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    Summary
    EudraCT Number:2011-005689-39
    Sponsor's Protocol Code Number:A3921119
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-23
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2011-005689-39
    A.3Full title of the trial
    A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,
    DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)
    RANDOMIZOVANÁ, DVOJITĚ ZASLEPENÁ, PLACEBEM KONTROLOVANÁ STUDIE FÁZE 2, S RŮZNÝM ROZMEZÍM DÁVEK, O ÚČINNOSTI A BEZPEČNOSTI TOFACITINIBU U PACIENTŮ S AKTIVNÍ ANKYLOZUJÍCÍ SPONDYLITIDOU (AS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)
    A.4.1Sponsor's protocol code numberA3921119
    A.7Trial is part of a Paediatric Investigation Plan No
    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, 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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street AddressEast 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 800 7181021
    B.5.5Fax number001 303 739 1119
    B.5.6E-mailClinicalTrials.govCallCentrere@pfizer.com
    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-690,550-10
    D.3.2Product code CP-690,550-10
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTofacitinib
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550-10
    D.3.9.3Other descriptive nameTOFACITINIB CITRATE
    D.3.9.4EV Substance CodeSUB33105
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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-690,550-10
    D.3.2Product code CP-690,550-10
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTofacitinib
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550-10
    D.3.9.3Other descriptive nameTOFACITINIB CITRATE
    D.3.9.4EV Substance CodeSUB33105
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    D.8 Placebo: 2
    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
    Ankylosing Spondylitis (AS)
    E.1.1.1Medical condition in easily understood language
    a type of inflammatory arthritis that affects parts of the spine, including the bones, muscles and ligaments
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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 the efficacy of tofacitinib, in doses of 2 mg BID, 5 mg BID, 10 mg BID versus placebo on the ASAS20 response rate at Week 12 in subjects with active AS that have had an inadequate response to previous treatment.
    2. To estimate the placebo-corrected dose response for the ASAS20 at Week 12 in subjects with active AS that have had an inadequate responst to previous treatment.
    3. To compare the safety of tofacitinib at all doses versus placebo in all study subjects.
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
    2. Subjects who are willing and able to comply with scheduled visits, treatment plan,laboratory tests, and other study procedures.
    3. Subject is at least 18 years old (20 years old for subjects in Taiwan) at the Screening Visit.
    4. The subject has a diagnosis of AS based on the Modified New York Criteria for Ankylosing Spondylitis (1984).
    5. Subject has active AS at the Screening and Baseline (Day 1) visits defined as:
    • BASDAI score of >=4; and
    • Back pain score (BASDAI Question 2) of >=4.
    6. Subject has active disease despite concurrent nonsteroidal anti-inflammatory drug (NSAID) therapy or is intolerant to NSAIDs.
    7. Subject must have had an adequate trial of at least 2 different oral NSAIDs taken over a total period of 4 weeks.
    8. Subjects may be receiving the following traditional DMARDs at the time of the Screening visit. These medications should be continued throughout the entire study and doses should remain unchanged. Any other DMARDs require discussion prior to enrollment with the sponsor for washout timeframe.
    • Methotrexate: Maximum dose of 20 mg/week. Minimum duration of therapy 4 months and dose stable for 4 weeks prior to first dose of study drug. Subjects on methotrexate should be on an adequate and stable dose of folate supplementation (eg, not less than 5 mg weekly based on folic acid, unless such doses would violate the local label guidelines or standard of care) for at least 4 weeks prior to the first dose of study drug. Subject must not have had previous serious toxicity while on
    methotrexate and not be expected to require evaluation for possible methotrexate toxicity (eg, require a liver biopsy for methotrexate toxicity) during the study; • Sulfasalazine (Azulfidine, Salazpyrin): Maximum dose of 3 gm/day. Minimum duration of therapy 2 months and dose stable for 4 weeks prior to first dose of study drug.
    9. Subjects who are already taking oral corticosteroids (not injectables) may participate in the study:
    • Oral corticosteroids: Subjects who are already receiving oral corticosteroids must be
    on a stable dose of =<10 mg/day of prednisone or equivalent for 4 weeks prior to the first dose of study medication;
    • Injected (eg, intraarticular, intramuscular, epidural or intravenous) corticosteroids
    must be discontinued 4 weeks prior to the first dose of study medication;
    • Topical corticosteroids will be allowed during the study.
    10. Subject has discontinued all disallowed concomitant medication for the required time prior to the first dose of study medication and is taking only those concomitant medications in doses and frequency allowed by the protocol.
    11. Subjects who are receiving any investigational or marketed treatment for AS, arthritis or back pain not mentioned elsewhere must have that treatment discontinued for 4 weeks or 5 half-lives, whichever is longer.
    12. Subjects receiving non-prohibited concomitant medications for any reason must be willing to stay on a stable regimen as defined in the protocol.
    13. No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined in protocol.
    14. Women of childbearing potential must test negative for pregnancy prior to enrollment in this study.
    15. Female subjects who are not of childbearing potential (ie, meet at least one of the following criteria): • Have undergone hysterectomy or bilateral oophorectomy; • Have medically confirmed ovarian failure; • Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause); laboratory confirmation of FSH level indicative of post menopausal according to the central laboratory may be indicated per investigator’s determination.
    E.4Principal exclusion criteria
    1. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
    2. Participation in other interventional studies within 4 weeks before the current study begins and/or during study participation. 3. Subjects receiving any other DMARDs (other than those allowed), thalidomide (including previous use).
    4. Subjects currently receiving or previous use of a TNF inhibitor or other biological agent.
    5. Blood dyscrasias at screening or within 3 months prior to the first dose of study drug including confirmed:
    a. Hemoglobin <10 g/dL;
    b. Absolute white blood cell count (WBC) <3.0 x 10 9/L (<3000 mm3);
    c. Absolute neutrophil count (ANC) <1.2 x 10 9/L (<1200 mm3);
    d. Absolute lymphocyte count <0.5 x 10 9/L (<500/mm3);
    e. Platelet count <100 x 10 9/L (<100,000/mm3).
    One re-testing of an uncompromised sample (eg, not out of stability, not hemolyzed) is allowed of any above parameters if the abnormal lab(s) was an uncharacteristic result(s). Documentation in the source of the typical results to allow a repeat lab is required.
    Re-test must be completed within the screening period.
    6. Estimated Creatinine Clearance <40 ml/min based on Cockcroft Gault equation at Screening visit.
    7. Total bilirubin, AST or ALT more than 1.5 times the upper limit of normal at screening visit. (One re-testing with an uncompromised sample is allowed if the abnormal lab result was an uncharacteristic result and must be completed within the screening period. Documentation in the source of the typical results to allow a repeat lab is required).
    8. History of any other autoimmune rheumatic disease (eg, systemic lupus erythematosis (SLE), mixed connective tissue disease (MCTD), scleroderma, polymositis) or known diagnosis of fibromyalgia, without approval by Sponsor.
    9. History of an infected joint prosthesis at any time, with the prosthesis still in situ.
    10. History of any lymphoproliferative disorder, such as Epstein Barr Virus related
    lymphoproliferative disorder (EBV-LPD), history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease.
    11. History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
    12. 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 medication.
    13. History of infection requiring antimicrobial therapy within 2 weeks prior to the first dose of study medication.
    14. Any prior treatment with alkylating agents (eg, cyclophosphamide or chlorambucil), total lymphoid irradiation, etc. 15. Any subject who has been vaccinated with live or attenuated vaccines within the 6 weeks prior to the first dose of study medication or is to be vaccinate with these vaccines at any time during treatment or within 6 weeks after last dose of study drug.
    16. A subject 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. 17. History of alcohol or drug abuse unless in full remission for greater than 6 months prior to first dose of study medication.
    18. Body weight or body habitus greater than what can be accommodated by the site’s MRI scanner table weight limits or MRI scanner bore.
    19. Any contraindication to MRI that in the judgment of the investigator and MRI center poses a safety risk to the subject such as, but not limited to, cardiac pacemaker; implanted cardiac defibrillator; aneurysm clips; carotid artery vascular clamp; neurostimulator; insulin or infusion pumps; bone growth/fusion stimulator; cochlear, otologic, and ear implants.
    20. Subjects with passive implants that may be weakly ferromagnetic in the vicinity of the RF coil that may cause image artifacts in the spine and SI joints.
    For exclusion criteria 21-30 see protocol.
    E.5 End points
    E.5.1Primary end point(s)
    - ASAS 20 response rate
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    A validated endpoint such as Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score and/or modified Berlin Ankylosing Spondylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the SI joints and spine at Week 12.
    •ASAS20 response at all other time points.
    •ASAS40 response at all time points.
    •ASAS 5/6 response at all time points.
    •Ankylosing Spondylitis Disease Activity Score using C-Reactive Protein
    (ASDASCRP) at all time points.
    •ASDAS clinically important improvement, ASDAS major improvement and ASDAS inactive disease at all time points.
    •Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at all time points.
    •BASDAI50 response at all time points.
    •Bath Ankylosing Spondylitis Functional Index (BASFI) at all time points.
    •Bath Ankylosing Spondylitis Metrology Index (BASMI) at all time points.
    •Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at all time points collected.
    •Extra-articular Involvement (Specific Medical History and peripheral articular involvement [as assessed by swollen joint count]) at all time points collected.
    •Spinal mobility at all time points collected.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 2, 4, 8, 12
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    patient reported outcomes
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Czech Republic
    Germany
    Hungary
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    Taiwan
    United States
    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
    LVLS
    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 years2
    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) No
    F.1.2.1Number of subjects for this age range: 190
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 108
    F.4.2.2In the whole clinical trial 200
    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)
    No special measures; subjects may be treated as per standard local practice outside the scope of the clinical trial
    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 Decision2013-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-18
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