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    Summary
    EudraCT Number:2006-001550-27
    Sponsor's Protocol Code Number:CACZ885A2201
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-19
    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 ConcernedGermany - PEI
    A.2EudraCT number2006-001550-27
    A.3Full title of the trial
    A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate
    A.4.1Sponsor's protocol code numberCACZ885A2201
    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 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 nameACZ885
    D.3.2Product code ACZ885
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeACZ885
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 typemonoclonal antibody
    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 and solvent 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
    Active Rheumatoid Arthritis
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of three dose regimens of ACZ885 ( (1) 600 mg i.v. loading dose plus 300 mg s.c. q2wk, (2) 300 mg s.c. q2wk, (3) 150 mg s.c. q4wk) compared to placebo as add-on treatment in patients with active RA despite stable treatment of MTX at the maximum tolerated dose (<_ 25 mg/week) for at least 12 weeks, by assessing the response to treatment (ACR50 criteria) after 12 weeks.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of ACZ885 by assessing the response to treatment (ACR20 and ACR70 criteria, DAS28) compared to placebo.

    The onset of effect will also be assessed based on ACR20 and ACR50 at 2, 4, and 8 weeks.

    To assess the effect of ACZ885 on ACR components, including a marker of inflammation (hsCRP) compared to placebo after 12 weeks.

    To assess the immunogenicity of ACZ885 after 12 weeks of repeat exposure.

    To explore markers of cartilage and bone turnover for potential relationship with clinical response.

    To assess the PK/PD of ACZ885.

    To conduct exploratory pharmacogenetic and pharmacogenomic analysis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cooperative male or non-pregnant, non-lactating female patients at least 18 years of age. Who signed an informed consent before the initiation of any study procedure. Diagnosis of RA classified by ACR 1987 revised criteria (Appendix 3) and with symptoms for at least 3 months before randomization. Functional status class I, II or III classified according to the ACR 1991 revised criteria. Patients treated with MTX at the maximum tolerated and stable dose of ≥7.5 and ≤25 mg/week for
    at least 12 weeks before randomization. Patients who failed any DMARDs (including biologic agents and any DMARD used in combination with MTX) will be allowed. For patients with previous treatment with biological therapy, the following wash-out periods are required before randomization: 3 days for Kineret® (anakinra) – with a terminal half-life of 4 to 6 hours (s.c. route). 4 weeks for Enbrel® (etanercept) – with a terminal half-life of 102 ± 30 hours (s.c. route). 8 weeks for Remicade® (infliximab) – with a terminal half-life of 8.0-9.5 days (i.v. infusion). 12 weeks for Humira® (adalimumab) – with a terminal half-life of 10-20 days (average 2
    weeks) (s.c. route). 12 weeks for Orencia® (abatacept) – with a terminal half-life of 13.1 (8-25) days (i.v. infusion). 26 weeks for any other biologic – or 10 half-life, 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 using 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. Pts taking NSAIDs or COX-2 inhibitors or paracetamol/ acetaminophen PRN within 2 wks 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 current vaccinations, especially influenza and pneumococcal as clinically indicated. Weight ≥45 kg and BMI <34.0. Women of non-child-bearing potential (WOCBP), defined as all women physiologically not capable of becoming pregnant and females who are neither pregnant (β-hCG serum pregnancy test negative) nor lactating, and are either: surgically sterilized (tubal ligation or hysterectomy), postmenopausal for at least 24 months past last natural menses, postmenopausal with last natural menses in the past 24 months, and with an FSH >40 IU/L and serum estradiol <18 pg/ml, or with an FSH ≤40 IU/L and serum estradiol ≥18 pg/ml, and using an acceptable form of birth control, will be eligible.
    At baseline (Visit3)
    1. Disease activity criteria of ≥6 out of 28 tender joints and ≥6 out of 28 swollen joints.
    One of the following must also be present:
    2. a) High sensivity C-reactive protein (hsCRP) concentration ≥10 mg/L
    b) ESR ≥28 mm/1st hr
    a) + b) are based on screening (SCR) values
    E.4Principal exclusion criteria
    1. History of hypersensitivity to study drug or to molecules with similar structures. Any therapy by intra-articular injections (e.g. corticosteroid) required for treatment of acute RA flare within 4 weeks before randomization. Current use of DMARDs other than MTX. DMARDs include but are not limited to: biologic agents, thiolates (D-penicillamine, thiopronine), sulfasalazine, gold compounds, antimalarials, cyclosporine
    A, azathioprine, leflunomide, and alkylating agents such as cyclophosphamide. If a patient has been discontinued from DMARDs, the patient should be off the agent for at least 4 weeks, except leflunomide which is 8 weeks. Patients with evidence of active pulmonary disease (e.g. tuberculosis, fungal diseases). Donation or loss of 400 mL or more of blood within 8 weeks before dosing. Who have had a live vaccination within 12 weeks before randomization, or are planning to have one during the study and not willing/able to postpone until study completion. With bacterial, fungal or viral infections at the time of enrollment, including patients with
    evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection. History of a positive purified protein derivative (PPD) of tuberculin skin test without action being taken such as documentation of prior BCG (bacille Calmette Guerin) immunization or the completion of a course of adequate chemoprophylaxis for tuberculosis with a negative chest X-ray. Patients requiring administration of antibiotics against latent tuberculosis, e.g., isoniazide(course of antibiotic therapy started prior to entering the study should not be prematurely terminated to alow inclusion in the study). Underlying metabolic, hematologic, 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 multiple sclerosis or other demyelinating diseases, or Felty’s syndrome. With significant medical problems, including but not limited to the following: uncontrolled hypertension (≥160/95 mmHg), congestive heart failure [New York Heart Association status of class III or IV (see Appendix 10)], type-I-diabetes (well controlled type-II-diabetes is allowed even when requiring insulin), thyroid disease (unless the patient is taking a stable dose of thyroid hormone for at least 12 weeks) before randomization. Other rheumatic diseases that could confound the evaluation of efficacy, including but not limited to primary fibromyalgia, ankylosing spondylitis, Lyme disease, adult JRA, systemic lupus erythematosus, gout and pseudo gout, vasculitis, psoriatic arthritis, reactive arthritis, primary Sjoegren’s Syndrome, and Behcet’s Syndrome. 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. History of malignancy of any organ system, treated or untreated, within the past 5 years (with the exception of adequately treated basal cell carcinoma or squamous-cell carcinoma of the skin, carcinoma in situ of the cervix, colon polyps with non-invasive malignancy that have been removed). 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 randomization, whichever is longer.
    E.5 End points
    E.5.1Primary end point(s)
    See under Main Objective of the Trial.
    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 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) 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    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 months4
    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 months4
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-10-19. Yes
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 293
    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)
    1 year open label extension phase planned
    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 Decision2007-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-23
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