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    Summary
    EudraCT Number:2011-004171-36
    Sponsor's Protocol Code Number:S101-RGL-003
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-11-30
    Trial 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 ConcernedCzechia - SUKL
    A.2EudraCT number2011-004171-36
    A.3Full title of the trial
    A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)
    Randomizované, dvojitě zaslepené, multicentrické hodnocení s paralelními skupinami, porovnávající účinnost, bezpečnost, farmakodynamiku a farmakokinetiku přípravku SAIT101 s přípravkem MabThera® u pacientů s aktivní formou revmatoidní artritidy (RA).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)
    A.4.1Sponsor's protocol code numberS101-RGL-003
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSamsung Electronics Co. Ltd.
    B.1.3.4CountryKorea, Republic of
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSamsung Electronics Co. Ltd.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles Limited
    B.5.2Functional name of contact pointQuintiles Contact Centre
    B.5.3 Address:
    B.5.3.1Street AddressThe Alba Campus, Rosebank
    B.5.3.2Town/ cityLivingston
    B.5.3.3Post codeEH54 7EG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+1862261 3634
    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 No
    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 nameSAIT101
    D.3.2Product code SAIT101
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeSAIT101
    D.3.9.3Other descriptive nameChimeric human/mouse anti-CD-20 monoclonal antibody
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe Rheumatoid Arthritis (RA)
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis (RA)
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to compare the efficacy of SAIT101 to MabThera® in subjects with severe RA.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to compare the pharmacodynamics (PD), safety, tolerability and immunogenicity of SAIT101 to MabThera® in subjects with severe RA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability and willingness to provide written informed consent, prior to any study specific procedures, and to comply with the requirements of the protocol.
    2. Male or female outpatient, at least 18 years of age at Screening.
    3. Severe active RA defined as:
    (a) Diagnosis of RA according to the revised (1987) ACR criteria for the classification of RA for at least 3 months prior to study entry (see Appendix 3).
    (b) Radiological confirmation of bone erosion (X-ray. Existing evidence [X-ray not more than 1 year old] also accepted).
    (c) ≥ 6 swollen joints and ≥ 6 tender/painful joints (from the 66/68 joint count system).
    (d) hsCRP ≥ 1.0 mg/dL and/or an ESR ≥ 28 mm/hour at Screening.
    (e) Positive RF (≥ 20 units/mL) and/or anti CCP antibodies (≥ 10 units/mL) at Screening.
    4. Currently receiving, or have previously received, DMARDs, including one or more TNF inhibitor therapies, for the treatment of RA at a label approved dose for at least 3 months, and have had an inadequate or intolerable response to at least one of those administrations. NB: All biologic DMARDs and IL-1 and IL-6 inhibitors are subject to a washout period prior to randomization (see Table 7).
    5. Current treatment for RA on an outpatient basis:
    (a) Receiving MTX 10-25 mg/week (oral or parenteral) for at least 3 months, including the last 1 month prior to randomization at a stable dose, via the same route of administration and formulation. Subjects receiving a lower dose of MTX (< 10 mg/week), stable for 1 month prior to randomization, should be doing so as a result of a documented evidence of intolerance to higher doses of MTX.
    (b) Subjects may be taking oral hydroxychloroquine provided that the dose is not greater than 400 mg/day and has been stable for a minimum of 3 months prior to Day 1. The hydroxychloroquine treatment will need to be continued at a stable dose with the same formulation until the end of the study.
    (c) Leflunomide must be withdrawn at least 3 months prior to the beginning of the treatment period or a minimum of 1 month prior to the beginning of the treatment period if after 11 days of standard cholestyramine washout.
    (d) All DMARDs different from MTX, hydroxycholoquine and leflunomide must be withdrawn at least 1 month prior to the beginning of the treatment period.
    (e) If receiving current treatment with oral corticosteroids, the dose must not exceed 10 mg/day prednisolone or equivalent. During the 1 month prior to Day 1 the dose must be stable (see Section 5.1.3).
    (f) The most recent steroid injection should be ≥6 weeks prior to Day 1.
    (g) If receiving current treatment with NSAIDs at the time of Screening, the subject must remain on a stable dose for at least 3 weeks prior to Day 1.
    (h) Subjects are willing to receive oral folic acid (at least 5 mg/week) or equivalent during the entire study (mandatory co-medication for MTX treatment).
    6. For subjects of reproductive potential (males and females), use of a reliable means of contraception (e.g., hormonal contraceptive, patch, intrauterine device, physical barrier) during the course of the treatment period and for at least 12 months after the last dose of investigational product.
    7. Female subjects of childbearing potential must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at each applicable visit thereafter.
    8. Female subjects must not be actively breast-feeding throughout the entire study period and until 12 months after their final dose with investigational product.
    E.4Principal exclusion criteria
    1. Females who are pregnant, nursing, or planning a pregnancy during the period of the study.
    2. American College of Rheumatology functional Class IV or wheelchair/bed bound.
    3. Have any significant systemic involvement with RA such as vasculitis, pulmonary fibrosis or Felty’s syndrome.
    4. History of or current inflammatory joint disease other than RA (including but not limited to gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy or Lyme disease) or other systemic autoimmune disorder, with the exception of the secondary Sjögren's syndrome, (including but not limited to systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome).
    5. History of infected prosthetic joint.
    6. Positive serological test for HBsAg and HBcAb or for hepatitis C serology.
    7. History of HIV infection.
    8. History of active/latent TB, as determined by TB test.
    9. Subjects with acute clinical manifestations of herpes zoster virus.
    10. Subjects with history of severe herpes zoster defined by involvement of more than one dermatome, ophthalmic involvement and/or requiring hospital admission within 5 years prior to Baseline.
    11. Active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization within 3 months prior to Baseline or requiring treatment with i.v. anti infective agents within 6 weeks prior to Baseline or oral anti-infective agents within 2 weeks prior to Baseline.
    12. Any significant cardiac disease (e.g. coronary artery disease with unstable angina, coronary heart failure NYHA Class III and IV, familial long QT syndrome, uncontrolled cardiac disease).
    13. History of moderate to severe COPD and/or history of severe COPD exacerbation(s) within the last 12 months.
    14. Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids.
    15. Administration of a live/attenuated vaccine in the 1 month prior to randomization.
    16. History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the investigational product.
    17. Hypogammaglobulinemia (IgG < 5.0 g/L and/or IgM < 0.20 g/L).
    18. Subjects having undergone a splenectomy.
    19. Subjects with hemoglobin < 8.5 g/dL, WBC count < 3000 cells/µL, ANC < 2000 cells/µL, lymphocyte count < 800 cells/µL or platelet count < 100,000 cells/µL at Screening. If a subject has findings marginally below this limit, re testing is allowed, at the investigator’s discretion, within the 30 day period between Visit 1 and 2.
    20. AST, ALT, GGT or alkaline phosphatase levels > 1.5 times (for Part A) or > 3 times (for Part B) the ULN at Screening or serum creatinine > 2 times ULN. The AST and ALT may be repeated once within the Screening period if the initial result exceeds this limit, and the lesser value accepted if it meets this criterion.
    21. Subjects with a history of solid-organ transplantation.
    22. History of cancer within the last 5 years treated with anti-cancer chemotherapy, including solid tumors and hematologic malignancies and carcinoma in situ (except basal cell and squamous cell carcinomas of the skin or carcinoma in situ of the cervix uteri that have been excised and cured).
    23. Subjects with a current or past history of alcohol or drug abuse.
    24. Any surgical procedure within 3 months prior to Baseline, with the exception of surgical procedures for dental prosthesis.
    25. Previous treatment with a B cell modulating or B cell depletion therapy, such as, but not limited to: rituximab, belimumab, ocrelizumab and other experimental treatments.
    26. Injectable corticosteroids within 6 weeks prior to Baseline.
    27. Participation in a previous clinical study within 3 months of Screening. Subjects who have received treatment with a drug that has not received regulatory approval for any indication within 3 months or a minimum of 5 half-lives, whichever is longer, of the initial dose of investigational product.
    28. Subjects who, based on the investigator’s judgment, have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation, such as diabetes mellitus type 1 or unstable type 2. Conditions may also include cardiovascular, vascular disease, pulmonary, hepatic, renal, or neurological as determined by medical history, physical examination, laboratory tests or ECG.
    29. Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study.
    30. Subjects who have participated in any clinical study involving SAIT101.
    E.5 End points
    E.5.1Primary end point(s)
    • The primary PK endpoints for Part A are the area under the concentration-time curve from time 0 (immediately pre-dose at Day 1) to the time of the last quantifiable concentration (AUC0-t) at Week 24 and the maximum concentration (Cmax) post infusion on Day 15.
    • The primary efficacy variable for the whole study is the ACR20 response rate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • AUC time curve from time 0 (immediately pre-dose at Day 1) to the time of the last quantifiable concentration (AUC0-t) at Week 24 and Cmax post infusion on Day 15.
    • ACR20 response rate at Week 24.
    E.5.2Secondary end point(s)
    • ACR20 response rates.
    • ACR50 response rate and ACR70 response rate.
    • Individual components of the ACR improvement criteria:
    o Swollen and tender joint count (the 66/68 joint count system)
    o Subject’s assessment of pain (assessed on 1-100 mm Visual Analogue Scale [VAS])
    o Physician’s global assessment of disease activity (assessed on 1-100 mm VAS)
    o Subject’s assessment of disease activity (assessed on 1-100 mm VAS)
    o Subject’s assessment of disability (Health Assessment Questionnaire Disability Index)
    o C-reactive protein level
    • Change in the DAS28.
    • Major clinical response (continuous ACR70).
    • Proportion of subjects with European League Against Rheumatism response (good response, moderate response or no structural joint damage).
    • Assessment of structural joint damage.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • ACR20 response rates at Weeks 4, 8, 12, 16 and 52.
    • ACR50 response rate and ACR70 response rate at Weeks 4, 8, 12, 16, 24 and 52.
    • Individual components of the ACR improvement criteria at Day 1 and at Weeks 4, 8, 12, 16, 24 and 52:
    • Change in the DAS28 from Baseline to Weeks 4, 8, 12, 16, 24 and 52.
    • Major clinical response (continuous ACR70 for at least 24 weeks).
    • Proportion of subjects with European League Against Rheumatism response at Weeks 4, 8, 12, 16, 24 and 52.
    • Assessment of structural joint damage at Screening and Week 52.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Yes
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Canada
    Korea, Republic of
    Mexico
    Romania
    Russian Federation
    South Africa
    Switzerland
    Taiwan
    Turkey
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 496
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 245
    F.4.2.2In the whole clinical trial 616
    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)
    After the end of the study, the study drug will no longer be available to the patients. Patients continued care may involve a different drug or treatment, which the hospital, together with the Study Doctor, consider the most suitable alternative
    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 Decision2012-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-06-30
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