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    Summary
    EudraCT Number:2009-016266-90
    Sponsor's Protocol Code Number:EFC11072
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-07-26
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2009-016266-90
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy
    A.3.2Name or abbreviated title of the trial where available
    MOBILITY
    A.4.1Sponsor's protocol code numberEFC11072
    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 SponsorSanofi-aventis Recherche & Développement
    B.1.3.4CountryFrance
    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 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 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.3.2Product code SAR153191
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSAR153191
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    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 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) Yes
    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.IMP: 2
    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.3.2Product code SAR153191
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSAR153191
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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) Information not present in EudraCT
    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 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) Yes
    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.IMP: 3
    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.3.2Product code SAR153191
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSAR153191
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 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) Yes
    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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid Arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A:
    To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks
    Part B:
    To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of RA at 24 weeks
    E.2.2Secondary objectives of the trial
    Part B:
    To demonstrate that SAR153191 on top of MTX is effective on:
    - inhibition of progression of structural damage at 52 weeks
    - improvement in physical function at 52 weeks
    - induction of a major clinical response at 52 weeks
    To assess the safety of SAR153191 on top of MTX
    To document the PK profile of SAR153191 on top of MTX, in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To collect DNA, RNA and other biomarkers for future use for the purpose of discovery of predictive biomarkers.
    Version 1
    19 October 2009
    E.3Principal inclusion criteria
    I 01. Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with disease duration of no less than 3 months and ACR class I-III.
    I 02. Patients must be on a stable dose of MTX (10 to 25 mg/week) for a minimum of 6 weeks prior to the Screening Visit and intend to continue for the duration of the study.
    I 03. Patients must have been treated with, and tolerated, a minimum of 12 weeks treatment with methotrexate (MTX) prior to the inclusion visit.
    I 04. Patient with moderate to severe active disease defined as:
    - At least 8 out of 68 joints assessed as painful or tender on motion at both screening and baseline visits, and,
    - At least 6 out of 66 joints assessed as swollen at both screening and baseline visits,and,
    - hs C-Reactive Protein >10mg/L at screening visit
    I 05. Part B only:
    - At least one locally documented bone erosions (on X-ray) prior to first study drug
    dosing
    - Or, anti CCP antibody positive according to screening laboratory tests
    - Or, positive rheumatoid factor according to screening laboratory tests.
    I 06. Having signed a written informed consent prior to any procedure related to the study.
    E.4Principal exclusion criteria
    E 01. Male or female <18 years of age or >75 years
    E 02. Weight <50kg for men or <45kg for women or >110 kg
    E 03. Autoimmune disease other than RA or significant systemic involvement
    E 04. History of or current acute inflammatory joint disease other than RA, or RA diagnosed before the age of 16.
    E 05. Treatment with oral prednisone or equivalent >10mg per day within 4 weeks prior to the Inclusion Visit or Use of parenteral or intra-articular glucocortisteroids within 4 weeks prior to the Screening Visit
    E 06. Start treatment or change dose of current treatment with NSAIDs/COX2 inhibitors or oral corticosteroids for 4 weeks prior to baseline.
    E 07. Current treatment with DMARDS/immunosuppressive agents other than MTX.
    E 08. Past history of non response to prior therapy with TNF antagonist or a biologic treatment.
    E 09. Prior therapy with a TNF antagonist or any other biologic agents within 3 months prior to inclusion.
    E 10. Participation in any clinical research study evaluating another investigational drug or therapy within 60 days or at least 5 half-lives, whichever is longer, of the investigational drug, prior to the Screening Visit
    E 11. History of malignancy other than carcinoma in-situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin within five years prior to Screening Visit. History of lymphoproliferative disease or possible current lymphoproliferative disease.
    E 12. History of alcohol or drug abuse within the 5 years prior to the Screening Visit.
    E 13. Have a history or presence of significant other concomitant illness according to the Investigator judgment.
    E 14. Conditions/situations such as:
    - Patients with short life expectancy
    - Patients with conditions/concomitant diseases making them non-evaluable for the
    primary efficacy endpoint
    - Requirement for concomitant treatment that could bias primary evaluation
    - Impossibility to meet specific protocol requirements (e.g. need for hospitalization, etc)
    - Patient is the Investigator or any sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
    - Uncooperative or any condition that could make the patient potentially non-compliant with the study procedures
    E 15. Patients not willing to take folic acid with the MTX dose, to minimize toxicity
    E 16. Pregnant or breast-feeding women,
    E 17. Previous exposure to SAR153191
    E 18. For women of childbearing potential, unwillingness to utilize adequate contraception or not become pregnant during the full course of the study.
    E 19. Any subject who has had surgery within 4 weeks prior to the Screening Visit or with planned elective surgery.
    E 20. Patients with a latent or active tuberculosis (TB) defined as:
    - Any signs or symptoms suggestive of active TB upon medical history or clinical
    examination.
    - Subjects with a positive QuantiFERON, TB gold test or tuberculin test (PPD skin test
    ≥10mm) at screening. (see Section 10.2).
    - Chest radiograph within 3 months prior to the inclusion visit.
    - Subjects with close contact with a person with active tuberculosis.
    E 21. Patients with a history of resolved Listeria or tuberculosis (unless documented adequately treated).
    E 22. Fever (≥38°C) or persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit, or history of frequent recurrent infections unacceptable per investigator judgment.
    E 23. Non-healed infected skin ulcers.
    E 24. Received administration of any live (attenuated) vaccine within 3 months prior to the inclusion Visit (e.g. varicella-zoster vaccine, oral polio, rabies).
    E 25. Received vaccination by BCG within 12 months prior to screening.
    E 26. Known history of Human Immunodeficiency Virus (HIV) antibody; and/or positive
    Hepatitis B surface antigen (HBsAg), and/or positive Hepatitis C antibody (HCV) at the Screening Visit.
    E 27. History of recurrent herpes zoster or active herpes zoster infection.
    E 28. History of prior articular or prosthetic joint infection
    E 29. History of a hypersensitivity reaction, other than localized injection site reaction (ISR), to any biological molecule
    E 30. History of a hypersensitivity reaction to doxycycline, tetracycline or related compounds.
    E 31. Uncontrolled diabetes, defined as HbA1c ≥9.0% at the Screening Visit
    E 32. History of demyelinating disease
    E 33. Patients on dialysis
    E 34. Presence of any of the following laboratory abnormalities (for the central laboratory conducting the test) at the Screening Visit:
    - Hemoglobin <8.5g/l
    - WBC <3000/μL
    - platelet count <100,000/μL
    - neutrophils <2000/μL
    - AST or ALT >1.5 ULN
    - Bilirubin >1.5 ULN unless patient diagnosed with Gilbert disease - Creatinin clearance <30ml/mn
    E 35. For men who are unwilling to utilize two forms of contraception a condom and a spermicidal agent.
    E.5 End points
    E.5.1Primary end point(s)
    Part A:
    Percentage of patients who achieved ACR20 at week 12
    Part B:
    Percentage of patients who achieved ACR20 at week 24
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months39
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months39
    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.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 544
    F.4.2.2In the whole clinical trial 1740
    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 Decision2010-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-03
    P. End of Trial
    P.End of Trial StatusOngoing
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