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    Summary
    EudraCT Number:2019-004179-38
    Sponsor's Protocol Code Number:PULMORA
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-11-19
    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 ConcernedSweden - MPA
    A.2EudraCT number2019-004179-38
    A.3Full title of the trial
    Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis
    Effekter av tofacitinib jämfört med metotrexate på kliniska och molekylära markörer för sjukdomsaktivitet i leder och lungor vid tidig reumatoid artrit
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis
    Effekt av tofacitinib (Xeljanz®) jämfört med metotrexat på sjukdomsaktivitet i leder och lungor vid tidig ledgångsreumatism.
    A.3.2Name or abbreviated title of the trial where available
    PULMORA
    A.4.1Sponsor's protocol code numberPULMORA
    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 SponsorVästra Götalandsregionen
    B.1.3.4CountrySweden
    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 supportVästra Götalandsregionen-Sahlgrenska University Hospital
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVästra Götalandsregionen
    B.5.2Functional name of contact pointCRRC-SU monitored mailbox
    B.5.3 Address:
    B.5.3.1Street AddressClinical Rheumatology Research Center, Sahlgrenska University Hospital, Gröna stråket 16, 7 tr
    B.5.3.2Town/ cityGöteborg
    B.5.3.3Post code41345
    B.5.3.4CountrySweden
    B.5.4Telephone number00460700 20 65 77
    B.5.6E-mailkoordinator.reuma@vgregion.se
    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
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 RoleComparator
    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 Metotrexat Orion
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with early active rheumatoid arthritis
    E.1.1.1Medical condition in easily understood language
    Patients with early active rheumatoid arthritis
    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 HLT
    E.1.2Classification code 10039075
    E.1.2Term Rheumatoid arthritis and associated conditions
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Effect of tofacitinib compared to that of methotrexate on interstitial pulmonary abnormalities at 24 weeks.
    E.2.2Secondary objectives of the trial
    Effects of tofacitinib vs methotrexate on; pulmonary abnormalities by HRCT total score at 48 weeks and by pattern category at 24 and 48 weeks, pulmonary function by spirometry and diffusion capacity at 24 and 48 weeks, RA disease activity (joint counts and ESR/CRP) at 12, 24 and 48 weeks and remission at 24 and 48 weeks, radiographic progression extremities at 24 and 48 weeks, patient reported outcomes on disease activity and pulmonary symptoms at 24 and 48 weeks, safety and tolerability.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study: Explore the molecular determinants of disease activity in the lungs and joints of the main study subjects before and after treatment.

    This optional sub-study is described in the PULMORA protocol.

    Exploratory objectives: To investigate the cellular and molecular profiles of bronchoalveolar lavage fluid, synovial fluid and tissue samples of the patients in the PULMORA trial, so as to identify potential biomarkers for diagnosis, prognosis, and the responses to treatment of ILD.
    E.3Principal inclusion criteria
    1. Diagnosis of seropositive (i.e., presence of RF and/or anti-CCP antibodies) RA according to the ACR/EULAR 2010 criteria within 24 months.
    2. No previous treatment with DMARDs. History of prednisone use is allowed but should have been discontinued 2 weeks before baseline measurement.
    3. Active disease with ≥2 painful and ≥2 swollen joints in 66/68 joints and CRP ≥2.0 mg/dl
    4. Aged 18–80 years
    5. Willing to undergo HRCT and PFTs
    E.4Principal exclusion criteria
    1. Current active inflammatory joint disease other than RA.
    2. Significant and/or uncontrolled cardiac, pulmonary disease, nervous system, renal, hepatic, endocrine or gastrointestinal disorders or severe RA which, in the investigator’s opinion, would preclude patient participation.
    3. Malignancy within the past 5 years, except for successfully treated cervical carcinoma in situ, basal cell and squamous cell carcinoma of the skin, with no evidence of recurrence or metastatic disease for at least 3 years.
    4. Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection.
    5. Active infection (excluding fungal infections of nail beds) requiring i.v. anti-infectives within 4 weeks, or oral anti-infectives within 2 weeks prior to baseline.
    6. Pregnant or lactating women. Serum human chorionic gonadotropin will be measured prior to the first dosing of study drugs.
    7. Positive tests for hepatitis B (HBsAg or HBV DNA) or hepatitis C serology.
    8. History of herpes zoster infection during last 10 years.
    9. History of venous thromboembolism or diverticulitis.
    10. Positive tuberculosis history and/or positive Quantiferon test.
    11. Hemoglobin <90 g/L.
    12. Absolute neutrophil count (ANC) <1.5  103/L.
    13. ASAT or ALAT >2.0 times the upper limit of normal.
    E.5 End points
    E.5.1Primary end point(s)
    Effects of tofacitinib compared to effects of methotrexate on mean change in total interstitial disease score of pulmonary abnormalities by HRCT at 24 weeks compared to baseline.

    The score is a total sum of the extent (percentage ration of pattern area to total lung area) of abnormalities by category (reticulations, ground-glass, honey-combing, consolidations and emphysema) at six different levels of the lungs. It is a quantitative score but the pattern definition and borders are determined by two independent bilded assessors.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 24 weeks.
    E.5.2Secondary end point(s)
    Effects of tofacitinib compared to effects of methotrexate on:
    • Pulmonary abnormalities on HRCT at 48 weeks (total interstitial disease score) and by category at 24 and 48* weeks
    • Pulmonary function at 24 and 48* weeks
    • Patient-reported outcomes on disease symptoms at 24 and 48* weeks
    • RA disease activity at 12, 24 and 48* weeks
    • RA remission at 24 and 48* weeks
    • Erosivity at 24 and 48* weeks
    • Safety and tolerability every 2-4 weeks
    E.5.2.1Timepoint(s) of evaluation of this end point
    Effects of tofacitinib compared to effects of methotrexate on:
    • Pulmonary abnormalities on HRCT by category at 24 and 48* weeks
    • Pulmonary function at 24 and 48* weeks
    • Patient-reported outcomes on disease symptoms at 24 and 48* weeks
    • RA disease activity at 12, 24 and 48* weeks
    • RA remission at 24 and 48* weeks
    • Erosivity at 24 and 48* weeks
    • Safety and tolerability every 2-4 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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 Yes
    E.8.1.7.1Other trial design description
    assessor-blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.3.1Comparator description
    methotrexate
    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 concerned3
    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 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 years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state145
    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)
    After end-of-trial, the patients will continue at the out-patient clinic and receive standard-of-care according to National Guidelines for the management and treatment of RA.
    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 Decision2020-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2024-02-01
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