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    The EU Clinical Trials Register currently displays   39243   clinical trials with a EudraCT protocol, of which   6428   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2008-007185-33
    Sponsor's Protocol Code Number:3242K1-2000-WW
    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:2009-09-09
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2008-007185-33
    A.3Full title of the trial
    A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103
    Administered to Subjects With Active Rheumatoid Arthritis on a Background of
    A.4.1Sponsor's protocol code number3242K1-2000-WW
    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 SponsorWyeth Research Division of Wyeth Pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    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.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 nameATN-103
    D.3.2Product code ATN-103
    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.3.9.2Current sponsor codeATN-103
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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. medicinal product typeATN-103 is a humanized, trivalent, bi-specific tumor necrosis factor (TNF)-inhibiting fusion protein.
    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 placeboPowder for solution 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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    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
    To evaluate the safety and clinical efficacy of multiple ascending
    doses (MAD) of ATN-103 administered SC to subjects with active RA compared with placebo.
    E.2.2Secondary objectives of the trial
    To assess the tolerability, PK, pharmacodynamic (PD), and the
    optimal treatment frequency regimen for ATN-103 (administered every 4 weeks versus every 8 weeks).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Intensive Pharmacokinetics Sampling:
    A full ATN-103 PK profile will be obtained in a subgroup of up to 50 subjects; this is described in the main clinical trial protocol.
    E.3Principal inclusion criteria
    1. Male and female subjects between the ages of ≥ 18 years and ≤ 80 years at the time of signing the ICF.
    2. Meets the American College of Rheumatology (ACR, formerly American Rheumatism
    Association) 1987 revised criteria for classification of RA at least 24 weeks prior to
    3. ACR functional class I to III.
    4. Active RA at the time of screening and at baseline consisting of ≥ 6 swollen and
    ≥ 6 tender joints (28-joint count).
    5. The hs-CRP ≥ 8 mg/L at screening (as determined by blood specimen sent to the Central Lab).
    6. Must be receiving MTX for at least 12 weeks, with a stable dose and route of MTX
    (7.5 - 25 mg weekly) for at least 6 weeks prior to baseline and continuing on that dose for the duration of the study.
    7. The report of a chest radiograph performed within 12 weeks of the screening visit (chest radiograph must be performed during the screening if no prior chest radiograph report is available) documenting the absence of any evidence of malignancy, infection, or abnormalities suggestive of tuberculosis must be obtained and available in the subject’s study file prior to baseline.
    8. All women of childbearing potential (WOCBP) must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at baseline.
     WOCBP are defined as women who are biologically capable of becoming pregnant,
    including women who are using contraceptives or whose sexual partners are either
    sterile or using contraceptives.
     Women of non-childbearing potential (WONCBP) are defined as either
    postmenopausal (history of amenorrhea for ≥ 52 weeks) or who are surgically sterile, such as after hysterectomy, bilateral oophorectomy, or tubal ligation (procedure performed ≥ 52 weeks before screening). This information must be documented in the subject’s source documents.
     WONCBP do not require a serum and urine pregnancy test.
    9. All WOCBP who have sexual intercourse with a non-surgically sterilized male must
    agree and commit to the use of hormone contraception, double barrier contraception, or an intrauterine device for the duration of the study (defined as the time of the signing of the ICF through the conclusion of subject participation). Double-barrier contraception is defined as the use of a diaphragm, suppository, or sponge.
     To be considered surgically sterilized, a male partner must have had a vasectomy at least 24 weeks before study day 1.
    10. All men (unless surgically sterile, as defined above) who have sexual intercourse with a WOCBP must agree and commit to use a medically acceptable form of contraception for the duration of the study (defined as the time of the signing of the ICF through the conclusion of subject participation). Medically acceptable forms of contraception include properly used barrier forms of contraception.
    11. Willingness and ability to participate in all aspects of the study, including SC
    administration of investigational product (by unblinded study personnel), completion of subject assessments, attending scheduled clinic visits, and compliance with all protocol requirements as evidenced by written informed consent.
    E.4Principal exclusion criteria
    1. Pregnant women or nursing mothers.
    2. Presence of active infections, fungal infections, or open cutaneous ulcers, any underlying diseases that could predispose subjects to infections, or history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks of baseline visit.
    3. Significant concurrent, medical conditions at the time of screening or baseline visit
    including, but not limited to:
     Any major illness/condition or evidence of an unstable clinical condition, such as,
    renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, immunologic
    (eg, Felty’s syndrome, human immunodeficiency virus [HIV], infections,
    neurological, cerebral psychiatric disease, or evidence of demyelinating disease
    which, in the investigator’s judgment, will substantially increase the risk associated with the subject developing an adverse event (AE) or serious adverse event (SAE)
    during the study, or preclude the evaluation of the subject’s response.
     A history or current evidence of latent or active tuberculosis infection, evidence of
    prior or currently active tuberculosis by chest radiography, recent close contact with
    an individual with active tuberculosis, or a positive Mantoux tuberculin skin test
    (≥ 5 mm of induration at 48-72 hours without consideration of prior Bacillus
    Calmette-Guérin [BCG] vaccination or as defined by country specific guidelines or
    local standards).
     A history or suspicion (received antibiotics) of a joint prosthesis infection if
    prosthesis not removed or replaced.
     Any rheumatologic disease other than RA, including but not limited to Lyme disease, primary Sjögren’s syndrome, psoriatic arthritis, spondyloarthropathy, systemic lupus erythematosus, systemic vasculitis, polymyositis, infectious arthritis, reactive arthritis (Reiter’s syndrome), or scleroderma.
     Cancer or history of cancer or lymphoproliferative disease within previous 5 years
    (other than resected cutaneous basal cell or squamous cell carcinoma that has been
    treated with no evidence of recurrence).
     Class III or IV congestive heart failure as defined by the New York Heart Association
     Acute coronary syndrome (eg, myocardial infarction, unstable angina pectoris) and
    any history of significant cerebrovascular disease within 24 weeks of screening.
     Have a transplanted organ.
     Documented history of any drug-induced liver injury, liver cirrhosis, or fibrosis at any time before baseline visit.
    4. Abnormality in hematology or biochemistry profiles at screening:
     Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), and hepatitis C antibody (HepCAb) with confirmation by recombinant immuno blot assay (RIBA).
     Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels
    ≥ 2 times the upper limit of normal (ULN).
     Hemoglobin levels ≤ 85 g/L (8.5 g/dL).
     Platelet count ≤ 125 x 10 power 9/L (125,000 cells/mm³) or ≥ 1,000 x 10 power 9/L (1,000,000 cells/ mm³).
     White blood cell count ≤ 3.5 x 10 power 9/L (3,500 cells/ mm³).
     Serum creatinine levels ≥ 177 μmol/L (2 mg/dL).
    5. Any prior use of B cell-depleting therapy.
    6. All drugs which have efficacy in RA (excluding MTX) should be discontinued for
    sufficient time that there is minimal systemic exposure or residual therapeutic activity.
    A comprehensive but not exhaustive list of drugs and the duration they should be discontinued for prior to entering the study is provided in the clinical trial protocol exclusion criteria section.
    7. Known or suspected allergy to ATN-103, any type of TNFi, human immunoglobulin
    proteins or other compounds related to these classes of medication.
    8. Current or history of psychiatric disease, alcohol or drug abuse that, in the opinion of the investigator, would interfere with the ability to comply with the protocol or give informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    ACR20 response at Week 16.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 240
    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)
    Subjects who complete clinical trial 3242K1-2000-WW will be offered participation in an open-label extension study (under a separate protocol) where they will receive ATN-103 regardless of treatment arm cohort assignment in clinical trial 3242K1-2000-WW.
    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 Decision2009-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-01-12
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