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    Summary
    EudraCT Number:2004-003771-37
    Sponsor's Protocol Code Number:Hx-CD20-403
    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:2005-11-03
    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 number2004-003771-37
    A.3Full title of the trial
    A double-blind, randomized, placebo controlled, dose escalation, multi-center phase I/II trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with active rheumatoid arthritis who have previously failed one or more disease modifying anti-rheumatic drugs.
    A.3.2Name or abbreviated title of the trial where available
    HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/II
    A.4.1Sponsor's protocol code numberHx-CD20-403
    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 SponsorGenmab A/S
    B.1.3.4CountryDenmark
    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 Information not present in EudraCT
    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 nameHuMax-CD20
    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 INNN/A
    D.3.9.1CAS number 679818-59-8
    D.3.9.2Current sponsor codeHuMax-CD20
    D.3.9.3Other descriptive nameHuman monoclonal antibody directed against CD20 on B-cells
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.8.3Pharmaceutical form of the placeboSolution for infusion
    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
    Active Rheumatoid Arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A: To evaluate the safety of HuMax-CD20 in patients with active rheumatoid arthritis.
    Part B: To evaluate the efficacy of HuMax-CD20 in patients with active rheumatoid arthritis using the American College of Rheumatology (ACR) Response Assessment and Disease Activity Score (DAS) at 12 to 24 weeks after initiation of treatment.
    E.2.2Secondary objectives of the trial
    Part A and B:
    To evaluate the efficacy of HuMax-CD20 in patients with active rheumatoid arthritis by measuring the degree and duration of B-cell depletion

    To determine the pharmacokinetic profile of HuMax-CD20 in patients with active rheumatoid arthritis

    To determine host immune response, Human Anti Human Antibodies (HAHA), against HuMax-CD20

    Part B:
    To evaluate the safety of HuMax-CD20 in patients with active rheumatoid arthritis.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1) Males and females ≥ 18 years
    2) A diagnosis of rheumatoid arthritis according to the American College of Rheumatology (ACR) of at least six months duration
    3) Active disease at the time of screening as defined by :
    - Six or more swollen joins (of 28 joints)
    and
    - Six or more tender joints (of 28 joints)
    and
    - Erythrocyte Sedimentation Rate (ESR) ≥ 22 mm/h (using Becton Dickinson Seditainer) and/or C-Reactive Protein (CRP) ≥ 10 mg/L (1 mg/dL)
    4) RA functional class I, II, or III
    5) Treatment failure to one or more DMARDs.
    - Treatment failure is defined as either intolerance at any time or insufficient efficacy after a minimum of 12 weeks of DMARD treatment.
    - DMARDs include, among others, methotrexate, hydroxychloroquine, chloroquine, gold preparations, azathioprine, D-penicillamine, sulfasalazine, minocycline, leflunomide, and cyclosporine A.
    6) Applicable only to patients on methotrexate therapy at time of screening: Treatment with methotrexate for at least 12 weeks prior to planned start of trial treatment (Visit 2), with possible interruption of treatment of maximum two weeks in total, in the period 5-12 weeks from Visit 2.
    7) Applicable only to patients on methotrexate therapy at time of screening: Treatment with a stable dose of methotrexate (7.5 – 25 mg/week, p.o., i.m., and/or s.c.) for at least four weeks prior to planned start of trial treatment (Visit 2)
    E.4Principal exclusion criteria
    1) Use of DMARDs (other than methotrexate, if patient is on methotrexate treatment at time of screening): ≤ 4 weeks prior to planned start of trial treatment (Visit 2).If patient is not on methotrexate treatment at time of screening: Methotrexate ≤ 4 weeks prior to planned start of trial treatment (Visit 2). Specifically for leflunomide treatment: Use of leflunomide ≤12 weeks prior to planned start of trial treatment (visit 2) unless the patient has completed peroral cholestyramine treatment for washout, according to locally accepted clinical practices.
    2) Exposure to other biological products (e.g. etanercept, infliximab, adalimumab, and kineret) within 4 weeks prior to planned start of trial treament (Visit 2), and/or exposure to anti-CD20 antibodies within two years before screening for this trial
    3) Any use of cyclophosphamide, nitrogen mustard, chlorambucil or other alkylating agents within five years before screening for this trial
    4) Within four weeks prior to planned start of trial treatment (Visit 2):
    - Treatment with oral corticosteroids ( > 10 mg prednisolone per day or equivalent)
    - Start of oral corticosteroid treatment
    - Change in any ongoing oral corticosteroid dose
    5) Use of intra-articular, i.m. or i.v. corticosteroids (including i.m. adrenocorticotrophe hormone) within four weeks prior to planned start of trial treatment (Visit 2)
    6) Active autoimmune disease (other than RA and RA-associated secondary diseases) requiring immunosuppressive therapy
    7) Diagnosis of fibromyalgia or other chronic pain syndrome requiring daily narcotic treatment
    8) Past or current malignancy, except for
    - Resected cervical carcinoma Stage 1B or less
    - Resected non-invasive basal cell and squamous cell skin carcinoma
    - Malignant melanoma with a complete response of a duration of > 10 years
    - Other cancer diagnoses with a complete response of a duration of > 5 years
    9) Chronic or current infectious disease such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, sinusitis, and tuberculosis
    10) History of infected joint prosthesis within five years before Visit 1 and infected native joints within one year before Visit 1
    11) Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from Visit 1, congestive heart failure, 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 or psychiatric disease
    13) History of significant cerebrovascular disease
    14) Screening laboratory values:
    - Hemoglobin < 6.2 mmol/L (9.9 g/dL)
    - Neutrophils < 2 x 109/ L
    - Platelets < 100 x 109/ L
    - S-ALAT > 1.5 times the upper limit of normal
    - S-ALP > two times the upper limit of normal
    - S-creatinine > 133 µmol/L (1.5 mg/dL)
    15) Known or suspected positive serology for HIV
    16) Positive serology for hepatitis B or C
    17) Patients previously screened for this trial, unless reason for previous screen failure was failure to fulfill inclusion criterion no. 3
    18) Current or previous (within four weeks of screening) participation in any other clinical trial
    19) Patients known or suspected to be unable to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
    20) Breast feeding women or women with a positive pregnancy test at screening
    21) Women of childbearing potential not willing to use adequate contraception during the trial. Adequate contraception is defined as hormonal birth control or intrauterine device. For patients in the USA the use of a double barrier method is also considered adequate.
    E.5 End points
    E.5.1Primary end point(s)
    Part A: Adverse Events.
    Part B: ACR20
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Dose escalation
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    The trial ends, when the last patient has completed week 24. Please see the protocol.
    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 months9
    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 months9
    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 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 2005-11-03. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 230
    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 Decision2006-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-04-04
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