Rituximab as second line treatment for ITP: A Multicentre, Randomized, Double blind,Placebo-controlled, Phase III study. The RITP study” - The RITP study” Protocol version 5
- Conditions
- Immune thrombocytopenic purpura (ITP).
- Registration Number
- EUCTR2005-005918-20-GB
- Lead Sponsor
- Rikshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 110
1. ITP with platelet count <30 x 109 /l or 30-50 x 109 /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 109 /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 109 /l) or relapse (Platelet count falls to < 30 x 109 /l) during the dose tapering period or after discontinuation of corticosteroids.
3. Subject is >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?
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)
F.1.3.1 Number of subjects for this age range
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) (> 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.
11. Bacterial infections, viral infections, fungal infections, myco-bacterial
infections (excluding ungeal fungal infections) or other evolutive infections or
any other infections episode requiring hospitalisation or treatment with an antibiotics 4 weeks before selection for IV route or within 2 weeks before selection for oral route.
12. History of soft tissue, bone or joint infections (fascitis, abscess, osteomyelitis, septic arthritis) during the last year prior to inclusion in the study.
13. Medical history of relapsing or chronic severe infectious diseases or any other
underlying pathology predisposing to serious infections.
14. Known Primary or secondary immune deficiency syndromes.
15. Administration of a living vaccine within 4 weeks preceding the inclusion in
the study.
16. History of soft tissue, bone or joint infections (fascitis, abscess, osteomyelitis, septic arthritis) during the last year prior to inclusion in the study.
17. Previous treatment with inhibitors of leucocytes transmigration (e.g.:
Tysabri®).
18. Known intolerance to human monoclonal antibodies.
19. Known severe chronic pulmonary obstructive Disease (FEV < 50% or functional dyspnoea grade 3).
20. Known congestive heart failure NYHA (New York Heart Association classification of heart failure) class III and IV.
21. Recent episode (<6 months) of acute coronary syndrome.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method