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    Summary
    EudraCT Number:2006-003146-41
    Sponsor's Protocol Code Number:50021031-2
    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:2006-11-23
    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 number2006-003146-41
    A.3Full title of the trial
    A CONTROLLED RANDOMIZED DOUBLE-BLIND MULTICENTER STUDY COMPARING TWO THERAPY STRATEGIES IN DMARD-NAIVE EARLY RHEUMATOID ARTHRITIS PATIENTS OVER 48 WEEKS: INDUCTION THERAPY WITH ADALIMUMAB AND METHOTREXATE OVER 24 WEEKS FOLLOWED BY METHOTREXATE MONOTHERAPY UP TO WEEK 48 VS. METHOTREXATE MONOTHERAPY
    A.3.2Name or abbreviated title of the trial where available
    HIT HARD
    A.4.1Sponsor's protocol code number50021031-2
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number36745608
    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 SponsorCharité-Universitätsmedizin Berlin; Department of Rheumatology and Clinical Immunology
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott laboratories Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameHUMIRA
    D.3.4Pharmaceutical form 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 INNAdalimumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Metex
    D.2.1.1.2Name of the Marketing Authorisation holderMethotrexate
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameMetex
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 Yes
    D.3.11.13.1Other medicinal product typefolic acid antagonist
    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 placeboInjection*
    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
    Musculoskeletal disorders
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10048592
    E.1.2Term Musculoskeletal disorder
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of an induction therapy over 24 weeks with subsequent
    MTX therapy to MTX alone over 48 weeks in subjects with active early RA.
    Efficacy is primary measured with the DAS 28 at week 48.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    - To evaluate DAS 28 at week 24,
    - The partial-remission (DAS 28 < 2,6) at week 24 and 48,
    - The duration of clinical remission during the trial,
    - The variables of the WHO/ILAR core set for clinical trials (DAS 28, HAQ),
    - To evaluate ACR 20,ACR 50, ACR 70 from baseline to week 24,
    - To evaluate ACR 20,ACR 50, ACR 70 from baseline to week 48,
    - The change in ACR 20,ACR 50, ACR 70 response between from week 24 to week 48,
    - The radiographic change (x - ray of hands and feet in 2 dimensions) from baseline to week 48 by central assessment by the modifyed Sharp-Score and Ratingen Score,
    - descriptive analysis of change Glucocorticoid, NSAIDs/Coxib dosage,
    - Report on adverse events and serious adverse events (referring to ICH GCP/CPMP ICH E2).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient must meet all of the following inclusion criteria to be enrolled into this study:
    - Patients with definite RA referring to the ACR Classification Criteria of 1987 up to 1 year after first RA symptoms
    - Age 18 to 70 years
    - Has active disease at the time of randomization as indicated by 6 from 68 tender and 6 from 66 swollen joints and at least one of the following two criteria: Westergren erythrocyte sedimentation rate (ESR) ¸ 28 mm/hour od C-reactive protein (CRP) levels > 1.0 mg/dl.
    - Has morning stiffness > 30 min.
    - No current or prior therapy with DMARDs or biologics.
    - NSAIDs and corticosteroids treatment has to be stable 2 weeks prior to
    screening and during the trial with maximal · 10 mg/d prednisoloneequivalent.
    - Is capable of understanding and signing an informed consent form
    - Is able and willing to self-inject study drug or have a designee who can do so
    - Is able and willing to take oral medication
    - Is able to store injectable test article at 2± C to 8± C
    - Sexually active women participating in the study must use a medically acceptable form of contraception for women. This includes oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.
    E.4Principal exclusion criteria
    Patients meeting any following exclusion criteria are not to be enrolled in
    this study:
    - Has significant concurrent medical diseases including cancer or a history of cancer (other than resected cutaneous basal and squamous cell carcinoma, in situ cervical cancer) in the last 5 years
    - Has uncompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease, or history of human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, other rheumatologic diseases than RA, or central nervous systems demyelinating events suggestive or multiple sclerosis
    - Received anti-CD4, diphtheria interleukin-2 fusion protein, antiinterleukin- 6, rituximab or other immunsuppressive biologic before screening, and treatment with such agents if there are persistent signs of immunosuppression (with a subsequent abnormal absolute T-cell count) at screening count.
    - Received any live (attenuated) vaccines within 4 weeks of screening visit.
    - Received intra-articular corticosteroid injection within 4 weeks of screening.
    - Received bolus intramuscular/intravenous treatment with corticosteroids (>10 mg prednisone or equivalent) within 4 weeks of screening visit
    - Is taking > 10 mg/d prednisone or equivalent
    - Has a history of confirmed blood dyscrasias
    - Has a significant active infection or any underlying diseases that could predispose subjects to infections (e.g. history of recurring infections, leg ulcers, advanced or poorly controlled diabetes)
    - Has active infection with Hep A, B, C virus, tuberculosis, chronic infections, latent tuberculosis (has to be excluded by Chest x-ray and PPD-Test according to Mendel-Mantoux); In case of latent tuberculosis isoniazid 300 mg for 10 months, starting 1 month prior to treatment is obligatory
    - Has renal disease (creatine level > 175 ¹mol/L) or a history of known liver cirrhosis, fibrosis
    - Has an abnormal liver function (AST, GGT, ALT ¸ 2 x upper limit of normal)
    - Has a history of psychiatric disease that would interfere with the ability to comply with the study protocol.
    - Is pregnant or breast-feeding
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the DAS 28 score at week 48.
    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 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 concerned18
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    The patient remains on the trial as long as it is of its his/her best interest. Patients without progressive disease and without sings of unacceptable toxicity will receive study treatment for at 48 weeks. Thereafter, treatment can be continued until progression or occurrence of unacceptable toxicities at the discretion of the treating physician and acceptability to the patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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 state250
    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)
    The treatment after the subject has ended his/her participatient in the trial is the standard of medical treatment in rheumatology with DMARD as mono- or combination therapy.
    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 Decision2006-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-04-28
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