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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 April 2022 |
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Main ID: |
EUCTR2005-005918-20-FR |
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Date of registration:
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23/10/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Rituximab as second line treatment for ITP:
A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study.
“The RITP study”
- RITP study
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Scientific title:
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Rituximab as second line treatment for ITP:
A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study.
“The RITP study”
- RITP study |
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Date of first enrolment:
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23/12/2008 |
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Target sample size:
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110 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005918-20 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Sweden
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Inclusion criteria (for randomisation):
1. ITP with platelet count <30 x 10e9 /l or 30-50 x 10e9 /l if a higher platelet count is considered necessary because of any of the following:
a. Concomitant medical illness predisposing to bleeding (gastric ulcer, bleeding diathesis, previous history of bleeding).
b. Concomitant medical condition requiring aspirin and/or clopidogrel intake or anticoagulation.
c. Persistent bleeding manifestations despite platelets > 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 < 30 x 10e9 /l) during the dose tapering period or after discontinuation of corticosteroids.
3. Subject is > 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:
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 < 2 years.
6. Known intolerance to murine antibodies.
7. Females in child-bearing age not willing to use contraception for 6 months.
8. HIV/AIDS-, Hepatitis -B virus antigen positive- or Hepatitis -C virus antibodies positive- patients.
9. Patients with Systemic Lupus Erythematosus (SLE) (> 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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Immune thrombocytopenic purpura (ITP)
MedDRA version: 9.1
Level: LLT
Classification code 10021245
Term: Idiopathic thrombocytopenic purpura
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Intervention(s)
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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 type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Main Objective: Primary objective: To assess in both treatment arms the rate of splenectomy at 1.5 years.
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Primary end point(s): Primary endpoint: Splenectomy during the follow-up period after randomisation.
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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.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 23/12/2008
Contact:
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