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    Summary
    EudraCT Number:2010-019694-15
    Sponsor's Protocol Code Number:ML25252
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-07-28
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-019694-15
    A.3Full title of the trial
    Act-Alone : An open-label, single-arm study to describe glucocorticoid use in rheumatoid arthritis patients treated with Tocilizumab in daily clinical practice and to evaluate systematic glucocorticoid dose reduction once low disease activity is reached
    A.3.2Name or abbreviated title of the trial where available
    ACT-Alone
    A.4.1Sponsor's protocol code numberML25252
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorN.V. Roche S.A.
    B.1.3.4CountryBelgium
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Medrol 4 mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer S.A.
    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 Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 83-43-2
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name Medrol A 16 mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer S.A.
    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 Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 83-43-2
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Rheumatoid Arthritis in adult
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    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
    Non-interventional phase: description of GC use in RA patients treated with Tocilizumab (TCZ) in daily clinical practice

    Intreventional phase : proportion of RA patients in low disease activity (LDA) able to discontinue oral GC within 20 weeks and at the latest at Visit 8, confirmed at the consecutive visit (Consolidation visit) without loss of clinical response defined as DAS28 (CRP) > 3.2
    E.2.2Secondary objectives of the trial
    Non-interventional phase:
    - Proportion of patients able to reach LDA, defined as DAS28 ≤ 3.2 and remission defined as DAS28 < 2.6in patients receiving oral GC on background TCZ treatment
    - Description of the management of RA patients treated with GC and TCZ
    - Change in mean HAQ from Visit 1 to Visit 2
    Interventional phase:
    - Proportion of RA patients able to start the step down scheme for GC (Visit 3), reduce oral GC (≥ 50% reduction) at Visit 9, discontinue GC only by Visit 9
    - Mean time-averaged GC dose change from Visit 3 till Visit 9
    - Change in mean HAQ, physicians global assessment, VAS pain, FACIT-Fatigue, SF36 from Visit 3 to Consolidation Visit
    - Change in mean different SF36 sub domain scores from Visit 3 to Consolidation Visit
    - Assessment of the safety of all administered treatments
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Non-interventional phase :
    - Male or non pregnant, non-nursing female
    - ≥ 18 years of age
    - Diagnosis of moderate to severe active RA defined as DAS28 ≥ 3.7
    - Patients with inadequate clinical response to a current treatment with ≥ 2 non-biologic DMARDs, 1 of them being MTX optimally administered during a period of ≥ 3 months OR patients with inadequate clinical response to anti-TNF therapy
    - Start TCZ according to SmPC at Visit 1 as per the physician’s discretion
    - Combination therapy with MTX or without MTX in case of intolerability to MTX or where continued treatment with MTX is inappropriate
    - Receiving treatment on an outpatient basis
    - Current use of an oral GC started at least 4 weeks prior to Visit 1
    - Absence of evolutive tuberculosis, demonstrated by a negative Mantoux-test (PPD) and a negative chest X-ray. A patient diagnosed with latent TB should be treated with standard prophylactic antimycobacterial TB therapy for at least 4 weeks before initiating the biologic
    - Patients able and willing to give written informed consent and comply with the requirements of the study protocol (non-interventional & interventional phase)

    Interventional phase:
    - Patients enrolled in the non-interventional phase
    - Patients in LDA defined as DAS28 score ≤ 3.2 at Visit 2
    - Oral GC use with methylprednisolone equivalent dose of ≥ 1 mg and ≤ 20 mg/day at Visit 2
    E.4Principal exclusion criteria
    For both phases :
    - Rheumatic autoimmune disease other than RA, incl. systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis or significant systemic involvement secondary to RA (e.g. vasculitis, pulmonary fibrosis or Felty's syndrome). Patients with interstitial pulmonary fibrosis and still able to tolerate MTX therapy are permitted. Sjögren's syndrome with RA or nodulosis is permitted
    - Functional class IV as defined by the ACR Classification of Functional Status in RA (largely or wholly incapacitated with patient bedridden or confided to wheel chair, permitting little or no self-care)
    - Prior history of or current inflammatory joint disease other than RA (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)
    - Females of child-bearing potential who are not using a reliable means of contraception, e.g. physical barrier (patient and partner), contraceptive pill or patch, spermicide and barrier, or IUD
    - Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) prior to Visit 1
    - Immunization with a live/attenuated vaccine within 4 weeks prior to Visit 1
    - Treatment with opioids within 1 week prior to Visit 1 of the trial
    - Evidence of serious uncontrolled concomitant cardiovascular, nervous system (like myasthenia gravis), psychiatric, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus, osteoporosis) or gastrointestinal disease (ulcus pepticum)
    - Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
    - Patients with a history of diverticulitis or diverticulosis requiring antibiotic treatment or chronic ulcerative lower gastro-intestinal (GI) disease such as Crohn's disease, ulcerative colitis or recent bowel anastomosis or other symptomatic lower GI conditions that might predispose to perforations
    - Known active current infection or history of recurrent bacterial, viral, fungal, mycobacterial or other infections including but not limited to TB
    - Any major episode of infection requiring hospitalization or treatment with IV antibiotics and/or GC 4 weeks before start or oral antibiotics and/or GC within 2 weeks prior to Visit 1
    - Patients with active TB are excluded when treatment was required within the previous 3 years
    - History of alcohol, drug or chemical abuse within the 6 months prior to Visit 1
    E.5 End points
    E.5.1Primary end point(s)
    Non-interventional phase
    - Measures of GC treatment: GC type(s), GC start dose (Visit 1) and GC end dose (Visit 2), total cumulative dose (in methylprednisolone equivalent) and changes in dosage
    - Dose and dose changes in TCZ and other RA medications
    - Prognostic parameters: RF, anti-CCP antibodies and erosions
    - Disease activity measures: Baseline, mean and delta DAS28, baseline, mean and delta HAQ
    - Time interval between Visit 1 and Visit 2
    - RA patients able to qualify for inclusion in the interventional phase, described as obtaining LDA defined as DAS28 ≤ 3.2 and oral GC intake with methylprednisolone equivalent dose of ≥ 1 mg and ≤ 20 mg/day at Visit 2
    - RA patients able to reach remission defined as DAS28 < 2.6

    Interventional phase:
    - RA patient able to start the step down scheme for GC per protocol (Visit 3)
    - RA patient in LDA able to discontinue oral GC within 20 weeks and at the latest at Visit 8, confirmed at the consecutive visit (Consolidation Visit) without loss of clinical response defined as DAS28 (CRP) > 3.2
    - RA patient able to reduce oral GC (≥ 50% reduction) at Visit 9 (week 24)
    - Time-averaged GC dose change from Visit 3 till Visit 9 (AUC method)
    - Change in physicians global assessment from Visit 3 to Consolidation Visit
    - Change in HAQ from Visit 3 to Consolidation Visit
    - Change in FACIT-Fatigue from Visit 3 to Consolidation Visit
    - Change in VAS pain from Visit 3 to Consolidation Visit
    - Change in SF36 mental and physical component score from Visit 3 to Consolidation Visit
    - Change in different SF36 sub domain scores from Visit 3 to Consolidation Visit
    - RA patients able to discontinue GC only by Visit 9 (week 24)

    Sub analyses will look at patients entering the GC dose reduction phase in DAS28 remission, with LDA, on TCZ monotherapy, those patients able to discontinue GC prior to Visit 8 (Week 20) and RA patients without GC vs those who still require GC by Visit 9.

    Safety endpoints

    - In all included patients (non-interventional and interventional phase):
     Incidence of AEs and SAEs
     Incidence of infections and serious infections

    - In patients included in the interventional phase:
     Patients experiencing a loss of clinical response defined as DAS28 (CRP) > 3.2 during application of GC dose reduction schedule
     Change of CRP from Visit 3 till Consolidation Visit
     Increase in swollen joint count (SJC) to 3 or more from Visit 3 till Consolidation Visit
     Increase in HAQ of ~ 0.15 from Visit 3 till Consolidation Visit
     Worsening of FACIT-fatigue scores by 50% from Visit 3 till Consolidation Visit
     Glucose tolerance changes: fasting glucose and HbA1c (assessment at Visit 3 and Consolidation Visit)
     Differences in lipids: Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides (assessment at Visit 3 and Consolidation Visit – patients taking lipid lowering medication and in patients not taking lipid lowering medication)
     In RA patients without GC vs those who still require GC at Visit 9 (week 24):
    o Incidence of infection/serious infection
    o Glucose tolerance changes
    o Differences in lipids
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned17
    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 Information not present in EudraCT
    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
    Lats patient Last visit
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state240
    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 Decision2010-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-05
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