Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2008-006936-37
    Sponsor's Protocol Code Number:3199K1-2001-WW
    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:2009-04-16
    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 number2008-006936-37
    A.3Full title of the trial
    A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate
    A.4.1Sponsor's protocol code number3199K1-2001-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 Pharmaceuticals Inc., acting through its division Wyeth Research, a Pfizer company
    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.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 nameILV-094
    D.3.2Product code ILV-094
    D.3.4Pharmaceutical form Powder 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 codeILV-094
    D.3.9.3Other descriptive nameRecombinant human anti IL-22 monoclonal antibody IgG1
    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.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 typeRecombinant human anti IL-22 monoclonal antibody IgG1
    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 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 (RA)
    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
    To assess the safety and efficacy of different dose regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with active Rheumatoid Arthritis on a background of methotrexate.
    E.2.2Secondary objectives of the trial
    To assess the pharmacokinetic (PK), pharmacodynamic (PD), immunogenicity profile and subject-reported outcomes.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Pharmacogenetic sub-study: Genotypes from whole blood samples may be measured and analyzed for markers associated with rheumatoid arthritis and response to ILV-094 administration.
    Optional Pharmacogenomic sub-study: RNA from whole blood samples collected during the study may be measured and analyzed for markers associated with rheumatoid arthritis and response to ILV-094 administration.
    E.3Principal inclusion criteria
    1. Male or or female aged 18 years or older at the time of signing the ICF (or older as required by local regulation or ethics committees).
    2. All male and female subjects who are biologically capable of having children must agree and commit to the use of a highly effective method of birth control for the duration of the study and for 12 weeks after the last dose of test article. A subject is still biologically capable of having children if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.
    3. Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of RA for at least 6 months prior to screening.
    4. ACR functional class I through III.
    5. Active RA at the time of screening and baseline consisting of ≥ 5 swollen and ≥ 5 tender joints (28-joint count) and at least 1 of the following at screening:
    a. C-reactive protein (CRP) ≥ 10 mg /L.
    b. Erythrocyte sedimentation rate (ESR) (as measured by the Westergren method) ≥ 28 mm/h.
    6. Must be receiving methotrexate for at least 12 weeks, with stable route and dose (up to 25 mg weekly according to standard medical practice and local regulation) for at least 8 weeks prior to the baseline visit.
    7. Negative urine pregnancy test result for all women.
    E.4Principal exclusion criteria
    1. Any major illness/condition or evidence of unstable clinical condition (eg, cardiovascular, cerebrovascular, neurologic, metabolic, immunologic, infectious, hepatic, or renal condition; uncontrolled diabetes mellitus; or hypertension) or any serious disorder (eg, current or history of alcohol or drug abuse, current or history of psychiatric disease) that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in and completion of the study, or could preclude the evaluation of the subject’s response, or interfere with the subject’s ability to give informed consent.
    2. Pregnant or breastfeeding women or women planning to become preganant during the study. A urine pregnancy test must be performed during the screening and baseline visits for all women.
    3. Subjects with other rheumatic diseases, including but not limited to Lyme disease, psoriatic arthritis, spondyloarthropathy, systemic lupus erythematosus, systemic vasculitis, polymyositis, infectious or reactive arthritis, overlap syndrome, scleroderma, Reiter syndrome, or primary Sjögren syndrome.
    4. Cancer or history of cancer (other than adequately treated cutaneous basal cell carcinoma and squamous cell carcinoma of the skin or in situ cervical cancer, with no evidence of recurrence).
    5. Contraindications for treatment with methotrexate.
    6. Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C antibodies (HCV).
    7. History of drug-induced liver injury, liver cirrhosis, or fibrosis at any time before the baseline visit.
    8. Laboratory abnormalities at screening including the following:
    a. Hemoglobin < 8.5 g/dL (SI units: < 85 g/L)
    b. White blood cell (WBC) count < 3.50 x 103/mm3 (SI units: < 3.50 x 109/L)
    c. Platelets < 110,000/mm3 or ≥ 1,000,000/mm3 (SI units: < 110 x 109/L or ≥ 1,000 x 109/L)
    d. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 x the upper limit of normal (ULN)
    e. Serum creatinine > 2 mg/dL (SI units: > 177 μmol/L)
    9. Other clinically significant laboratory, electrocardiogram (ECG), or vital sign abnormalities at screening.
    10. Active tuberculosis or history of tuberculosis. Subjects with latent tuberculosis are allowed if there is documentation of completion of a course of chemoprophylaxis per country-specific medical guidelines. A tuberculosis test, interpreted by the investigator according to local standards or country specific-guidelines, must be performed during the screening visit for subjects with no documentation of tuberculosis test results available within 4 weeks before the baseline visit.
    11. Clinically significant finding on chest radiograph within 3 months before the baseline visit. A chest X ray must be obtained during the screening visit for subjects with no documentation of chest X ray results available within 3 months before baseline.
    12. Known or suspected allergy or intolerance to any components of test article (refer to the investigator’s brochure), or other compounds related to these classes of medication.
    13. Known hypersensitivity reaction to medicine, including biopharmaceutical proteins.
    14. Any prior use of B cell-depleting therapy.
    15. Receipt within 24 weeks before the baseline visit:
    • any investigational biological drugs not listed under the other exclusion criteria
    • any cytotoxic agents, including cyclophosphamide (cytoxan), or chlorambucil
    • intravenous immunoglobulin (IVIG)
    • Prosorba column (extracorporeal immunoadsorption protein A column)
    16. Receipt within 12 weeks before the baseline visit:
    • any investigational drugs (other than investigational biological drugs and those not listed under the other exclusion criteria) or devices
    • any disease-modifying antirheumatic drugs (DMARDs) (including biological drugs), other than methotrexate, or immunosuppressive drugs not listed under the other exclusion criteria.
    • any surgical joint interventions (open or arthroscopic)
    17. Receipt within 8 weeks before the baseline visit:
    • abatacept, adalimumab, or infliximab
    18. Receipt within 4 weeks before the baseline visit:
    • etanercept, hydroxychloroquine, or sulfasalazine
    • intra-articular hyaluronic acid injections
    • any live (attenuated) vaccine
    • change in the dose of folic or folinic acid
    19. Receipt within 2 weeks before the baseline visit:
    • more than 10 mg/day of oral prednisone or equivalent, or a change in the dose of prednisone or its equivalent, or having intra-articular corticosteroid injection or bolus intramuscular (IM) or IV treatment with corticosteroids (≥ 20 mg prednisone or equivalent)
    • more than 1 nonsteroidal anti-inflammatory drug (NSAID), or a change in the dose of the NSAID, or an NSAID dose greater than the maximum recommended dose (Aspirin at doses up to 325 mg for cardiac protection daily is permitted.)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be ACR20 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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, subject-reported outcomes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    The end of the study is the last visit of the last subject.
    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 months18
    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 months18
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Witness required if the subject is unable to read (blind, illiterate)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 180
    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)
    It is assumed that after a subject ends participation in the trial the local standard of care will apply.
    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 Decision2009-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 10:44:06 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA