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    Summary
    EudraCT Number:2006-005035-19
    Sponsor's Protocol Code Number:A3921024
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-04
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-005035-19
    A.3Full title of the trial
    A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550, A MODERATELY SELECTIVE JANUS-KINASE-3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberA3921024
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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
    B.1.3.4CountryItaly
    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.3.10 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 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.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.3.10 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 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
    Relief of signs and symptoms, improvement of physical function, and structure preservation in rheumatoid arthritis RA .
    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
    To determine the long term safety and tolerability of 5 mg BID of CP-690,550 for treatment of the signs and symptoms of RA.
    E.2.2Secondary objectives of the trial
    To evaluate the persistence of efficacy of CP-690,550 for treatment of the signs and symptoms of RA.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Ability to provide a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the trial. 2. Subject must be at least 18 years of age at the time of consent. 3. Subjects must either have previously completed study A3921019 or withdrawn from that study due to a. lack of efficacy if assigned to placebo arm OR b. unrelated AE or unrelated SAE with permission if assigned to 5 mg BID group OR c. any AE/SAE, if assigned to the 15 or 30 mg BID arms, except that subjects with treatment related SAE in A3921019 must obtain permission from sponsor to participate in A3921024. Such subjects are eligible for participation in A3921024 until 3 months after the initiation date of their original A3921019 study site for A3921024. If that site is not planned to participate in A3921024, then the nearest geographic site within the subject s country will be considered for these purposes. 4. Subjects must have previously completed at least 12 weeks participation in any other randomized qualifying study of CP-690,550 for the treatment of RA as long as not withdrawn due to treatment related AE or SAE. Subjects withdrawn due to unrelated AE or SAE must obtain sponsor permission before participating in this study. If subjects cannot combine the end of study visit for the previous CP-690,550 study with the screening/baseline visit for A3921024, they will be allowed a 7 day window in which to enroll into A3921024. 5. No alternative diagnosis of primary arthritic condition other than RA since time of completion of the qualifying study 6. For a subject who was previously in study A3921019, he/she must show evidence of continued active rheumatoid arthritis, defined as at least 6 swollen and 6 tender joints Continued Disease Activity Assessment Section 7.1.1 and elevation of either C reactive protein CRP or erythrocyte sedimentation rate ESR above the upper limit of normal of the reference laboratory at screening. 7. The patient has discontinued disallowed DMARD or immunosuppressive/immunomodulatory therapies prior to first dose of study medication, as defined in Appendix C. 8. If the subject is a sexually active woman of childbearing potential, she and any male partner must be willing to agree to contraceptive practices as detailed in the Lifestyle Guidelines of the protocol. 9. 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. 10. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
    E.4Principal exclusion criteria
    For Subjects who participated in A3921019 1-5 1. Evidence of hematopoietic disorders or evidence of hemoglobin levels 9 gm/dL or hematocrit 30 at screening visit or within the 3 months prior to baseline visit. 2. An absolute white blood cell WBC count of 3.0 x 10 9 /L 3000/mm3 or absolute neutrophil count of 1.2 x 10 9 /L 1200/mm3 at screening visit or within 3 months prior to baseline. 3. Thrombocytopenia, as defined by a platelet count 100 x 10 9 /L 100,000/mm3 at screening visit or within 3 months prior to baseline. 4. Estimated creatinine clearance 50 mL/hr by Cockroft Gault equation Appendix F at screening visit. 5. Total bilirubin, AST or ALT more than 1.5 times the upper limit of normal at screening visit. For All subjects 6. Pregnant or lactating women. 7. Current or recent history of severe, progressive, uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological disease. 8. History of an infected joint prosthesis at any time, with the prosthesis still in situ. 9. History of any lymphoproliferative disorder such as EBV related lymphoproliferative disorder, as reported in some patients on other immunosuppressive drugs , history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease. 10. History of untreated infection with M. tuberculosis TB as defined by any of the following a. Chest radiograph taken within the 12 months prior to the baseline visit that has changes suggestive of active TB b. A positive tuberculin PPD skin test, which must have been performed and evaluated by a trained health professional within the 12 months prior to the baseline visit regardless of BCG vaccination status with 5 mm of induration without adequate anti TB therapy c. Immuno-reactivity to M tuberculosis by QuantiFERON Gold test 11. Patients with clinically significant infections within the 6 months prior to the baseline visit those requiring hospitalization, requiring parenteral antimicrobial therapy or judged to be opportunistic by the investigator , or those with recurrent oral or genital herpes, or as otherwise judged by the investigator. 12. Any other condition which would make the patient unsuitable for inclusion in the study. 13. A patient who has received any experimental therapy or biological therapies for RA within or outside a clinical trial within 6 months prior to the baseline visit, with the exception of experimental NSAIDs, coxibs, or opioids which may have been used up to 28 days prior to baseline. 14. Any prior treatment with lymphocyte depleting agents/therapies such as CAMPATH, alkylating agents eg, cyclophosphamide or chlorambucil , total lymphoid irradiation, etc. . Subjects who have received rituximab are eligible if they have not received such therapy for at least 1 year prior to study baseline and have normal CD20 counts by FACS analysis. 15. Intra-articular, intramuscular, or intravenous corticosteroids in the 4 weeks preceding baseline. 16. Patients with any condition possibly affecting oral drug absorption, eg, gastrectomy, clinically significant diabetic gastroenteropathy, or bariatric surgery such as gastric banding or gastric bypass. 17. History of alcohol or drug abuse with less than 6 months of sobriety prior to screening 18. Screening 12 lead electrocardiogram ECG that demonstrates clinically relevant abnormalities that may affect patient safety or interpretation of study results. 19. Patients with an oral or tympanic temperature at screening or prior to dosing of 38 C or higher. 20. Patients with a first degree relative with a hereditary immunodeficiency.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints will be standard laboratory safety data chemistry, hematology, etc. and adverse event AE reports.
    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 No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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 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 2007-07-04. 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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 550
    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 Opinion2007-02-08
    P. End of Trial
    P.End of Trial StatusCompleted
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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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