RAISE: A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING ITP PATIENTS’ RESPONSE TO REVOLADE VERSUS PLACEBO1
Objective
The phase III, double-blind, placebo-controlled RAISE study (ClinicalTrials.gov, number NCT00370331) aimed to investigate the response to REVOLADE versus placebo in ITP patients during a 6-month period.
Inclusion criteria
- Age: ≥18 years
- Diagnosis: chronic ITP (defined as >6 months' duration with baseline platelet counts <30,000/µL)
- Previous treatment: patients had responded to 1 or more previous ITP treatments
- Splenectomy status: splenectomised or non-splenectomised
Number of patients
-
197 patients randomised (2:1)
- REVOLADE + local standard of care: n=135
- Placebo + local standard of care: n=62
REVOLADE treatment regimen
- REVOLADE starting dose: 50 mg once daily
- Dose modifications were made on the basis of individual platelet response (increases to a maximum of 75 mg/day and dose decreases to 25 mg/day)
- Treatment duration: 6 months
Primary endpoint
- The odds of response to REVOLADE (defined as platelet count of 50,000–400,000/µL) versus placebo over 6 months of treatment
Secondary endpoints
- Median platelet count
- Proportion of patients responding at ≥75% of assessments
- Mean cumulative weeks of response
- Mean maximum weeks of continuous response
- Bleeding symptoms
- Reduction of baseline treatment for ITP
- Use of rescue medicine
Abbreviation: ITP, immune thrombocytopenia.
Reference
- Cheng G, et al. Lancet. 2011;377:393–402.
HCP19-C002f(1) June 2020.