Phase 2
N=122
A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.
Idiopathic Thrombocytopenic Purpura
Bottom Line
View on ClinicalTrials.gov: NCT00475423 ↗Enrolled (actual)
122
Serious AEs
9.8%
Results posted
Feb 2015
Primary outcome: Primary: Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR) — 43.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rituximab [MabThera/Rituxan] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR) |
43.5 | — |
| SECONDARY Percentage of Participants With Hematological CR, PR, or Minor Response (MR) |
9.3; 34.3; 17.6 | — |
| SECONDARY Percentage of Participants Who Achieved CR |
27.8 | — |
| SECONDARY Time to CR |
NA | — |
| SECONDARY Percentage of Participants Who Achieved PR |
56.5 | — |
| SECONDARY Time to PR |
53.0 | — |
| SECONDARY Percentage of Participants Who Achieved MR |
71.3 | — |
| SECONDARY Time to MR |
22.0 | — |
| SECONDARY Percentage of Participants With Continued CR From Week 8 to Week 52 |
10 | — |
| SECONDARY Duration of CR in Participants With Continued CR From Week 8 Until Week 52 |
NA | — |
| SECONDARY Duration of PR in Participants With Continued PR From Week 8 Until Week 52 |
247.0 | — |
| SECONDARY Duration of MR in Participants With Continued MR From Week 8 Until Week 52 |
256.0 | — |
| SECONDARY Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event |
50.0 | — |
| SECONDARY Time to Initiation of New ITP Therapy |
314.0 | — |
| SECONDARY Percentage of Therapeutic Responders |
43.5; 35.2 | — |
| SECONDARY Percentage of Participants With a Therapeutic Response |
38.0; 5.6; 0.0; 56.5; 35.2; 0.0 | — |
| SECONDARY Cluster of Differentiation 19 (CD19) B Cell Count |
0.27; 0.30; 0.01; 0.01; 0.01; 0.03 | — |
| SECONDARY Change From Baseline in CD19 B Cell Count |
-0.23; -0.27; -0.21; -0.23; -0.22; -0.08 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00475423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.