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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-005918-20
    Sponsor's Protocol Code Number:Protocol nr. ITP 001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-10-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2005-005918-20
    A.3Full title of the trial
    Rituximab as second line treatment for ITP:
    A Multicentre, Randomized, Double blind,Placebo-controlled, Phase III study.
    “The RITP study”
    A.3.2Name or abbreviated title of the trial where available
    “The RITP study” Protocol version 5
    A.4.1Sponsor's protocol code numberProtocol nr. ITP 001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRikshospitalet
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name MabThera®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMabThera
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Immune thrombocytopenic purpura (ITP).
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess in both treatment arms the rate of splenectomy at 1.5 years.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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.
    E.4Principal 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) (> 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.
    E.5 End points
    E.5.1Primary end point(s)
    To assess in both treatment arms the rate of splenectomy at 1.5 years.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.6.13.1Other scope of the trial description
    1- Response rates 2- Relapse rates and
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Primary end point: A splenectomy during the follow-up period after randomisation.

    Secondary endpoints: 1-Death during follow-up period 2-Relapse defined as platelet count <30 x 109/l following an initial response and duration of response. 3- Episodes of bleeding, infection and thromboembolic events.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Information not present in EudraCT
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 110
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not applicable. Study treatment, consisting of 4 courses of either rituximab or placebo will be applied only once during the study. Thus,the participants will only receive the study drug during their participation in the study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-14
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