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    Summary
    EudraCT Number:2005-000095-41
    Sponsor's Protocol Code Number:M03-658
    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:2005-04-12
    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 number2005-000095-41
    A.3Full title of the trial
    A Multi-Centre Open-Label Continuation Study in Moderate to Severe Chronic Plaque Psoriasis Subjects who Completed a Preceding Psoriasis Clinical Study with Adalimumab
    A.3.2Name or abbreviated title of the trial where available
    Not available
    A.4.1Sponsor's protocol code numberM03-658
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot available
    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 Yes
    D.2.1.1.1Trade name Adalimumab
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.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
    Severe Chronic Plaque Psoriasis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    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 long term safety, tolerability and clinical efficacy of adalimumab in subjects with moderate to severe chronic plaque psoriasis entering from prior adalimumab psoriasis studies as well as examine the effectiveness of adalimumab retreatment following withdrawal from therapy and subsequent relapse (PGA >= 3) of psoriasis. Please refer to sections 5.3.2 and 5.3.3 of the study protocol for a detailed description of the study parameters.
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Psoriasis subjects with a PASI >50 at final visit for M02-529 or M03-596
    2. Subjects who relapse after Week 24 in M02-538
    3. Phase 3 subjects who meet the entry criteria specified in their preceeding Ph 3 protocol
    4. Subjects over 18 years of age
    5. If female subject is either not of childbearing poteintial, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tual ligation, bilateral oophorectomy or hysterectomy) or is of child-bearing potential and practising one of the following methods of birth-control throughout the study and for 150 days after the last dose of study drug:
    - condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
    - contraceptives (oral or parenteral) for three months prior to study drug administration)
    - a vasecromized partner
    6. If female of childbearing potential, results of the urine pregnancy test conducted at the last visit of the previous adalimumab study is negative or a serum pregnancy test is negative.
    7. Subject is judged to be in generally good health as determined by the principal investigator based upon the results of laboratory evaluations and physical examinations done throughout the preceding psoriasis sstudy with adalimumab.
    8. Subjects must be able and willing to gie written informed consent and comply with the requirements of this study protocol.
    9. Subjects must be able to self-inject study medication or have a designee who can inject the study medication.
    E.4Principal exclusion criteria
    1. The following subjects in a preceding psoriasis study with adalimumab are not eligible for enrollment in M03-658: a) M02-538 subjects who prematurely discontinue for reasons other than relapse b) M02-529 and M03-596 subjects who had a < PASI 50 at the final study visit c) subjects who complete the M02-538 360 day follow-up visit, and d) subjects who do not meet the requirements for entering M03-658 specified in their phase 3 protocol
    2. For any reason, the subject is considered by the investigator to be an unsuitable candidate for continuing therapy in the M03-658 study
    3. Subject has abnormal laboratory or other test values, that in the opinion of the investigator, would make it unsuitable for the subject to participate in this study.
    4. Subject has other active skin diseases that may interfere with evaluation of psoriasis
    5. Subject has a history of an allergic reaction or significant sensitivity to constituents of study drug (see Table 3) including latex (a component of the syringe)
    6. Subject must use topical therapies for the treatment of psoriasis such as corticosteroids, vitamin D analogs, or retinoids during the study. Subjects are allowed to use
    - Medicated shampoos that do not contain corticosteroids (i.e., shampoos containing tar, salicylic acid, or anthralin),
    - Bland (without beta, i.e. salicylic acid, or alpha hydroxy acids) emollients
    - low potency (calss VI or Vii) topical corticosteroids on the palms, soles, face, inframmatory area and groin only. See appendix K for a listing of examples of Class VI or VII topical corticosteroids
    7. Subject cannot avoid UVB or UVA phototherapy, including PUVA, during the study
    8. Subject cannot avoid excessive sun exposure or the use of tanning booths during the study
    9. Subject may require systemic therapy known to improve psoriasis, other than study drug, during the trial
    10. Subject has a poorly controlled medical condition, including unstable cardiovascular disease, recent stroke (within 3 months), advanced or poorly controlled diabetes, or documented history of recurrent infections
    11. Subject has any underlying cardiac, pulmonary, metabolic, renal, or gastrointestinal condition, which in the opinion of the investigator, would make it unsuitable for the subject to participate in the study
    12. History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease
    13. History of cancer or 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
    14. Subject has a history of active TB or listeriosis, or ongoing chronic or active infections requiring hospitalization or chronic use of an anti-infective agent
    15. Use or planned use of anti-retroviral therapy at any time during the study
    16. Subject is known to have immune deficiency or is immunocompromised
    17. Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study
    18. Subject has a history of clinically significant drug or alcohol abuse in the last year
    19. Subject has erythrodermic psoriasis or generalized pustular psoriasis
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy variables in Period O:
    1. Proportion of subjects achieving PGA of 'clear' or 'minimal' at each visit.
    2. Proportion of subjects achieving PASI 50/75/90/100 at each visit.
    Efficacy variables in Period W:
    1. Proportion of subjects experiencing relapse (PGA >= 3) during Period W.
    2. Time to relapse.
    3. Time to loss of PGA 'clear' or 'minimal'.
    4. Proportion of subjects achieving PGA of 'clear' or 'minimal' at each visit.
    5. Proportion of subjects achieving PASI 50/75/90/100 at each visit.
    6. Change and percent change from Week 0W in FACIT-Fatigue Scale at each visit.
    7. Change from baseline Week 0W in DLQI at each visit.
    8. Proportion of subjects with DLQI=0 at each visit.
    Efficacy variables in Period R:
    1. Proportion of subjects regaining PGA of 'clear' or 'minimal' at each visit.
    2. Proportion of subjects achieving PASI 50/75/90/100 at each visit.
    3. Time to regain of PGA 'clear' or 'minimal'.
    4. Change and percent change from Week 0W and from Week 0R in FACIT-Fatigue
    Scale at each visit.
    5. Change from Week 0W and from Week 0R in DLQI at each visit.
    6. Proportion of subjects with DLQI=0 at each visit.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years5
    E.8.9.2In all countries concerned by the trial months4
    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 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 165
    F.4.2.2In the whole clinical trial 1500
    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)
    Treatment and care after participation will not be different from expected normal treatment.
    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 Decision2005-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-05-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-10-20
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