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    Summary
    EudraCT Number:2018-000226-58
    Sponsor's Protocol Code Number:A3921120
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-31
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2018-000226-58
    A.3Full title of the trial
    A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)
    A.4.1Sponsor's protocol code numberA3921120
    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, 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 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 Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 800 7181021
    B.5.5Fax number+1 303 7391119
    B.5.6E-mailClinicalTrials.gov_Inquiries@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 nameTofacitinib 5 mg
    D.3.2Product code CP-690,550
    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.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
    Ankylosing spondylitis (AS)
    E.1.1.1Medical condition in easily understood language
    Type of chronic inflammatory arthritis involving the spine and/or sacroiliac joints.
    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 20.0
    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
    • To compare the efficacy of tofacitinib 5 mg BID versus placebo on the ASAS20 response rate at Week 16 in subjects with active AS that have had an inadequate response to previous treatment.
    E.2.2Secondary objectives of the trial
    To compare the efficacy of tofacitinib 5 mg BID versus placebo on the
    ASAS40 response rate at Week
    16 in subjects with active AS that have had an inadequate response to
    previous treatment.
    • To compare the safety and tolerability of tofacitinib 5 mg BID versus
    placebo in subjects with active AS that have had an inadequate response
    to previous treatment.
    • To compare the efficacy (including health-related quality of life, function, pain, and fatigue )
    of tofacitinib 5 mg BID versus placebo at all time points in subjects with active AS that have had an inadequate response to previous treatment.
    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 legally acceptable representative) has been informed of and is capable of comprehending all pertinent aspects of the study
    2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    3. Subject is at least 18 years old (or the minimum country-specific age
    of consent if > 18) at the screening visit
    4. The subject has a diagnosis of AS based on the Modified New York Criteria for Ankylosing Spondylitis (1984).
    5. The subject must have a radiograph of the SI joints (AP Pelvis) documenting diagnosis of AS. Previous radiographs (up to 2 years old) can be used if they are accepted by the central reader. Otherwise, a new radiograph will be obtained during the screening period.
    6. Subject has active AS Screening and Baseline (Day 1) visits defined as:
    • BASDAI score of ≥4; and
    • Back pain score (BASDAI Question 2) of ≥4.
    7. Subject has active disease despite nonsteroidal anti-inflammatory drug (NSAID) therapy or is intolerant to NSAIDsas defined in the
    protocol. Subjects who are designated as TNFi-IR must have received at least 1, but not more than 2 approved TNF inhibiting biologic agent that was administered in accordance with its labeling recommendations and was inadequately effective after the minimum treatment times listed below and/or not tolerated after one or more doses.
    • At least 3 months of adalimumab treatment;
    • At least 3 months of etanercept treatment;
    • At least 4 infusions of infliximab;
    • At least 3 injections of golimumab;
    • At least 3 months of certolizumab treatment.
    Intolerance is defined as having experienced a treatment-related AE (eg, infusion/injection reactions, infections, laboratory test changes, etc)
    8. Subjects may be receiving the following csDMARDs 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 (MTX): Maximum dose of 25 mg/week. Minimum duration of therapy 4 months and dose stable for 4 weeks prior to first dose of investigational product. Subjects on MTX should be on an adequate and stable dose of folate supplementation per local standards/regulatory approval (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 investigational product. Subject must not have had previous serious toxicity while on MTX and not be expected to require evaluation for possible methotrexate toxicity (eg, require a liver biopsy for methotrexate toxicity) during the study;
    • Sulfasalazine (Azulfidine®, Salazopyrin®): Maximum dose of 3 gm/day. Minimum duration of therapy 2 months and dose stable for 4 weeks prior to first dose of investigational product.
    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 1 week prior to the first dose of investigational product;
    • Injected (eg, intraarticular, intramuscular, epidural or intravenous) corticosteroids must be discontinued 4 weeks prior to the first dose of investigational product;
    • Topical and intra-rectal 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 investigational product.
    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 (doses and frequency) as defined in the protocol.
    13. No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined in the protocol
    14. Women of childbearing potential must test negative for pregnancy prior to enrollment in this study.
    15. Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
    • Achieved post-menopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with/and have a central laboratory confirmation of serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
    • Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    • Have medically confirmed ovarian failure.
    All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
    E.4Principal exclusion criteria
    Investigator site staff members directly involved in the conduct of the
    study and their family members, site staff members otherwise
    supervised by the investigator, or subjects who are Pfizer employees,
    including their family members, directly involved in the conduct of the
    study. Persons who are dependent upon the sponsor, investigator or the
    study site are excluded.
    2. Participation in other studies involving investigational drug(s) within
    4 weeks prior to study entry and/or during study participation
    (excluding noninterventional follow-up during the screening period).
    3. Other acute or chronic medical or psychiatric condition including
    recent (within the past year) or active suicidal ideation or behavior 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 subject inappropriate for entry into this
    study.
    4. History of known or suspected complete ankylosis of the spine.
    5. Subjects that have been exposed to or are currently receiving
    targeted synthetic DMARDS (including JAK inhibitors), or those currently
    on biological DMARDs (ie washout from any current bDMARD required
    per protocol Section 5.8.1), thalidomide (including previous use) and
    other prohibited concomitant medications.
    6. History of allergies, intolerance or hypersensitivity to lactose or
    tofacitinib (CP-690,550). This includes subjects with rare hereditary
    problems of galactose intolerance, the Lapp lactase deficiency or
    glucose-galactose malabsorption. The investigators of potential subjects
    with acquired lactose intolerance should consider whether this is
    sufficiently concerning so as to preclude participation.
    7. Blood dyscrasias at screening or within 3 months prior to the first
    dose of investigational product including confirmed:
    • Hemoglobin <10 g/dL;
    • Absolute white blood cell count (WBC) <3.0 x 10^9/L (<3000 mm3);
    • Absolute neutrophil count (ANC) <1.5 x 10^9/L (<1500 mm3);
    • Absolute lymphocyte count <1.0 x 10^9/L (<1000/mm3);
    • Platelet count <100 x 10^9/L (<100,000/mm3).
    8. Estimated Creatinine Clearance <40 mL/min based on Cockcroft Gault
    equation at Screening visit.
    9. Total bilirubin, AST or ALT more than 1.5 times the upper limit of
    normal (ULN) at screening visit.
    One re-testing of a laboratory-acceptable specimen (eg, appropriately
    labeled, within stability parameters, not hemolyzed, appropriate type
    (tube and reagent) and volume) is allowed of any above parameters if
    the abnormal lab(s) was an uncharacteristic result(s). Re-test must be
    completed within the screening period.
    10. History of any other autoimmune rheumatic disease.
    History of an infected joint prosthesis at any time, with the
    prosthesis still in situ.
    12. History of any lymphoproliferative disorder, such as Epstein Barr
    Virus related lymphoproliferative disease (EBV-LPD), history of
    lymphoma, leukemia, or signs and symptoms suggestive of current
    lymphatic disease.
    13. History of recurrent (more than one episode) herpes zoster or
    disseminated/multi-dermatomal (a single episode) herpes zoster or
    disseminated (a single episode) herpes simplex.
    14. History of infection requiring hospitalization, parenteral
    antimicrobial therapy, or as otherwise judged clinically significant by the
    investigator, within the 3 months prior to the first dose of investigational
    product.
    15. History of infection requiring antimicrobial therapy within 2 weeks
    prior to the first dose of investigational product.
    16. Any prior treatment with non-B cell specific lymphocyte depleting
    agents/therapies (eg, alemtuzamab, efalizumab), alkylating agents (eg,
    cyclophosphamide or chlorambucil), or total lymphoid irradiation.
    17. Any subject who has been vaccinated with live or attenuated
    vaccines within the 6 weeks prior to the first dose of investigational
    product or is to be vaccinated with these vaccines at any time during
    treatment or within 6 weeks after last dose of investigational product.
    18. 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.
    19. A subject that is considered at risk for GI perforation by the
    investigator or Sponsor.
    20. History of alcohol or drug abuse unless in full remission for greater
    than 6 months prior to first dose of investigational product. Subjects
    currently using marijuana.
    Please see section 4.2 of protocol for further exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    • ASAS20 response at Week 16 .
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    E.5.2Secondary end point(s)
    • ASAS40 response at Week 16;
    •Incidence and severity of Adverse Events (AE).
    • Clinical laboratory tests, vital signs, physical examination and 12-lead ECG parameters.
    •ASAS20 response at all other time points.
    - ASAS40 response at all other time points.
    - Change from baseline in Ankylosing Spondylitis Disease Activity Score
    using C-Reactive Protein (ASDASCRP) at all time points.
    - Change from baseline in hsCRP at all time points.
    - Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL)
    at all time points collected
    - Change from baseline in Short-Form-36 Health Survey-Version 2 Acute
    (SF-36v2) at all time points collected.
    - Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL)
    at all time points collected.
    - Change from baseline in Bath Ankylosing Spondylitis Metrology Index
    (BASMI) including the 5 components (lateral spine flexion, tragus-towall
    distance, lumbar flexion, maximal intermalleolar distance and cervical rotation) at all time points.
    -Change from baseline in Functional Assessment of Chronic Illness
    Therapy-Fatigue (FACIT-F) (3 endpoints: total score, experience domain
    and impact domain scores) at all time points.
    - Change from baseline in Patients Global Assessment of Disease (PGA)
    at all time points collected.
    - Change from baseline in Patient's Assessment of Spinal Pain (Total
    Back Pain, Nocturnal Spinal Pain) at all time points collected.
    - Change from baseline in Bath Ankylosing Spondylitis Functional Index
    (BASFI) at all time points.
    - Change from baseline in inflammation (mean of the answers to
    questions 5 and 6 of the BASDAI) at all time points collected.
    - ASAS 5/6 response at all time points.
    - ASAS partial remission criteria at all time points.
    - Change from baseline in Bath Ankylosing Spondylitis Disease Activity
    Index (BASDAI) at all time points.
    - BASDAI50 response at all time points.
    - ASDAS clinically important improvement, ASDAS major improvement
    and ASDAS inactive disease at all time points.
    - Change from baseline in Maastricht Ankylosing Spondylitis Enthesitis
    Score (MASES) at all time points collected.
    - Change from baseline in extra-articular Involvement (Specific Medical
    History and peripheral articular involvement [as assessed by change
    from baseline in swollen joint count]) at all time points collected.
    - Change from baseline in spinal mobility at all time points collected.
    - Change from baseline in EuroQol EQ-5D Health State Profile 3 level
    (EQ-5D-3L) and Your own health state today (EQ-VAS), at all time points
    collected.
    - Change from baseline in Functional Assessment of Chronic Illness
    Therapy-Fatigue (FACIT-F) (3 endpoints: total score, experience domain
    and impact domain scores) at all time points.
    -Change from baseline in Work Productivity and Activity Impairment
    (WPAI) Questionnaire: Spondyloarthritis at all time points collected.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At all timepoints. Please refer to the protocol for additional details
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Open label treatment phase from Week 16 - 48
    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.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    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
    Australia
    Austria
    Belgium
    Bulgaria
    Canada
    China
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Korea, Republic of
    Poland
    Russian Federation
    Slovakia
    Spain
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    United States
    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 in a Member State of the EU is defined as the time at which it is deemed that a sufficient number of subjects have been recruited and completed the study as stated in the regulatory application (ie, clinical trial application [CTA]) and ethics application in the Member State. Poor recruitment (recruiting less than the anticipated number in the CTA) by a Member State is not a reason for premature termination but is considered a normal conclusion to the study in that Member State.
    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 months2
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days14
    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.1.2.1Number of subjects for this age range: 228
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 240
    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)
    None
    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 Decision2018-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-08-20
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