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    Summary
    EudraCT Number:2006-005466-39
    Sponsor's Protocol Code Number:104RA202
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-22
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2006-005466-39
    A.3Full title of the trial
    A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy
    A.4.1Sponsor's protocol code number104RA202
    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 SponsorBiogen Idec Ltd
    B.1.3.4CountryUnited Kingdom
    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 BG9924
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 (RA)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    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
    To evaluate the efficacy of 5 dose regimens of BG9924 when administered in combination with MTX to subjects with active RA who have had an inadequate response to conventional DMARD therapy. The primary efficacy outcome measure is the proportion of subjects with ACR50 at Week 14. To achieve ACR50 response, a 50% improvement compared to baseline is required for both swollen and tender joint counts, as well as 3 out of 5 additional parameters: subject’s global assessment of disease activity, Investigator’s global assessment of disease activity, subject’s assessment of pain, HAQ-DI, and hsCRP or ESR.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study are as follows:
    - To assess the safety and tolerability of these 5 dose regimens of BG9924 in this patient population.
    - To assess the PK and PD profile of these 5 dose regimens of BG9924 in this patient population.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Study sites may choose to participate in an optional PK sub-study. Approximately 50 consenting subjects will have 6 additional visits following Visits 1 (Visits 1a and 1b), 3 (Visit 3a), and 8 (Visits 8a, 8b, and 8c). Blood samples for FACS analysis will also be taken from subjects participating in this sub-study.
    Objectives:
    -To assess the PK and PD profile of these 5 dose regimens of BG9924 in this patient population.
    E.3Principal inclusion criteria
    Candidates must meet the following eligibility criteria at Day 0 (Visit 1/Week 0):
    1. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]).
    2. Aged 18 to 75 years old, inclusive, at the time of informed consent.
    3. Must have a diagnosis of adult onset RA according to the 1987 Revised American Rheumatism Association Criteria for the Classification of Rheumatoid Arthritis (Functional Class I–III) (Appendix A) for at least 6 months prior to Day 0.
    4. Must have been treated with, and be tolerating, MTX (> or=10 mg/week to < or =25 mg/week) for at least 3 months immediately prior to Day 0. The dose of MTX must be stable for at least 4 weeks prior to Day 0.
    5. Must have had an inadequate response to at least 1 conventional DMARD therapy (i.e., MTX, leflunomide, sulfasalazine, etc.) due to inadequate efficacy or toxicity.
    6. Must have a Swollen Joint Count (SJC) > or =8 and a Tender Joint Count (TJC)> or =8 (66/68 joint count at Screening).
    7. Must have elevated hsCRP > or =1.5 times the upper limit of normal (ULN) or ESR > or = 28mm/hr at Screening.
    8. Must be willing to receive oral folate (> or =5 mg/week) for the duration of the study.
    E.4Principal exclusion criteria
    MEDICAL HISTORY 1. Subjects (S) body weight <50kg 2. S hist of malignancy/ carcinoma in situ (S with hist of excised or treated basal cell carcinoma are eligible to participate in this study) 3.S a mole or lesion currently undiagnosed, but suspicious for malignancy. Any suspicious skin lesion should be evaluated and excised by a dermatologist prior to inclusion in the study 4.Hist of clin sign (as det by Inv) cardiac, allergic, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal or hematologic insufficiency, or any major disease that could affect any of the efficacy assessments, in particular, joint pain and swelling (e.g. Parkinsons disease, cerebral palsy, diabetic neuropathy) 5.S with rheumatic autoimmune disease other than RA, or sign syst involvement sec to RA (incl, but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome). Sec Sjogren's syndrome or secondary limited cutaneous vasculitis within RA is permitted 6.Serious local infection (e.g. cellulitis, abscess) or syst inf (e.g. pneumonia, septicemia) within 3M prior to D0 (V1/W0) 7.Hist of recurrent inf requiring oral/parental anti-inf drug treatment 8.Prim/sec immunodef (history of/currently active), including history of HIV infection 9.History of TB or pos purified protein derivative (PPD; pos Mantoux test >or=10 mm of induration [size of raised lump, not redness], or equivalent positive TB test result as per country clin standards) during the screening period. When PPD induration is >or=5 mm, but <10 mm the S is eligible for study if they have had a negative chest x-ray during the screening period. There must be no other clin evidence of TB on physical examination of the S. Note: S who have had prior adequate prophylaxis treatment for latent TB with an appropriate course of isoniazid (INH) or eq, per country standards, are not excl from study participation. 10.Fever (body temp. >38°C) or sympt viral infor bact inf within 2W prior to D0 11.Receipt of live vaccine within 4W prior to D0 12.Clin sign chest x-ray abnormality at Screening (Note: chest x-ray not required if one perf within 3M of D0)
    LAB. TESTS 13.S with any lab test result at Screening considered clin sign (as determined by the Inv) or o AST or ALT >1.5 times than ULN established by the central lab o Platelet count <150,000/μL o Hemoglobin <8.5 g/dL o Neutrophils <1.5 x 10exp3/μL 14.Pos hepatitis C Ab/hepatitis B [HBsAg, HbcAb/HBsAb] at Screening. Refer to full protocol for additional clarification.
    TREATMENT HISTORY 15.Previous treatment with anti-TNF therapy or any other non-TNF inhibitor biologic or prosorba column for the treatment of RA 16.If S have previously received cell-depleting therapies (incl, but not limited to, anti-CD3, anti-CD4, anti-CD5, anti-CD11a, anti-CD19, anti-CD22, and/or BlyS/BAFF), rel cell counts must have returned to normal 17.Treatment with another IMP within the 3M prior to D0 or within 5 half-lives of the agent, whichever is longer 18.Previous exposure to BG9924 19.Treatment with following concomitant medications: o Any oral steroid exceeding 10 mg/day of prednisone/eq adm within 4W prior to D0 or any oral steroid < or = 10mg/D of prednisone or eq that was not administered at a stable dose for at least 4W prior to D0 o Leflunomide adm within 8W prior to D0 (if S received 11D of stand cholestyramine/activated charcoal washout, treatment with leflunomide may not be adm within 14D prior D0) o Cyclosporin A adm within 6M prior to D0 o Azathioprine or 6-MP adm within 28D prior to D0 o Hydroxychloroquine sulfate or sulfasalazine (or equivalents), or any other allowed concomitant DMARDs, adm at doses greater than the recommended therapeutic dose or not administered at a stable dose for 4W prior to D0 o Any NSAIDS not adm at a stable dose for least 2W prior to D0 o IA corticosteroid inj within 4W prior to D0 20.S who underwent any surgical proc, incl bone/joint surgery/synovectomy (including joint fusion or replacement), within 12W prior to D0 or who are planning an unapproved (by BIIB) proc within 24 WKS of D0
    MISCELLANEOUS 21.Nursing mothers, pregnant women, or women who are planning to become pregnant while in the study 22.Male and female subjects of childbearing potential not willing to practice effective birth control for the duration of the study. Female S must be: (1) postmenopausal for at least 12 months, (2) surgically sterile, or (3) willing to use 2 documented forms of birth control (e.g. barrier and spermicide, intrauterine device and barrier or spermicide, or birth control pill and barrier or spermicide) 23.Blood donation (1 unit or more) within 1 month prior to Screening 24.History of drug or alcohol abuse (as determined by the Inv) within 1Y prior to D0
    25.Current enrollment in any other IMP study 26.Previous participation in this study
    27.S expected to be unavailable for duration of trial, likely to be noncompliant with protocol, or who are felt to be unsuitable by Inv/Sponsor for any other reason
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects with an ACR50 response at Week 14 (Visit 8).
    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 Information not present in EudraCT
    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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 138
    F.4.2.2In the whole clinical trial 380
    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)
    2 weeks after the last dose (Visit 8, at Week 14) patients will be offered the option to enter a long-term safety extension study under a separate protocol.
    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 Decision2007-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-10-09
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