Italy, 80131|
|Padova, Italy, 35128|
|Palermo, Italy, 90146|
|Pavia, Italy, 27100|
|Pesaro, Italy, 61100|
|Pescara, Italy, 65100|
|Ravenna, Italy, 48100|
|Reggio Emilia, Italy, 42100|
|Roma, Italy, 00133|
|Roma, Italy, 00161|
|Roma, Italy, 00168|
|Siena, Italy, 53100|
|Taranto, Italy, 74100|
|Udine, Italy, 33100|
|Verona, Italy, 37130|
|Study Chair:||Clinical Trials||Hoffmann-La Roche|