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    The EU Clinical Trials Register currently displays   44157   clinical trials with a EudraCT protocol, of which   7327   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:2009-014296-40
    Sponsor's Protocol Code Number:A3921032
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-12-29
    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 ConcernedAustria - BASG
    A.2EudraCT number2009-014296-40
    A.3Full title of the trial
    PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS
    A.4.1Sponsor's protocol code numberA3921032
    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 nametasocitinib (proposed INN)
    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-690,550-10
    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.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
    Rheumatoid arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    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
    1. To compare efficacy of CP 690,550 5 mg BID & 10 mg BID vs placebo for treatment of signs & symptoms of RA, in patients with RA on background MTX who have had an inadequate response (IR) to a TNF-i as measured by ACR20 response rates at M3
    2. To compare physical function status of patients with active RA on bkg MTX who have had IR to a TNF-i after administration of CP 690,550 5 mg BID & 10 mg BID vs placebo, as measured by HAQ DI response at M3
    3. To compare rate of achieving DAS284(ESR) <2.6 at Month 3 in patients with active RA on bkg MTX who have had IR to a TNF-i after administration of CP-690,550 5 mg BID & 10 mg BID vs placebo
    4. To compare the safety and tolerability of CP-690,550, in doses of 5 mg BID and 10 mg BID, vs placebo in patients with RA on background methotrexate who have had an inadequate response to a TNF inhibitor.
    E.2.2Secondary objectives of the trial
    1. To compare efficacy of CP 690,550 5 mg BID & 10 mg BID vs placebo for treatment of signs & symptoms of RA in patients with RA on bkg MTX who have had IR to a TNF-i at all other time points as measured by ACR20, ACR50, ACR70 & DAS28 response rates
    2. To compare incidence of DAS28<2.6 & DAS28 ≤3.2 at each visit.
    3. To compare effects on all health outcomes measures at each visit as appropriate for the specific outcome compared to baseline
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for inclusion in this study, patients must meet all of these criteria:
    1. Active rheumatoid arthritis (RA);
    2. Ongoing treatment with an adequate and stable dose of methotrexate;
    3. In the opinion of the investigator, at least one approved TNF-inhibiting biologic agent administered in accordance with its labeling recommendations was inadequately effective and/or not tolerated.
    4. All other inclusion criteria.
    Active Rheumatoid Arthritis
    1. Meet the ACR classification criteria for RA
    2. Must have active disease at both screening and baseline, as defined by having both:
    a. ≥6 tender/painful joints on motion (out of 68 joints assessed); and; b. ≥6 swollen joints (out of 66 joints assessed).
    3. Must also have active disease, as defined by one of the following criteria at screening:
    a. Erythrocyte sedimentation rate (ESR) (Westergren method) >28 mm/hr; or b. C-
    reactive protein (CRP) >7 mg/L in the central laboratory.
    4. Must meet Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA.
    Background Methotrexate
    1. Must have taken oral or parenteral methotrexate continuously for at least 4 months prior to the first dose of study medication and be on a stable dose of 7.5 mg
    to 25 mg weekly, for at least 6 weeks prior to the first dose of study medication.
    Stable weekly doses less than 15 mg are allowed only in the presence of intolerance
    to or toxicity from higher doses or where higher doses would violate the local label.
    Doses higher than 25 mg weekly are not permitted under any circumstances.
    2. Patients should be on an adequate and stable dose of folic acid (not less than 5
    mg weekly, unless higher doses would violate the local label) for at least 4 weeks
    prior to the first dose of study medication.
    1. Evidence of a signed and dated informed consent document.
    2. Must be at least 18 years of age.
    3. 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 study.
    4. No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as described in the protocol
    5. For traditional DMARDS, the following minimum washout criteria apply:
    • Minocycline, Penicillamine, Sulfasalazine: must have been discontinued for 4 weeks
    prior to the first dose of study drug.
    • Leflunomide (Arava®) must have been discontinued 8 weeks prior to the first dose
    of study drug if no elimination procedure is followed. Alternately, it should have been
    discontinued with the specified elimination procedure at least 4 weeks prior to the
    first dose of study drug.
    • Auranofin (Ridaura®), Injectable Gold (aurothiglucose or aurothiomalate): must
    have been discontinued for 8 weeks prior to first dose of study drug.
    • Antimalarials (Hydroxychloroquine, Chloroquine): Antimalarials will be allowed in
    this study. If discontinued, they must be discontinued for 4 weeks prior to the first
    dose of study drug. If continued, the dose must be stable for at least 8 weeks prior
    to first dose of study drug.
    6. Biologic Response Modifiers. All must be discontinued for entry into this study:
    • Anakinra (Kineret®), Enbrel (Etanercept®);
    Discontinued for 4 weeks prior to the first dose of study drug;
    • Adalimumab (Humira®): Discontinued for 6 weeks prior to first dose of study drug;
    • Infliximab (Remicade®): Discontinued for 8 weeks prior to the first dose of study drug;
    •Golimumab (Simponi TM): Discontinued for 10 weeks prior to the first dose of
    study drug;
    • Abatacept (Orencia®), Tocilizumab (Actemra®), Certolizumab pegol (Cimzia®):
    Discontinued for 12 weeks prior to first dose of study drug;
    • Rituximab or other selective B lymphocyte depleting agents (either marketed or
    investigational): Discontinued for 1 year prior to the first dose of study drug and if
    D19/20+ counts are normal by FACS analysis;
    7. Other:
    a. Oral corticosteroids: Patients who are already on oral corticosteroids must be on
    a stable dose of ≤10 mg/day of prednisone or equivalent for 4 weeks prior to first dose of study drug. b. Intraarticular, intramuscular, or intravenous corticosteroids: None may be administered within 4 weeks prior to first dose of study drug. c. cyclosporine, Tacrolimus, Azathioprine: All must be discontinued 4 weeks prior to the first dose of study drug. d. Prosorba Device/Column: This must be discontinued 4
    weeks prior to the first dose of study drug. e. Experimental NSAIDS (including Cox-2
    inhibitors): These must be discontinued 4 weeks prior to the first dose of study drug.
    f. Any investigational treatment not mentioned elsewhere must be discontinued for 4
    weeks or 5 half lives, whichever is longer.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    1. Any prior treatment with non B lymphocyte-selective lymphocyte depleting agents/therapies, such as alemtuzumab (Campath®) OR alkylating agents (eg, cyclophosphamide or chlorambucil) OR 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.
    2. Pregnant or lactating females.
    3. Blood dyscrasias including confirmed:
    - Hemoglobin <9 g/dL or Hematocrit <30%;
    - White blood cell count <3.0 x 10^9/L;
    - Absolute neutrophil count <1.2 x 10^9/L;
    - Platelet count <100 x 10^9/L.
    4. Estimated GFR less than 40 ml/min based on Cockcroft-Gault calculation.
    5. AST or ALT more than 1.5 times the upper limit of normal at screening visit.
    6. Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, metabolic, pulmonary, cardiac, or neurological disease.
    7. History of any other autoimmune rheumatic disease other than Sjogren’s
    syndrome.
    8. History of an infected joint prosthesis at any time, with the prosthesis still in situ.
    9. 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.
    10. History of 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. A history of recurrent (more than one episode) herpes zoster, disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
    13. A patient who was vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of study drug, expects to be vaccinated or exposed to these vaccines during treatment, or during the 6 weeks following discontinuation of study drug. (See Section 4.5.2. for further information regarding avoidance of household contacts who may be vaccinated).
    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 substance abuse, unless in full remission for greater than 6 months prior to first dose of study drug.
    16. Screening 12-lead ECG that demonstrates clinically relevant abnormalities which may affect patient safety or interpretation of study results.
    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 major surgery within 1 month of screening visit.
    20. A patient requiring prohibited concomitant medications including prohibited dietary supplements. Prohibited concomitant medications must be discontinued at least 4 weeks prior to the first dose of study drug, with the exception of amiodarone which must be discontinued for at least 290 days prior to the first dose of study drug.
    21. A patient infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses.
    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. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug 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.
    25. A patient who, in the opinion of the Investigator or Pfizer, will be uncooperative or unable to comply with study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    1. American College of Rheumatology 20 (ACR20) responder rate versus placebo at the Month 3 visit.
    2. Change from baseline in the Health Assessment Questionnaire (HAQ-DI) vs. placebo at the Month 3 visit.
    3. Incidence rate for DAS28-4 (ESR) <2.6 versus placebo at the Month 3 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 No
    E.6.7Pharmacodynamic No
    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
    Optional Molecular Profiling Supplement
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    End of Trial os defined in the protocol amd 2, dated 10th May 2010, section 13.
    End of Trial in all participating countries is defined as Last Patient Last Visit.
    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 months6
    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 months6
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 396
    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 Decision2010-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-03-17
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