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    Summary
    EudraCT Number:2009-011000-34
    Sponsor's Protocol Code Number:CAIN457F2201
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-09
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2009-011000-34
    A.3Full title of the trial
    A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate
    A.3.2Name or abbreviated title of the trial where available
    F2201
    A.4.1Sponsor's protocol code numberCAIN457F2201
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbernot available
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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.3.1Product nameAIN457
    D.3.2Product code AIN457
    D.3.4Pharmaceutical form Powder for 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.3.8INN - Proposed INNnot available
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeAIN457
    D.3.9.3Other descriptive namerhumAb to Il-17A (IgG1-k-class)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant human monoclonal antibody to Interleukin-17A of the IgG1/kappa-class
    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 placeboPowder for solution 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
    Moderate to severe Rheumatoid Arthritis.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    Efficacy of AIN457 at 16 weeks on ACR20 response.
    E.2.2Secondary objectives of the trial
    1. Speed of onset of response based on ACR20 and ACR50 at 2, 4 and 8 weeks.

    2. Response to treatment (ACR 50/70, DAS 28) compared to placebo at week 16.

    3. Effect of AIN457 on ACR components, including hsCRP and ESR to placebo.

    4. Immunogenicity of AIN457.

    5. PK/PD of AIN457 to support the decision making for the posology of Phase III.

    6. Overall safety and tolerability of AIN457.

    7. Efficacy of AIN457 on QoL and fatigue at weeks 0,2,4,8,12,16, (SF 36 & FACIT-Fatigue).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Male or non-pregnant, non-lactating females at least 18 years of age.

     Presence of RA classified by ACR 1987 revised criteria. Patients with active RA must currently be treated with a stable dose of MTX (≥7.5 mg/week - ≤25 mg/week) for at least 4 weeks. The should have been traeted with MTX for at lest 3 months.

     At Baseline: Disease activity criteria defined by ≥6 out of 28 tender joints and ≥6 out of 28 swollen joints. WITH either a. Screening value of hsCRP ≥ 10 mg/L b. OR ESR ≥28 mm/1st hr

     Patients who failed any DMARD including biologic DMARDs and any DMARDs used in combination with MTX will be allowed entry into study after appropriate wash-out period (except for MTX) prior to baseline:

    28 days for DMARDs , except for leflunomide, which has to be discontinued for 8 weeks prior to baseline unless a cholestyramine washout has been performed.

    7 days for Kineret – with a terminal half-life of 4 to 6 hours (s.c. route).

    4 weeks for Enbrel – with a terminal half-life of 102 ± 30 hours (s.c. route).

    8 weeks or longer for Remicade – with a terminal half-life of 8.0-9.5 days (i.v. infusion).

    12 weeks for Humira – with a terminal half-life of 10-20 days (average 2 weeks) (s.c. route).

    12 weeks for Orencia – with a terminal half-life of 13.1 (8-25) days (i.v. infusion).

    26 weeks for any other biologic – or 10 half-lives, which ever is longer.

     Patients taking systemic corticosteroids have to be on a stable dose of ≤10 mg/d prednisone or equivalent for at least 4 weeks before randomization.

     Patients who are regularly taking NSAIDs or COX-2 inhibitors or paracetamol/ acetaminophen as part of their RA therapy must be on a stable dose for at least 4 weeks before randomization.

     Patients taking NSAIDs or COX-2 inhibitors or paracetamol/acetaminophen PRN within 2 weeks before randomization have to stop their medication at least 24 hours before an ACR visit

     Patients taking folic acid supplementation have to be on stable dose for at least 4 weeks before randomization.

     All patients receiving current vaccinations, especially influenza and pneumococcal as clinically indicated can be included.
    E.4Principal exclusion criteria
     RA patients functional status class IV classified according to the ACR 1991 revised criteria

     Patients taking high potency opiod analgesics (e.g., methadone, hydromorphone, or morphine)

     Any therapy by i.a. (e.g. steroids) required for treatment of acute RA flare within 4 weeks before randomization.

     Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)

     WCBP, defined as all women physiologically capable of becoming pregnant, UNLESS using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some IUDs, Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable

     Males who do not consent to practice contraception during study (for details see protocol).

     Inflammatory diseases other than RA that might confound the evaluation of the benefit of AIN457, thus other rheumatic diseases that could confound the evaluation of efficacy, including but not limited to primary fibromyalgia, ankylosing spondylitis, Lyme disease, adult JRA,SLE, gout and pseudo gout, vasculitis, PsA, reactive arthritis, primary Sjoegren’s, and Behcet’s.

     Underlying metabolic, hematologic, pulmonary, neurologic, encocrine renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for participation in an immunodulatory therapy. In particular, clinical evidence or history of Felty’s syndrome.

     With significant medical problems, including but not limited to the following: uncontrolled hypertension (≥160/95 mmHg), congestive heart failure [NYHA III or IV ].

     Active systemic infections during the last two weeks (exception: common cold) prior to randomisation.

     History of, or ongoing, chronic or recurrent infectious disease or evidence of previous tuberculosis infection. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations. Prior to study entry all patients will be tested for tuberculosis status according to local guidelines

     Known infection with HIV, HEP B or C at screening or randomisation..

     History of lymphoproliferative disease or any known malignancy or history of malignancy within the past 5 years (except for non-melanoma skin cancer that has been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix, colon polyps with non-invasive malignancy that have been removed).

     Current severe progressive or uncontrolled disease which in the judgment of the clinical investigator renders the patient unsuitable for the trial.

     Inability or unwillingness to undergo repeated venipuncture (e.g., because of poor tolerability or lack of access to veins).

     Any medical or psychiatric condition which, in the Investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.

     Donation or loss of 400 mL or more of blood within 8 weeks before dosing.

     History orevidence of ongoing drug/alcohol abuse, or history thereof within the last six months before first study drug administration

     Previous exposure to AIN457 (or other biologics targetibng IL-17 or IL-17R or use of any investigational drug other than RA therapy and/or devices at the time of randomization or within 30 days or 5 half-lives of randomisation, whichever is longer.

     Plan for admin of live vaccines during study or 6 wks prior to first drug administration.
    E.5 End points
    E.5.1Primary end point(s)
    ACR20 at 16 weks.
    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 No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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) No
    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 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 EEA32
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 156
    F.4.2.2In the whole clinical trial 200
    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)
    No plans
    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 Decision2009-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-03-04
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