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    Summary
    EudraCT Number:2008-004754-33
    Sponsor's Protocol Code Number:109RA201
    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:2008-11-14
    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 number2008-004754-33
    A.3Full title of the trial
    A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug Therapy
    A.4.1Sponsor's protocol code number109RA201
    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 Limited
    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.3.1Product nameBG00012
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 624497
    D.3.9.3Other descriptive nameDimeythl Fumarate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral 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 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
    The primary objective of this study is to evaluate the clinical efficacy of BG00012 with MTX in subjects with active RA who have had an inadequate response to DMARD therapy.
    E.2.2Secondary objectives of the trial
    To determine the safety and tolerability of BG00012 with MTX in this population
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must give written informed consent and any authorisations required by local law
    2. Aged 18-75 years old inclusive at time of randomisation
    3. Must have a diagnosis of adult, onset RA according to the 1987 Revised American Rheumatism Association Criteria for the Classification of Rheumatoid Arthritis (Function Class I-III) for at least 6 months prior to Day 0
    4.Must have been treated with and be tolerating MTX (≥7.5 mg/week to ≤ 25 mg/week) for at least three months immediately prior to Day 0
    5. Must have had an inadequate response to at least 1 coventional DMARD therapy (e.g. MTX, leflunomide, sulfasalazine, etc.) due to inadequate efficacy or toxicity
    6.Must have a swollen joint count (SJC) ≥6 and a Tender Joint Count (TJC) ≥6 (66/68 joint count at screening)
    7. Must have an elevated hsCRP ≥ 1.5 times the upper limit of normal (ULN) or erythrocyte sedimentation rate (ESR) ≥ 28 mm/hr at Screening
    8.Must be willing to receive oral folate (≥ 5mg/week) or folinic acid (≥1mg/week) for the duration of the study
    9. All male and female subjects of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 1 month after their last dose of study treatment
    E.4Principal exclusion criteria
    1. Subjects with a history of malignant disease, including solid tumours and haematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completed excised and are considered cured)
    2. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
    3. History of clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal or haematologic insufficiency, or any major disease that could affect any of the efficacy assessments, in particular, joint pain and swelling (e.g. Parkinson's Disease, cerebal palsy, diabetic neuropathy)
    4. Known active bacterial, viral, fungal, mycobacterial, opportunistic infection or other infection (including atypical micobacterial disease, but excluding fungal infections of the nail beds) or any major episode of infection requiring hospitalisation or treatment with intravenous (IV) antibiotics within 4 weeks of Day 0
    5. Nursing mothers, pregnant women, or women who are planning to become pregnant while in the study
    6 Treatment with another investigational drug, investigational device, or approved therapy for investigational use within three months prior to Day 0 or within 5 half-lives of the agent, whichever is longer.
    7. Previous treatment with anti-TNF treatment or any other non-TNF inhibitor biologic or prosorba column
    8. Any live immunisation/vaccination within 1 month prior to dosing.
    9. Treatment with the following concomitant medications:
    - Any oral steroid exceeding 10 mg/day of prednisone or equivalent administered within 4 weeks prior to Day 0 or any oral steroid ≤ 10 mg/day of prednisone or equvalent that was not administered at a stable dose for at least 4 weeks prior to Day 0
    - Leflunomide administered within 8 weeks prior to Day 0
    - Cyclosporin A administered within 8 weeks prior to Day 0
    - Azathioprine or 6-MP administered within 28 days prior to Day 0
    -Hydroxychloroquine sulfate or sulfasalazine, or any other allowed concomitant DMARDS administered at doses greater than the recommended therapeutic dose or not adminstered at a stable dose for 4 weeks prior to Day 0
    - Any NSAIDS not administered at a stable dose for at least 2 weeks prior to Day 0
    - Intra-articular or intramuscular corticosteroid injections given within 4 weeks prior to Day 0
    10. Previous exposure to BG00012 or FUMADERM® for RA
    11. Subjects who underwent any surgical procedure, including bone, joint, synovectomy within 12 weeks prior to Day 0 or who are planning unapproved ( by Biogen Idec) procedure within 16 weeks prior to Day 0
    12. Subjects with any laboratory test result at screening visit considered clinically significant
    13. Serum creatinine > 1.2 ULN established by the central laboratory
    14. Any of the following abnormal urine tests at screening, confirmed by a second urinalysis 2 weeks later:
    -proteinuria (1+ or greater)
    - haematuria, without known etiology
    - glycosuria, without known etiology
    15. Positive for hepatitis C or current hepatitis B infection
    16. Known to be postive for HIV at screening visit
    17. Blood donation within 2 months prior to Day 0
    18. History of drug or alcohol abuse within 1 year prior to Day 0
    19. Current enrollment in any other study treatment or disease study
    20.Inability to comply with study requirements
    21. Other unspecified reasons that, in the opinion of the investigator or Biogen Idec, make the subject unsuitable for enrollment
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of subjects with ACR20 response at week 12
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 124
    F.4.2.2In the whole clinical trial 150
    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 Decision2009-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-17
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