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    Summary
    EudraCT Number:2018-004254-22
    Sponsor's Protocol Code Number:PASTOR2018
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2019-06-25
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2018-004254-22
    A.3Full title of the trial
    Efficacy of Tofacitinib in Reduction of Inflammation Detected on MRI in Patients with Psoriatic ArthritiS PresenTing with Axial InvOlvement -
    a Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial (PASTOR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of Tofacitinib in Reduction of Spinal Inflammation Detected on MRI in Patients with Psoriatic ArthritiS
    A.4.1Sponsor's protocol code numberPASTOR2018
    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 SponsorCharite University
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Pharma GmbH, unrestricted grant
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharite University
    B.5.2Functional name of contact pointDr Fabian Proft
    B.5.3 Address:
    B.5.3.1Street AddressHindenburgdamm 30
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code12200
    B.5.3.4CountryGermany
    B.5.4Telephone number493084454837
    B.5.5Fax number493084454149
    B.5.6E-mailfabian.proft@charite.de
    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 Yes
    D.2.1.1.1Trade name Xeljanz 5 mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 CITRATE
    D.3.9.1CAS number 540737-29-9
    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 placeboTablet
    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
    Psoriatic Arthritis with axial (spinal) involvement
    E.1.1.1Medical condition in easily understood language
    Psoriatic Arthritis with Inflammation at the spine or sacroiliacal joints
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10037166
    E.1.2Term Psoriatic spondylitis
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Improvement of the total Berlin MRI score for sacroiliac joints and spine as compared to baseline after 12 weeks of therapy with Tofacitinib or placebo.
    E.2.2Secondary objectives of the trial
    Improvement of the total Berlin MRI score for SIJ and spine
    Improvement in ASAS, BASDAI, ASDAS-CRP
    Improvement of function (BASFI), axial mobility (BASMI, chest expansion), ASAS-Health Index, Health Assessment Questionnaire-Disability Index (HAQ-DI), patient global assessment on the NRS, physician global assessment on the NRS
    Improvement in C-reactive Protein
    Improvement in the Disease Activity Index for Psoriatic Arthritis (DAPSA), swollen joint count (SJC), tender joint count (TJC), enthesitis based on the MASES, dactylitis (count of dactylitic phalanges), PASI (Psoriasis Activity and Severity Index)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject ≥18 and <65 years of Age with written informed consent
    Diagnosis of PsA by their treating rheumatologist and subject fulfilling ClASsification criteria for Psoriatic ARtrhitis (CASPAR)
    Evidence of axial involvement (e.g. active inflammation, structural changes), that have been demonstrated by previous imaging techniques (e.g. X-ray, MRI, computed tomography).
    Presence of chronic (duration ≥3 months) back pain, BASDAI value of ≥4 and back pain score (BASDAI Question 2) of ≥4 (on a 0 – 10 Numeric Rating Scale-NRS) at screening and baseline.
    Presence of active inflammation (bone marrow edema) on screening MRI of the sacroiliac joints and/or spine according to the definition of Assessment of SpondyloArthritis international Society (ASAS) MRI working group (evaluated by central reader of screening MRI).
    History of an inadequate response to at least two different NSAIDs over a period of 4 weeks in total at the maximum recommended or tolerated doses or intolerance/contraindication for NSAIDs.
    Subjects of reproductive potential must use contraceptive methods.
    Subjects taking corticosteroids must be on an average daily dose of ≤10mg/day prednisone or equivalent for at least 14 days prior to the Baseline visit. Subjects taking Methotrexate (≤25mg /week) or Sulfasalazine (up to 3g/day) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 4 weeks before randomization.
    Subjects with previous biologic DMARDs will be allowed entry into study after appropriate wash-out periods as defined in protocol.
    E.4Principal exclusion criteria
    - significant acute or chronic infections including Tuberculosis, HBV/HCV/HIV and Herpes zoster as defined by protocol
    - pregnancy and breastfeeding
    - other chronic inflammatory articular disease (other than psoriasis or PsA)
    - treatments with DMARDs other than methotrexate or sulfasalazine (e.g. Leflunomide, Hydroxychloroquine or Apremilast) within 4 weeks prior to baseline (in case of Leflunomide either 8 weeks or 4 weeks with a standard cholestyramine wash-out).
    - Prior treatment with Tofacitinib or another JAK-inhibitor.
    - Current participation in another interventional study. If subjects participated in another study of any investigational drug, there must be an appropriate wash-out period prior to the Baseline Visit.
    - Actual malignancies or history of malignancies with curative treatment within 5 years prior to screening, except successfully treated non-metastatic squamous cell or basal cell carcinoma of the cutis or carcinoma in situ of the cervix
    - A subject with any condition possibly affecting oral drug absorption, e.g., gastrectomy...
    - Significant trauma or surgery procedure within 4 weeks prior to baseline, or any planned elective surgery during the study period.
    - Evidence of other severe uncontrolled gastrointestinal, hepatic (serum albumin <25 mg/l or Child-Pugh-Score >10), renal, pulmonary, cardiovascular, nervous or endocrine disorders.
    - Any subject who has been vaccinated with live or attenuated vaccines within the 4 weeks prior to the first dose of study medication or is to be vaccinated with these vaccines at any time during treatment or within 4 weeks after the last dose of study drug.
    - laboratory abnormalities as defined in protocol.
    - Patients who are defined as vulnerable patients according to Art. 10 REGULATION (EU) No 536/2014: patients who are institutionalized due to regulatory or juridical order; patients who are an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site; family members of the aforementioned employees or the investigator.
    - Patients with contraindications for the MRI including but not limited to: claustrophobia, seizure disorders, presence of an implanted electronic device (e.g., heart pacemaker, insulin pump, etc.) or metal implants not known to be MRI safe and metal foreign bodies in the patient’s body suspected to be ferromagnetic, tattoos performed with metal-containing paints or tattoos of large skin areas.
    E.5 End points
    E.5.1Primary end point(s)
    Improvement of the total Berlin MRI score for sacroiliac joints and spine as compared to baseline after 12 weeks of therapy with Tofacitinib or Placebo (see E.2.1 and E.2.2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12 compared to week 0
    E.5.2Secondary end point(s)
    see E.2.1 and E.2.2
    E.5.2.1Timepoint(s) of evaluation of this end point
    see E.2.1 and E.2.2
    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 No
    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) 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.8.2.4Number 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 concerned21
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    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
    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: 80
    F.1.3Elderly (>=65 years) No
    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 state80
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-14
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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