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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2008-007023-26
    Sponsor's Protocol Code Number:A3921044
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-04-03
    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 ConcernedGreece - EOF
    A.2EudraCT number2008-007023-26
    A.3Full title of the trial
    PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE
    A.4.1Sponsor's protocol code numberA3921044
    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.3.2Product code CP-690,550
    D.3.4Pharmaceutical form Film-coated 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.3.10 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    CP 690,550 is being studied as a disease modifying antirheumatic drug for the treatment of moderate to severe active rheumatoid arthritis in adults.
    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 study is designed to provide pivotal efficacy data supporting four proposed claims (reducing signs & symptoms, inhibiting the progression of structural damage, inducing major clinical response, & improvement in physical function) & 2 yr safety data for CP 690,550 dosed at 5 & 10 mg BID in patients with inadequate response to stable weekly doses of background methotrexate.
    The primary objectives are to compare both doses of CP-690,550 versus placebo in patients with active RA on a stable background of methotrexate:
    1. For signs & symptoms as measured by ACR20 response rates at Month 6.
    2. For evidence of joint structure preservation as measured by changes from baseline using a validated method, such as the van der Heijde modified Sharp score.
    3. For physical function status of patients using the HAQ DI at Month 3 compared to baseline.
    4. For safety & tolerability.
    E.2.2Secondary objectives of the trial
    Secondary objectives will compare 5 mg and 10 mg of CP-690,660 BID versus placebo in patients with active RA on stable doses of background methotrexate for:
    1. The treatment of signs and symptoms of RA measured by ACR20 response rates at Months 1 and 3 and ACR50, ACR70 and DAS 28 response rates at Months 1, 3, and 6.
    2. The durability of ACR20, ACR50, and ACR70 and DAS 28 response rates.
    3. The incidence of DAS 28 remission and low disease activity state at each visit.
    4. Effects on all health outcomes measures in the study at each visit, as appropriate for the specific outcome, compared to baseline.
    The study will include the collection of de-identified biological samples. An additional informed consent document is required and the Molecular Profiling Supplement contains further information and details regarding this sampling; participation is optional.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Active, moderate to severe, rheumatoid arthritis with joint erosions or positive IgM Rheumatoid Factor or antibodies to cyclic citrullinated peptide
    2. Be on an adequate and stable dose of methotrexate
    3. Meet all eligibility criteria outlined below.
    Active RA-Patients must meet all the following criteria:
    1. Meet the ACR classification criteria for the diagnosis of RA by satisfying at least four of the seven criteria.
    2. Have at least three distinct joint erosions on posteroanterior (PA) hand and wrist or anteroposterior (AP) foot radiographs OR if this is not available, must have a positive IgM rheumatoid factor OR antibodies to cyclic citrullinated peptide
    3. The patient must have active disease at both screening and baseline, as defined by having both ≥6 tender/painful joints on motion, and; ≥6 swollen joints.
    4. At screening must have either Erythrocyte sedimentation rate (ESR) (Westergren method) >28 mm/hr or C reactive protein (CRP) >7 mg/L
    5. The patient must meet Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA.
    Background Methotrexate:
    All local standard of care practices for use of methotrexate, including laboratory testing, follow up care, contraindications, and folic acid administration should be performed throughout the study.
    Minimum guidelines for methotrexate and folic acid therapy during study:
    1. Must have taken oral or parenteral methotrexate continuously for at least 4 months and be on a stable weekly dose for at least 6 weeks. Weekly doses less than 15 mg are allowed only in the presence of intolerance or toxicity or where higher doses violate the local label. Doses higher than 25 mg weekly are not permitted.
    2. Be on a stable dose of folic acid not less than 5 mg weekly, unless higher doses would violate the local label, for at least 4 weeks.
    3. Must have an inadequate clinical response to methotrexate defined as the presence of sufficient residual disease activity to meet the entry criteria.
    Other Inclusion Criteria:
    Patients with a diagnosis of rheumatoid arthritis, on an adequate dose of methotrexate, and must meet the remaining inclusion criteria to be eligible for enrollment into the trial:
    1. Evidence of a signed and dated informed consent document
    2. Must be at least 18 years of age or older
    3. Must discontinue all disallowed concomitant medications for the required time and is taking only those concomitant medications in doses and frequency allowed by the protocol.
    4. Women of childbearing potential must test negative for pregnancy prior to enrollment in this study;
    5. Sexually active women of childbearing potential and men whose partners are women of childbearing potential are required to use adequate contraceptive methods during participation in this trial, as required for men and women on methotrexate therapy.
    6. No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by all of the following:
    •A negative QuantiFERON® TB Gold In Tube test or Mantoux Purified Protein Derivative skin test result of <5 mm of induration (<20 mm erythema in Japan), within 3 months prior to screening.
    •A chest radiograph within 3 months prior to screening without changes suggestive of active TB infection;
    •No history of untreated or inadequately treated latent or active TB infection.
    If a patient has received an adequate course of therapy for either latent (9 months of isoniazid in a locale where rates of primary multi drug resistant TB infection are <5% or an acceptable alternative regimen) or active (acceptable multi drug regimen) TB infection, neither a PPD test nor a QuantiFERON® TB Gold In Tube test need be obtained, but a chest radiograph must still be obtained. A patient who is currently being treated for latent or active TB infection can be enrolled with confirmation of current incidence rates of multi drug resistant TB infection, documentation of an adequate treatment regimen, and prior approval of the Sponsor.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    1. Pregnancy or currently lactating.
    2. Blood dyscrasias, including confirmed:
    a. Hemoglobin <9 g/dL or Hematocrit <30%;
    b. White blood cell count <3.0 x 10 to the power of 9/L;
    c. Absolute neutrophil count <1.2 x 10 to the power of 9/L;
    d. Platelet count <100 x 10to the power of 9/L.
    3. Estimated GFR <40 ml/min based on Cockcroft Gault calculation.
    4. AST or ALT greater than 1.5 times the upper limit of normal at screening or any uncontrolled clinically significant laboratory abnormality that would affect interpretation of study data or the patient’s participation in the study.
    5. Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, metabolic, pulmonary, cardiac, or neurological disease.
    6. History of any other rheumatic autoimmune disease, other than Sjogren’s syndrome
    7. History of an infected joint prosthesis at any time, with the prosthesis still in situ.
    8. History of any lymphoproliferative disorder, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease.
    9. History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
    10. History of any infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug.
    11. History of any infection requiring antimicrobial therapy within 2 weeks prior to the first dose of study drug.
    12. Any prior treatment with non B cell specific lymphocyte depleting agents/therapies [eg, alemtuzumab (Campath®), alkylating agents (eg, cyclophosphamide or chlorambucil), total lymphoid irradiation, etc]. Patients who have received rituximab or other selective B lymphocyte depleting agents (including experimental agents) are eligible if they have not received such therapy for at least 1 year prior to study baseline and have normal CD 19/20+ counts by FACS analysis.
    13. Any patient who has been vaccinated with live or attenuated vaccines within the 6 weeks prior to the first dose of study drug or is to be vaccinated with these vaccines at any time during treatment or within 6 weeks following discontinuation of study drug.
    14. A patient with any condition possibly affecting oral drug absorption, eg, gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass. Procedures such as gastric banding, that simply divide the stomach into separate chambers, are NOT exclusionary.
    15. History of alcohol or drug abuse with less than 6 months of abstinence prior to first dose of study drug.
    16. Screening 12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect patient safety.
    17. A patient with a first degree relative with a hereditary immunodeficiency.
    18. A patient with a malignancy or with a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
    19. Significant trauma or surgery procedure within 1 month prior to first dose of study drug.
    20. A patient requiring prohibited concomitant medications including prohibited dietary supplements.
    21. A patient known to be infected with human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus.
    22. A patient who has previously participated in any study of CP 690,550.
    23. A patient who has an allergy/hypersensitivity to methotrexate, or previous serious toxicity when administered methotrexate.
    24. Participation in studies of investigational compounds within 4 weeks or 5 half lives (whichever is longer) prior to the first dose of study drug. Patients cannot participate in studies of other investigational compounds at any time during their participation in this study. Exposure to investigational biologics should be discussed with the Pfizer Medical Monitor.
    25. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    Multiple endpoints will be evaluated during the study to meet the stated objectives. Specifically, they are:
    Signs & Symptoms
    • ACR20 responder rates analyzed at all timepoints.
    • ACR50 and ACR70 responder rates at all timepoints.
    • DAS 28 3 and DAS 28 4 (CRP) at all timepoints.
    • DAS 28 3 and DAS 28 4 (ESR) at all timepoints at participating sites (dependent upon availability of a local laboratory that can report ESR results directly to the central laboratory, to ensure blinding of data).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Molecular Profiling Supplement - date 20 August 2008 (optional)
    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) 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 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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    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 years2
    E.8.9.2In all countries concerned by the trial months10
    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 No
    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 150
    F.4.2.2In the whole clinical trial 750
    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)
    Follow up for clinically significant, treatment-emergent abnormalities or abnormal laboratory events are described in the protocol. Additionally, after completing study A3921044, patients may be eligible to continue treatment with CP-690,550 in open label study A3921024 (EudraCT No 2006-005035-19). Patients who have taken at least one dose of CP-690,550 and have discontinued may be eligible to enter A3921029 a non-interventional follow up study (EudraCT No 2006-006373-25).
    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 Decision2009-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-10
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    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
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