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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

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    Summary
    EudraCT Number:2007-002066-35
    Sponsor's Protocol Code Number:A3921035
    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:2007-07-23
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2007-002066-35
    A.3Full title of the trial
    A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THE
    TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS
    A.3.2Name or abbreviated title of the trial where available
    not applicable
    A.4.1Sponsor's protocol code numberA3921035
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbernot applicable
    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 SponsorPfizer Inc, 235 East 42nd Street, New York, NY 10017
    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 nameCP-690,550
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550
    D.3.9.3Other descriptive nameCP-690,550-10
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    D.IMP: 2
    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 nameCP-690,550
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550
    D.3.9.3Other descriptive nameCP-690,550-10
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 No
    D.IMP: 3
    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 Humira® 40 mg solution for injection in pre-filled syringe
    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 nameAdalimumab
    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 INNHumira®
    D.3.9.2Current sponsor codeAdalimumab
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    Rheumatoid Arthritis
    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
    The primary objective is to characterize the dose-response of CP-690-550 over the range of 1-15 mg BID on ACR-20 response criteria at 12 weeks.
    E.2.2Secondary objectives of the trial
    1. To examine the durability of the response of 5 dose levels of oral CP-690,550 (15 mg, 10 mg, 5 mg, 3 mg and 1 mg BID) versus placebo, administered over 6 months for the treatment of the signs and symptoms in subjects with active RA.
    2. To compare the efficacy of adalimumab 40 mg subcutaneous (sc) every other week (QOW), administered over 12 weeks, versus placebo for the treatment of signs and symptoms in subjects with active RA.
    3. To evaluate the safety and tolerability of 5 dose levels of oral CP-690,550 (15 mg, 10 mg, 5 mg, 3 mg and 1 mg BID) administered over 6 months versus placebo to subjects with active RA.
    4. To evaluate the safety of switching from adalimumab to CP-690,550.
    5. To evaluate health status and functional status in these subjects.
    6. To characterize the relationship among doses, plasma concentrations of CP-690,550 and efficacy and safety outcome measures in subjects with active RA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a signed and dated informed consent document(s) indicating that the subject has been informed of all pertinent aspects of the study.
    2. Subjects must be at least 18 years of age.
    3. If the subject is a sexually active woman of childbearing potential, she and any male partner are required to simultaneously use 2 effective contraceptive methods, from the list of effective contraceptives found in Section 4.4
    4. Non-vasectomized men must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception such as an IUD, barrier method with spermicide, oral contraceptive, injectable progesterone, sub-dermal implant, or a tubal ligation, if the woman could become pregnant from the time of the first dose of study medication until completion of follow-up procedures.
    5. The subject has a diagnosis of RA based upon the American College of
    Rheumatology (ACR; formerly American Rheumatism Association) 1987 Revised Criteria5, ie, fulfilling at least 4 of the following 7 criteria for at least 6 consecutive months preceding randomization:
    a. morning stiffness in and around any joint for more than 1 hour;
    b. soft tissue swelling of 3 or more joint areas;
    c. swelling of the proximal interphalangeal (PIP), metacarpophalangeal (MCP) or wrist joints;
    d. symmetrical joint swelling;
    e. rheumatoid nodules;
    f. serum rheumatoid factor positive;
    g. radiographic erosions and/or periarticular osteopenia in hand and/or wrist
    joints.
    6. The subject has active disease at both Screening and Baseline, as defined by both:
    a. ≥6 joints tender or painful on motion, AND
    b. ≥6 joints swollen;
    and fulfills 1 of the following 2 criteria at Screening:
    i. Erythrocyte sedimentation rate (ESR) (Westergren method) above the upper limit of normal in the local laboratory
    ii. C-reactive protein (CRP) >7 mg/L in the central laboratory
    7. The subject meets ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II or III (Appendix 1).
    8. Subjects receiving non-prohibited concomitant medications for any reason must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to first study dose, or as defined in Concomitant Medications (Section 5.5).
    9. Subjects must have failed an adequate study of therapy with at least 1 DMARD due to lack of efficacy or toxicity. See inclusion criteria 10 and exclusion criteria 1 and 12.
    10. Subjects having received the following treatment regimens are eligible, provided the following discontinuation periods are observed. Note that none of these therapies should be discontinued by a subject to allow participation in this study if they are currently effective and tolerated.
    a. Within 4 weeks of first dose of study drug:
    DMARDS – leflunomide (Arava® ) (see additional washout information for leflunomide in Appendix 10), auranofin (oral gold), injectable gold (aurothioglucose or aurothiomalate), methotrexate, sulfasalazine, and d-penicillamine, minocycline; etanercept (Enbrel®); anakinra (Kineret®);
    Immunosuppressive/Immunomodulatory therapies -azathioprine,
    cyclosporine, and PROSORBA® device/column;
    NSAIDs - any experimental NSAIDs or experimental selective COX-2
    inhibitors;
    Other - herbal medications, immunization with any live virus vaccination (eg, FluMist™), intra-articular, intramuscular, or intravenous corticosteroids;
    b. Within 8 weeks of first dose:
    infliximab (Remicade®);
    c. Within 3 months of first dose:
    abatacept (Orencia®);
    d. Within 6 months of first dose:
    any experimental therapy for RA (other than experimental NSAIDs,
    selective COX-2 inhibitors and selective B lymphocyte depleting agents);
    E.4Principal exclusion criteria
    1. Subjects who discontinued any previous TNFi therapy for either lack of efficacy or adverse events. Subjects who previously received adalimumab therapy for any reason are not allowed in the study.
    2. Subjects with evidence of hematopoietic disorders:
    a. Hemoglobin levels <9.0 gm/dL or hematocrit <30% at screening visit or within the 3 months prior to first study dose.
    b. An absolute white blood cell count of <3.0 x 109/L or absolute neutrophil count of <1.2 X 109/L at screening visit or within the 3 months prior to first study dose.
    c. Thrombocytopenia, as defined by a platelet count <100 x 109/L at screening visit or within the 3 months prior to first study dose.
    3. Estimated GFR ≤50 ml/min based on Cockcroft-Gault calculation.
    4. Pregnant or lactating women.
    5. Total bilirubin, AST or ALT more than 2 times the upper limit of normal at screening visit.
    6. Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
    7. History of an infected joint prosthesis at any time, with the prosthesis still in situ.
    8. Current routine household contact with children who have received varicella or oral polio vaccine within 2 months prior to first study dose, or during the 24 weeks of treatment and for 4 weeks following completion of the study.
    9. History of any lymphoproliferative disorder, history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current lymphatic disease.
    10. Evidence of active or latent infection with Mycobacterium tuberculosis, as defined by any of the following:
    a. A subject has a positive Mantoux Purified Protein Derivative (PPD) skin test result of ≥5 mm of induration within the 3 months prior to screening, OR
    b. A subject is immunoreactive for TB using an ex vivo method, OR
    c. A subject has a chest radiograph that has changes suggestive of active TB infection.
    11. Subjects with clinically significant infections currently or within 6 months of first dose of study drug (eg, those requiring hospitalization or parenteral antimicrobial therapy or opportunistic infections), or those with a history of more than one episode of herpes simplex or zoster, a history of disseminated zoster, a history of any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study or any infection requiring antimicrobial therapy within 2 weeks of screening.
    12. Any prior treatment with lymphocyte-depleting agents/therapies (such as
    CamPath®[alemtuzab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc). Subjects who have received rituximab or other selective B lymphocyte depleting agents are eligible if they have not received such therapy for at least 1 year prior to first dose (see Appendix 10 for wash out procedure).
    13. Subjects with any condition possibly affecting oral drug absorption (eg,
    bariatric/obesity surgery [such as gastric bypass or gastric banding], gastrectomy, or clinically significant diabetic gastroenteropathy).
    14. History of alcohol or drug abuse with less than 6 months of abstinence prior to first dose of study drug.
    15. Screening 12-lead ECG that demonstrates clinically relevant abnormalities which may affect subject safety or interpretation of study results.
    16. Donation of blood in excess of 500 mL within 2 months prior to first study dose.
    17. Subjects with an oral or tympanic temperature of 38°C or higher at Screening.
    18. Subjects with a first-degree relative with a hereditary immunodeficiency.
    19. Subjects with malignancies or with a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
    20. Significant trauma or major surgery within 4 weeks of screening visit.
    21. Subjects requiring prohibited concomitant medications listed in Appendix 5 of the protocol.
    22. Subjects infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses.
    23. Subjects who have previously participated in any study of CP-690,550.
    24. Subjects who, in the opinion of the investigator or Pfizer, will be uncooperative or unable to comply with study procedures.
    25. Any other condition which would make the subject unsuitable for inclusion in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary:
    • American College of Rheumatology 20 (ACR 20) responder rate at the Week
    12 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 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 Yes
    E.6.13.1Other scope of the trial description
    Molecular Profiling
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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 years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Legal representative can give consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 350
    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 possibility will be offered for the patients to participate in A3921024 open-label, extension study.
    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 Decision2008-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-01-14
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