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    Summary
    EudraCT Number:2018-004539-54
    Sponsor's Protocol Code Number:TMP-0731-2018
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-10
    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 - PEI
    A.2EudraCT number2018-004539-54
    A.3Full title of the trial
    Capability of Tofacitinib or Etanercept to accelerate clinical relevant tapering of non-steroidal anti-inflammatory drugs and treat-to-target guided de-escalation of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy
    Überprüfung des Potentials von Tofacitinib oder Etanercept, die Dosisreduktion von Nicht-Steroidalen Antirheumatika und die Behandlungsziel-gesteuerte Deeskalation von Glukokortikosteroiden in Patienten mit aktiver Rheumatoider Arthritis und einem unzureichenden Ansprechen auf eine vorhergehende csDMARD-Therapie zu beschleunigen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Capability of Tofacitinib or Etanercept to accelerate clinical relevant dose reduction of non-steroidal anti-inflammatory drugs and treat-to-target guided minimization of intake of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy
    Überprüfung der Fähigkeit von Tofacitinib oder Etanercept, die Dosis von Nicht-Steroidalen Antirheumatika zu reduzieren und die Behandlungsziel-gesteuerte Verringerung der Einnahme von Glukokortikosteroiden bei Patienten mit aktiver Rheumatoider Arthritis und einem unzureichenden Ansprechen auf eine vorhergehende csDMARD-Therapie zu beschleunigen
    A.3.2Name or abbreviated title of the trial where available
    AcceleRAte
    A.4.1Sponsor's protocol code numberTMP-0731-2018
    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 SponsorFraunhofer Fraunhofer Gesellschaft for its Fraunhofer Institute for Molecular Biology and Applied Ecology IME
    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
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportFraunhofer Gesellschaft e.V.
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFraunhofer Institute for Molecular Biology and Applied Ecology IME
    B.5.2Functional name of contact pointBranch TMP - Clinical Research
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Stern-Kai 7
    B.5.3.2Town/ cityFrankfurt am Main
    B.5.3.3Post code60590
    B.5.3.4CountryGermany
    B.5.4Telephone number+4969630180208
    B.5.5Fax number+49241608550040
    B.5.6E-mailClinicalResearch@ime.fraunhofer.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
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.11 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 Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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: 3
    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 Celebrex
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Pharma PFE GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Capsule, hard
    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 active Rheumatoid Arthritis
    Patienten mit aktiver Rheumatoider Arthritis
    E.1.1.1Medical condition in easily understood language
    Patients with active Rheumatoid Arthritis
    Patienten mit aktiver Rheumatoider Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superiority in the proportion of patients who can discontinue Celecoxib treatment and in whom clinically relevant pain relief is measured, defined as reduction in VAS-pain (0-100 mm) of ≥ 30%, at week 12 compared to baseline in the TOFA group compared to the ETA group
    E.2.2Secondary objectives of the trial
    • To evaluate the mean dosage of Celecoxib at week 12
    • To evaluate the proportion of patients with discontinuation of CS-treatment at week 24
    • To evaluate the proportion of patients with achievement of LDA at week 24
    • To evaluate the proportion of patients who require rescue treatment at week 12
    • To evaluate the mean dosage of CS in the patients who achieve LDA at week 24 in the two treatment groups
    • To assess the mean dosage of CS at W24
    • To evaluate the number of patients with NSAID treatment at W24
    • To assess the proportion of patients who re-started NSAID treatment after W12 until W24
    • Assessment of the relative (%) and absolute pain relief (VAS 0-100 mm) compared to baseline
    • Analysis of the rate of flares (measured by FLARE questionnaire) between week 12 and week 24
    • To compare achievement of LDA (DAS28 (ESR) ≤3.2) and remission (DAS28 ≤ 2.6) using the DAS28 (ESR)
    • Assessment of disease activity measured by ACR20/50/70 response
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with active RA and an inadequate response to up to two previous csDMARD treatments (MTX, LEF, SSZ) with or without ongoing csDMARD therapy
    • RA according to ACR classification criteria
    • Age 18 – 65 years
    • Active RA is defined as
    o DAS28 > 3.2 and
    o TJC ≥ 3 and SJC  3
    • VAS-pain ≥ 60mm (0-100 mm)
    • Accompanying CS treatment for RA with a stable dosage of ≥ 2mg/d and  10 mg/d 2 weeks prior to BL (not more than 30% of patients without CS)
    • Accompanying need of NSAID or analgesic treatment due to arthritis and in dosages not exceeding the maximum dose according to SmPC
    • If ongoing csDMARD treatment, stable treatment will be defined as either
    o MTX treatment with a dosage of  10 mg/week and < 25 mg/week, continuously for at least 12 weeks prior to Screening (SCR) with a stable dose of MTX for at least 2 weeks prior to BL or
    o LEF treatment with a dosage between 10 to 20 mg/day, continuously for at least 12 weeks prior to SCR with a stable dose of LEF for at least 2 weeks prior to BL or
    o SSZ treatment with dosage between 1 to 3 g/day, continuously for at least 12 weeks prior to SCR with a stable dose of SSZ for at least 2 weeks prior to BL
    • Presence of documented negative results for testing of Hepatitis B and C
    • Written informed consent obtained prior to the initiation of any protocol-required procedures
    • Willingness to comply to study procedures and study protocol


    Inclusion criteria related to csDMARD treatment:
    For those patients without csDMARD treatment (MTX, LEF, SSZ) at study inclusion the following must be fulfilled:
    • MTX-treatment must be terminated for at least 12 weeks prior to BL
    • LEF must be terminated for at least 24 weeks prior to BL or its elimination will be forced as usual in daily clinical practice using Cholestyramin or activated carbon (according to SmPC of LEF)
    • SSZ must be terminated for at least 12 weeks prior to BL
    For those patients with ongoing csDMARD treatment (MTX, LEF, SSZ) at study inclusion the following must be fulfilled:
    o MTX, LEF or SSZ treatment continuously for at least 12 weeks prior to the Screening visit (with stable dose of MTX for at least 2 weeks prior to BL visit)
    E.4Principal exclusion criteria
    • Previous use of Tofacitinib or other JAK-inhibitors
    • Previous use of Etanercept
    • Previous use of any biological agent for RA
    o which was stopped due to lack of efficacy
    o one previous use of biological stopped due to intolerance will be allowed
    • CS treatment with dosages >10 mg at BL
    • Known hypersensitivity to any component of the study medication (TOFA, ETA, Celecoxib)
    • Previous use of Celecoxib as analgesic therapy which was stopped due to lack of efficacy or intolerance
    • Concomitant diseases with chronic pain syndrome or need of extended dosages or long-term treatment with the maximum dosages of NSAID/analgesics (according to SmPc) due to other concomitant diseases/pain symptoms in the discretion of the treating physician

    Exclusion criteria related to general health
    • Patients with other chronic inflammatory articular disease or systemic autoimmune disease
    • Patients with active Tb (Evaluation according to local standards in clinical routine care)
    • Patients with latent Tb, that are not pre-treated for at least 1 month and planned to be treated 9 months in total with Isozid once a day
    • Any active infection, a history of recurrent clinically significant infections (e.g. HIV) or a history of recurrent bacterial infections with encapsulated organisms
    • Primary or secondary immunodeficiency
    • History of cancer with curative treatment not longer than 5 years ago except basal-cell carcinoma of the skin that had been excised
    • Evidence of significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient’s safety and with the study outcome
    • History of a severe psychological illness or condition
    • Known hypersensitivity to sulfonamides
    • Active peptic ulceration or gastrointestinal (GI) bleeding
    • Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid (aspirin) or other NSAIDs including COX-2 Inhibitors
    • Risk for or history of thrombotic events (e.g. pulmonary embolism or thrombosis)
    • Severe hepatic dysfunction (serum albumin < 25 g/L or Child-Pugh score ≥ 10)
    • Patients with estimated creatinine clearance < 30 mL/min
    • Inflammatory bowel disease
    • Congestive heart failure (NYHA II-IV)
    • Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
    • Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test
    • Males or females of reproductive potential not willing to use effective contraception (e.g. contraceptive pill, IUD, physical barrier)
    • Alcohol, drug or chemical abuse

    Exclusion criteria related to prior treatments
    • Current participation in another interventional clinical trial or participation within the last 90 days

    Exclusion criteria related to formal aspects
    • Underage or incapable patients
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients who can discontinue Celecoxib treatment and in whom clinically relevant improvement in pain levels are measured, defined as reduction in VAS pain of ≥ 30% at week 12 compared to BL
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint will be analysed after 12 weeks (visit 6)
    E.5.2Secondary end point(s)
    Assessments at all available visits comparing both treatment groups and compared to BL:
    • Mean dosage of Celecoxib in patients at week 12
    • Proportion of patients with discontinuation of CS-treatment at week 24
    • Proportion of patients who require rescue treatment at week 12
    • Mean dosage of CS in the patients who achieve LDA at week 24 in the two treatment groups
    • Mean dosage of CS at W24
    • Number of patients with NSAID treatment at W24
    • Proportion of patients who re-started NSAID treatment after W12 until W24
    • Absolute and relative (%) pain levels (VAS 0-100 mm)
    • Change in pain levels (VAS 0-100 mm) compared to BL
    • Determination of flares (measured by FLARE questionnaire) between week 12 and week 24
    • Proportion of patients who achieve LDA (DAS28 (ESR) ≤ 3.2) and DAS-remission (DAS28 ≤ 2.6)
    • Proportion of patients who achieve ACR20/50/70 response incl. changes in ACR core set (SJC, TJC, HAQ, patient’s and physician’s global assessment, pain CRP or ESR)
    • DAS28 (ESR), SJC (66), TJC (68) change compared to BL
    • Quality of Life: SF36 and HAQ-DI scores and change to BL
    • Correlation of SF36 and HAQ-DI results
    • Treatment satisfaction: TSQM-14 scores
    • Patient’s expectation on treatment
    • Correlation of TSQM-14 results and patient’s expectation on treatment
    • Evaluation of results of treatment adherence (drug accountability)

    Optional scientific accompanying program:
    • Collection of biomaterial samples (EDTA, Serum, Stool) for later genome, cell and biomarker analysis
    • Correlation of pain characteristics measured by QST (selected sites only), VAS pain and pain relief at BL, week 4, 12 and 24

    Safety parameters:
    • Type, frequency and seriousness of adverse events (AEs)
    • Incidence rates of serious infection events (SIEs), SAEs
    • Lab abnormalities
    E.5.2.1Timepoint(s) of evaluation of this end point
    Statistical analysis will be performed after termination of the study, when the data review process of the data management is completed and all queries have been resolved.
    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 No
    E.6.5Efficacy No
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned28
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    End of Trial will be after close-out visit at last study site.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 180
    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 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 state192
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 192
    F.4.2.2In the whole clinical trial 192
    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 Decision2019-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-03
    P. End of Trial
    P.End of Trial StatusOngoing
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