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    Summary
    EudraCT Number:2008-007784-16
    Sponsor's Protocol Code Number:IL1T-GA-0815
    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:2009-03-10
    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 number2008-007784-16
    A.3Full title of the trial
    A Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of the Safety of Rilonacept for the Prophylaxis of Gout Flares in Patients on Urate Lowering Therapy.
    A.4.1Sponsor's protocol code numberIL1T-GA-0815
    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 SponsorRegeneron Pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    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 Yes
    D.2.1.1.1Trade name ARCALYST™
    D.2.1.1.2Name of the Marketing Authorisation holderRegeneron Pharmaceuticals Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 namerilonacept
    D.3.4Pharmaceutical form Powder 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 INNrilonacept
    D.3.9.1CAS number 501081-76-1
    D.3.9.2Current sponsor coderilonacept (USAN)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Information not present in EudraCT
    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 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
    Gout flares
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064900
    E.1.2Term Gout flare
    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 this study is to assess the safety and tolerability of 160 mg of subcutaneous (SC) therapy with rilonacept in the prophylaxis of gout flares in subjects on urate lowering therapy.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of rilonacept as seen in clinical practice
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female 18 – 80 years of age
    2.Previously met the preliminary criteria of the American Rheumatism Association (ARA) for the classification of the acute arthritis of primary gout (if any 6 or more of the 13 criteria are present, serially or simultaneously, during any interval of observation) or monosodium urate monohydrate microcrystals have been identified in joint fluid
    3.Subjects with history of gout, initiating or currently on urate lowering therapy who are at risk of gout flare.
    -Subjects initiating urate lowering therapy at baseline with either allopurinol, probenecid, sulfinpyrazone, or febuxostat OR
    -Subjects currently on urate lowering therapy with allopurinol, probenecid, sulfinpyrazone, or febuxostat for a period of ≤ 2 months prior to baseline visit. OR
    -Subjects currently on urate lowering therapy with allopurinol, probenecid, sulfinpyrazone, or febuxostat for longer than 2 months with serum uric acid values at screening/baseline of 7.0 mg/dl or greater OR
    -Subjects currently on urate lowering therapy with allopurinol, probenecid, sulfinpyrazone, or febuxostat with evidence of tophi, regardless of serum urate level.
    4.For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during the full course of the study. Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to screening) and other prescription pharmaceutical contraceptives; IUD; bilateral tubal ligation; vasectomy; condom or diaphragm plus either contraceptive sponge, foam or jelly
    5.Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures
    6.Able to read, understand and willing to sign the informed consent form
    7.Able to read, understand, and complete study-related questionnaires and diary
    E.4Principal exclusion criteria
    1.Are pregnant, nursing, or planning a pregnancy or fathering a child within 3 months after receiving the last administration of study drug
    2.Subjects with acute gout flare in the 2 weeks prior to the Screening Visit or during Screening
    3.Have a known or suspected current active infection or a history of chronic or recurrent infectious disease including but not limited to chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, an open, draining, infected skin wound
    4.Within 2 months of first study drug administration, have had a serious infection, have been hospitalized for an infection, have been treated with PO antibiotics for greater than 2 weeks, or have been treated with IV antibiotics for an infection
    5.Subjects with chronic active gouty arthritis
    6.Evidence of prior or current infection in any affected joint
    7.Subjects with a history of inadequate urate-lowering response to allopurinol or history of allergic reaction, contraindication, or intolerance to allopurinol (for those subjects treated with allopurinol)
    8.Uncontrolled diabetes, defined as HbA1c ≥ 9.0% at the Screening Visit
    9.Subjects requiring dialysis
    10.Subjects who have had an organ transplant
    11.Treatment with any systemic immunosuppressants (e.g., methotrexate, leflunomide, etanercept, adalimumab, infliximab, abatacept, natalizumab, rituximab, cyclosporine, mycophenolate, tacrolimus, sirolimus, azathiopurine or mercaptopurine) within 6 months prior to baseline visit; anakinra within 30 days of baseline visit.
    12.Treatment with pegloticase within 6 months of baseline visit
    13.History of a demyelinating disease or symptoms suggestive of multiple sclerosis
    14.Use of oral, intraarticular (IA), intramuscular (IM), or intravenous (IV) glucocorticoids in the 4 weeks prior to the Screening Visit
    15.Use of colchicine within 14 days prior to the Screening Visit
    16.Treatment with a live (attenuated) virus vaccine during the 3 months prior to screening visit
    17.Estimated glomerular filtration rate (eGFR) < 30 mL/min for those treated with allopurinol. Follow approved prescribing information for other urate lowering agents
    18.Screening Laboratory test results meeting any of the following criteria:
    -Hemoglobin (Hgb) < 8.5 g/dL;
    -White blood cell (WBC) count < 3.0 x 103/μL ;
    -Neutrophil count < 1.5 x 103/μL
    -Platelet count < 100 x 103/μL ;
    -Total bilirubin exceeding 1.5 times the upper limit of normal unless consistent with Gilbert's syndrome.
    -AST/ALT > 2.0 x ULN [Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) exceeding 2 times the upper limit of normal]
    19.For sites in South Africa: HIV antibody positive
    For sites in all other countries: History of HIV by clinical or serological history
    20.Hepatitis B surface antigen (HBsAg) and/or Hepatitis C antibody (HCV) by serologic testing
    21.A chest radiograph that shows evidence of malignancy or any abnormalities suggestive of prior tuberculosis infection, including, but not limited to, apical scarring, apical fibrosis, or multiple calcified granulomata. This does not include non-caseating granulomata.
    22.TB criteria:
    -History of active TB prior to screening
    -Signs or symptoms suggestive of active TB (e.g. new cough of > 14 days in duration or a change in chronic cough, persistent fever, unintentional weight loss, night sweats) upon review of medical history and/or physical examination
    -Have recent close contact with a person with active TB
    -History of latent untreated TB
    23.For sites in South Africa, Indonesia, India, and Taiwan: A positive intradermal tuberculin skin test (PPD 5 TU) ≥ 10 mm induration read at 48 to 72 hours by a qualified health professional. For sites in all other countries: A positive intradermal skin tuberculin test (PPD 5 TU) ≥5 mm induration read at 48 to 72 hours by a qualified health professional
    24.Not included in form due to EudraCT character limitation, please refer to protocol.
    25.History or presence of malignancy within 5 years of the Screening Visit (other than a successfully treated non- metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix)
    26.History of a myeloproliferative disorder
    27.History of alcohol abuse or current intake of 21 or more alcohol-containing drinks per week (a alcohol containing drink is defined in study reference manual)
    28.History of drug abuse within the 5 years prior to the Screening Visit
    29.Use of benzbromarone within 3 months prior to the Baseline Visit
    30.Subjects with previous exposure to rilonacept
    31.Not included in form due to EudraCT character limitation, please refer to protocol.
    32.Not included in form due to EudraCT character limitation, please refer to protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are safety assessed by summarizing the incidences and types of treatment-emergent adverse events and changes in laboratory parameters.
    The secondary efficacy endpoints are as following:
    •The number of gout flares from Day 1 to Week 16 . The proportion of subjects with one or more gout flares from Day 1 to Week 16
    •The proportion of subjects with at least two flares from Day 1 to Week 16
    •The number of gout flare-days from Day 1 to Week 16
    For the purpose of analysis, a gout flare is defined as subject-reported acute articular pain typical a gout attack that is deemed (by the subject and/or the Investigator) to require treatment with an anti-inflammatory medicine.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 No
    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 concerned9
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Last visit of the last subject
    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 months5
    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 months5
    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 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 Information not present in EudraCT
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 1200
    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)
    Return to standard of care treatment.
    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 Decision2009-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-02-16
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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