Rituximab as second line treatment for ITP: A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study. “The RITP study” - RITP study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005918-20-FR

Enrollment

110

Registered

2008-10-23

Start date

2008-12-23

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune thrombocytopenic purpura (ITP) MedDRA version: 9.1 Level: LLT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura

Interventions

Trade Name: MabThera Product Name: MabThera Pharmaceutical Form: Concentrate for solution for infusion Other descriptive name: RITUXIMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria (for randomisation): 1. ITP with platelet count 30 x 10e9 /l. d. Other patient related factors necessitating higher platelet count as occupation, hobby, psychological intolerability. e. Age >75 years. 2. Previous treatment with corticosteroids for a minimum duration of 2 weeks as recommended by the protocol (prednisone or prednisolone 1-2 mg/kg/day) with either no response (i.e. failed to achieve an initial increase in Platelet count >30 x 10e9 /l) or relapse (Platelet count falls to or equal = 18 years. 4. Subject has signed and dated written informed consent. 5. Subject is able to understand and comply with protocol requirements and instructions, and intends to complete the study as planned. 6. Females in child-bearing age should accept to use of contraceptive means for at least 6 months following the administration of the study drugs. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Previous splenectomy, chemotherapy, treatment with anti-D Ig, rituximab, or immune-suppressive treatments other than corticosteroids, Dapsone or Danazol. 2. Underlying malignancy or previous history of malignancy in the past 5 years (except skin carcinoma). 3. Pregnancy and lactation. 4. Not willing to participate in the study. 5. Expected survival of or = 4 of the American College of Rheumatology Criteria) (Tan et al, 1982;Hochberg, 1997). 10. Patients currently involved in another clinical trial with evaluation of drug treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective: To assess in both treatment arms the rate of splenectomy at 1.5 years. ;Secondary Objective: Secondary objectives: 1. Response rates. 2. Relapse rate and duration of response. 3. Mortality rate. 4. Complications` rate: bleeding, infection and thromboembolic events. 5. Cost-effectiveness analysis. 6. Consumption of corticosteriods and IVIG in both arms. 7. Immune-reconstruction at 1.5 years. ;Primary end point(s): Primary endpoint: Splenectomy during the follow-up period after randomisation.	—

Measure

Time frame

Main Objective: Primary objective: To assess in both treatment arms the rate of splenectomy at 1.5 years. ;Secondary Objective: Secondary objectives: 1. Response rates. 2. Relapse rate and duration of response. 3. Mortality rate. 4. Complications` rate: bleeding, infection and thromboembolic events. 5. Cost-effectiveness analysis. 6. Consumption of corticosteriods and IVIG in both arms. 7. Immune-reconstruction at 1.5 years. ;Primary end point(s): Primary endpoint: Splenectomy during the follow-up period after randomisation.

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Countries

France, Sweden, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026