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    Summary
    EudraCT Number:2007-002951-18
    Sponsor's Protocol Code Number:GEN411/OFA110634
    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:2008-06-30
    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 number2007-002951-18
    A.3Full title of the trial
    A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-α antagonist therapy
    A.3.2Name or abbreviated title of the trial where available
    Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-α antagonist
    A.4.1Sponsor's protocol code numberGEN411/OFA110634
    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 SponsorGlaxoSmithKline Research & Development
    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 nameOfatumumab
    D.3.2Product code HuMax-CD20
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOfatumumab
    D.3.9.1CAS number 679 818-59-8
    D.3.9.2Current sponsor codeHuMax-CD20
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 typeHuman monoclonal antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.4Route of administration of the placeboIntravenous 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 13.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate efficacy of ofatumumab in reducing clinical signs and symptoms in adult RA patients after a single course of ofatumumab
    E.2.2Secondary objectives of the trial
    1) To evaluate long-term efficacy of repeated courses of ofatumumab
    2) To evaluate the effect on established and novel biomarkers of clinical response after single and repeated courses of ofatumumab
    3) To evaluate ofatumumab with respect to impact on patient reported outcomes after single and repeated courses of ofatumumab
    4) To evaluate the risk of host immune response against ofatumumab after single and repeated courses of ofatumumab
    5) To evaluate the safety of ofatumumab after single and repeated courses of ofatumumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age ≥ 18 years
    2) A diagnosis of rheumatoid arthritis according to the American College of Rheumatology (ACR1987 classification) of at least six months’ duration from diagnosis at screening
    3) Active disease at the time of screening as defined by:
    ≥ 8 swollen joints (of 66 joints assessed)
    and
    ≥ 8 tender joints (of 68 joints assessed)
    and
    C-Reactive Protein (CRP) ≥ 1.0 mg/dL or Erythrocyte Sedimentation Rate (ESR) ≥ 22 mm/hour
    and
    DAS28≥3.2 (based on ESR)
    Note: The swollen and tender joints must be reassessed at baseline (Visit 2) to ensure these eligibility criteria are fulfilled prior to randomization. Where possible joint count reassessment must be performed at the baseline visit (Visit 2); if this is not possible it can be performed ≤ 3 days prior to Visit 2.
    4) RA functional class I, II or III
    5) Inadequate response to previous or current TNF-α antagonist treatment after infliximab therapy (≥3 mg/kg; at least 4 infusions), or adalimumab therapy (40 mg at minimum of every other week for ≥3 months), or etanercept therapy (25 mg twice weekly or 50 mg once a week for ≥3 months) defined as:
    Inadequate efficacy according to the investigator’s judgment
    and/or
    Intolerance defined as one or more side effects following at least one administration of one of the TNF-α antagonists at the dose listed above that reasonably results in the discontinuation of treatment with the TNF-α antagonist treatment
    6) Treatment with methotrexate (MTX), 7.5-25 mg/week, for at least 12 weeks and at a stable dose for at least 4 weeks prior to Visit 2. Doses of MTX as low as 7.5 mg per week are permitted for patients who can not tolerate higher doses
    7) Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity including wash-out of other drug products is carried out
    France: In France, a patient will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
    E.4Principal exclusion criteria
    1) Patients with a history of a rheumatic autoimmune disease other than RA (except secondary Sjögren's syndrome) or with significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis or Felty's syndrome)
    2) Previous exposure to biologic anti-rheumatic therapies (with exceptions specified in (3)), including investigational compounds (e.g. anti-CD11a, anti-CD19, anti-CD20, anti-CD22, anti-BLyS/BAFF, anti-CD3, anti-CD4, anti-CD5, CAMPATH, and anti-IL6 receptor)
    3) Exposure to etanercept ≤ 4 weeks, infliximab or adalimumab ≤ 8 weeks, or abatacept ≤ 12 weeks prior to Visit 2
    4) Received any of the following treatments within 4 weeks prior to Visit 2:
    - Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues, monoclonal antibodies)
    - Glucocorticoid unless given in doses equivalent to ≤ 10 mg of prednisolone /day
    - Intra-articular, i.m. or i.v. corticosteorids
    - Live/attenuated vaccinations
    - Cyclosporine
    - Azathioprine
    - Penicillamine
    - Bucillamine
    - Chloroquine
    - Hydroxychloroquine
    Sulfasalzine
    5) Exposure to leflunomide within 12 weeks prior to Visit 2 unless the patient has completed peroral cholestyramine treatment for washout according to manufacturer's instructions and locally accepted clinical practices
    6) Exposure to gold therapy ≤ 12 weeks prior to Visit 2
    7) Exposure to i.v. immunogammaglobulins ≤ 24 weeks prior to Visit 2
    8) Past or current malignant melanoma
    9) Past or current malignancy, except for:
    - Cervical carcinoma Stage 1B or less
    - Non-invasive basal cell and squamous cell skin carcinoma
    - Other cancer with complete response duration of > 5 years
    10) Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis B and C
    Note 1) Subjects with screening X-ray suggesting of TB without adequate TB treatment documented should be excluded 2) Subjects with positive skin tuberculin test should excluded if judged at risk of latent TB infection.
    11) Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from screening, congestive heart failure, known QT abnormalities, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
    12) Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral psychiatric disease, or evidence of demyelinating disease
    13) History of significant cerebrovascular disease
    14) Known HIV positive
    15) Screening laboratory values (according to central laboratory):
    - Hemoglobin < 5.6 mmol/L (9.0 g/dL)
    - Neutrophils < 2 x 109/ L
    - Platelets < 100 x 109/ L
    - Serum IgG < lower limit of normal
    - S-ALAT > 3.0 times the upper limit of normal
    - S-AST > 1.5 times the upper limit of normal
    - S-ALP > 2 times the upper limit of normal
    - S-creatinine > 133 µmol/L (1.5 mg/dL)
    16) Positive serology for hepatitis B (HB) defined in terms of HBsAg, anti-HBc and anti-HBs antibodies.
    - Patients positive for HBsAg should be excluded
    - Patients negative for HBsAg and anti-HBs antibody, but positive for anti-HBc antibody should be teted for HB DNA and if positive excluded.
    Patients with documented vaccination against Hepatitis B (primary and secondary immunization and booster) will be considered negative
    17) Positive for Hep C antibody and positive or indeterminant Hep C RIBA immunoblot assay
    18) Positive plasma / white cell JC Virus (JCV) PCR (either compartment)
    19) Known hypersensitivity to components of the investigational medicinal product
    20) Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to screening
    21) Current participation in any other interventional clinical study
    22) Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
    23) Breast feeding women or women with a positive pregnancy test at screening
    24) Women of childbearing potential not willing to use adequate contraception during study and one year after last dose of ofatumumab. Adequate contraception is defined as abstinence, oral hormonal birth control, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partner sterilization if male partner is sole partner for that patient.
    25) Males with female partner of child bearing potential not willing to use condom or abstinence for duration of study. Contraceptive measures should only be discontinued after completion of or withdrawal from the study following advice of the physician prescribing methotrexate and in accordance with the local methotrexate label.
    E.5 End points
    E.5.1Primary end point(s)
    ACR20 at 24 weeks
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Initial double blind period: randomised, double-blind, parallel group. Extension period: open label
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    End of trial will be LPLV in follow-up phase. With amendment 5 patients in Open-label will enter the Follow-Up at the next visit and will be followed every 12 weeks until B-cells and IgG return to normal or baseline levels, or for a maximum of 2 years from the last scheduled visit in the Open-laabel, whichever occurs earlier. The CSR include data through the premature study end of the Openlabel Period. An addendum will be prepared once all patients have completed the follow up period.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months2
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 165
    F.4.2.2In the whole clinical trial 236
    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 Decision2008-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-16
    P. End of Trial
    P.End of Trial StatusCompleted
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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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