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

1. Cheng G, et al. Lancet. 2011;377:393–402.