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    The EU Clinical Trials Register currently displays   35898   clinical trials with a EudraCT protocol, of which   5892   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-004826-21
    Sponsor's Protocol Code Number:M05-760
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-01-20
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-004826-21
    A.3Full title of the trial
    Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors.
    A.3.2Name or abbreviated title of the trial where available
    RHAPSODY
    A.4.1Sponsor's protocol code numberM05-760
    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 SponsorAbbott GmbH & Co. KG
    B.1.3.4CountryGermany
    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 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 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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Ankylosing Spondylitis
    MedDRA Classification
    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 adalimumab 40 mg eow sc in subjects with active AS in day-to-day clinical practice. The safety and efficacy of adalimumab will be analyzed based on concomitant NSAID use, concomitant steroid use, concomitant DMARD use, and prior exposure to other TNF inhibitors (etanercept, infliximab). The safety and efficacy of adalimumab in subjects with AS will be evaluated based on the type of clinical presentation of the disease (axial, peripheral arthritis, and /or enthesitis). The number of subjects with total ankylosis of the spine was limited in previous phase 3 studies of adalimumab in AS, thus, limited experience is available for use of adalimumab in subjects with advanced, including total ankylosis of the spine. This study will allow for further analyses of safety and efficacy in subjects with advanced spinal ankylosis. The safety and efficacy profile will also be evaluated by AS associated disorders including inflammatory bowel disease, psoriasis and uveitis.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    A subject will be eligible for study participation if he/she meets all of the following
    criteria:
    1. Able and willing to give written informed consent and to comply with the
    requirements of the study protocol.
    2. Males and females 18 years of age or older.
    3. Diagnosis of AS according to the modified New York Criteria for Ankylosing
    Spondylitis 1984.
    4. Documented active AS based on the opinion of a physician for at least 3 months.
    5. Active AS with BASDAI ≥ 4 at the Screening Visit.
    6. Unsatisfactory response to standard AS therapies in accordance with the current
    national guidelines for treatment of AS with TNF inhibitors (if applicable)
    including a minimum of failing at least one NSAID. National guidelines (if
    applicable) must be followed if the guidelines are more strict regarding the use of
    TNF inhibitors for the treatment of AS.
    7. Use of reliable method of contraception, e.g., IUDs, condoms, or hormone (oral,
    implantable, or injectable) contraceptives by all female subjects of childbearing
    potential. Subject must follow the manufacture’s recommendations of
    contraception prior to the administration of study drug and through 150 days
    following the last administration of adalimumab.
    8. Able and willing to self-administer sc injections or have available a suitable person
    to administer sc injections.
    9. A negative pregnancy test (serum HCG) for women of childbearing potential prior
    to start of study treatment.
    10. Subject must be evaluated for active and latent TB infection by using a PPD skin
    test, T SPOT-TB test, chest x-ray and a detailed review of the subject's medical
    history. Guidelines regarding the treatment of latent TB must be followed prior to
    the administration of adalimumab.
    E.4Principal exclusion criteria
    A subject will be excluded from the study if he/she meets any of the following criteria:
    1. Prior treatment with any investigational agent within 30 days, or five half-lives of
    the product, which ever is longer.
    2. Treatment within the last two months with infliximab or within the last three
    weeks with etanercept or previous treatment at any time with adalimumab.
    3. Known allergy to excipients of adalimumab formulation.
    4. History of or current acute inflammatory joint disease of origin other than AS, e.g.,
    rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus etc.
    5. Treatment with corticosteroids (prednisolone equivalents) under the following
    conditions:
    ● Dose is >10 mg/d systemically within the 28 days before screening.
    ● Intraarticular injections or infiltrations of peripheral joints and tendons within
    28 days before or at screening.
    ● Intraarticular injections of sacraliliac joints without therapeutic response <14
    days before screening.
    6. Other medical conditions: uncontrolled diabetes, unstable ischemic heart disease,
    congestive heart failure (NYHA III-IV), recent stroke (within three months),
    chronic leg ulcer and any other condition (e.g., indwelling urinary catheter) which,
    in the opinion of the investigator, would put the subject at risk by participation in
    the study.
    7. History of cancer or malignant lymphoproliferative disease other than a
    successfully treated non-metastatic cutaneous squamous cell or basal cell
    carcinoma and/or localized carcinoma in situ of the cervix.
    8. History of positive serology for hepatitis B indicating active infection or history of
    positive serology for hepatitis C.
    9. History of positive HIV status.
    10. Persistent or recurrent infections or severe infections requiring hospitalization or
    treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior
    to enrollment.
    11. Previous diagnosis or signs highly indicative of central nervous system
    demyelinating diseases (e.g., optic neuritis, ataxia, apraxia).
    12. History of active tuberculosis, histoplasmosis or listeriosis.
    13. Female subjects who are pregnant or breast-feeding.
    14. History of clinically significant drug or alcohol abuse in the last year.
    E.5 End points
    E.5.1Primary end point(s)
    Not Applicable
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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 end-of-study is defined as the date of the last subject's last scheduled visit or the actual date of follow-up contact, whichever is longer.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    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 2006-01-20. 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1150
    F.4.2.2In the whole clinical trial 1200
    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 Decision2007-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-02
    P. End of Trial
    P.End of Trial StatusCompleted
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