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    Clinical Trial Results:
    NOT CONTROLLED STUDY TO ASSESS THE EFFICACY OF TOCILIZUMAB IN PATIENTS WITH MODERATE OR SEVERE RHEUMATOID ARTHRITIS WHO ARE CANDIDATES TO BE TREATED WITH A BIOLOGICAL THERAPY AS MONOTHERAPY

    Summary
    EudraCT number
    		 2013-004051-20
    Trial protocol
    		 ES  
    Global end of trial date
    09 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jan 2019
    First version publication date
    19 Jan 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FER-TOC-2013-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02087696
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Spanish Foundation of Rhematology
    Sponsor organisation address
    Calle Marques del Duero n5, Madrid, Spain, 28001
    Public contact
    MARIA AUXILIADORA MARTIN MARTINEZ, FUNDACIÓN ESPAÑOLA DE REUMATOLOGÍA, +34 915767799273, mauxiliadora.martin@ser.es
    Scientific contact
    MARIA AUXILIADORA MARTIN MARTINEZ, FUNDACIÓN ESPAÑOLA DE REUMATOLOGÍA, +34 915767799273, mauxiliadora.martin@ser.es
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Apr 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of TCZ given as monotherapy in RA patients with active disease, in terms of rate of patients reaching good or moderate EULAR response, at week 24.
    Protection of trial subjects
    No specific measures were applied to protect trial subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jun 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 93
    Worldwide total number of subjects
    93
    EEA total number of subjects
    93
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    76
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Six patients (two without prior treatment with biologic agents, and four with prior biologic treatment) will be recruited consecutively, once it has been verified that the patient meets the selection criteria, until the sample size is reached. At two centers, seven patients meeting the criteria selection will be recruited.

    Pre-assignment
    Screening details
    		 Not Applicable

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Naive biological treatment
    Arm description
    		 Rheumatoid arthritis patients with intolerance or poor compliance or contraindication to methotrexate and who have not received previous biological treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Roactemra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    8 mg/kg administered every 4 weeks for 24 weeks

    Arm title
    		 Previous biological treatment
    Arm description
    		 Rhematoid arthirtis patients with intolerance or poor compliance or contraindication to methotrexate and who have not
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Naive biological treatment Previous biological treatment
    Started
    50
    43
    Completed
    34
    25
    Not completed
    16
    18
         Other reasons not included in the study
    2
    2
         Consent withdrawn by subject
    2
    3
         Adverse event, non-fatal
    5
    4
         Lost to follow-up
    1
    2
         Protocol deviation
    1
    1
         Lack of efficacy
    5
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Naive biological treatment
    Reporting group description
    		 Rheumatoid arthritis patients with intolerance or poor compliance or contraindication to methotrexate and who have not received previous biological treatment.

    Reporting group title
    Previous biological treatment
    Reporting group description
    		 Rhematoid arthirtis patients with intolerance or poor compliance or contraindication to methotrexate and who have not

    Reporting group values
    		 Naive biological treatment Previous biological treatment Total
    Number of subjects
    		 50 43 93
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.5 ± 12.4 57.9 ± 12.5 -
    Gender categorical
    Units: Subjects
        Female
    		 8 6 14
        Male
    		 42 37 79
    Number of previous DMARDs
    Number of previous DMARDs
    Units: Subjects
        0 DMARDs
    		 2 0 2
        1 DMARDs
    		 8 7 15
        >1 DMARDs
    		 36 31 67
        No data
    		 4 5 9
    Contraindication to methotrexate
    Units: Subjects
        YES
    		 1 3 4
        NO
    		 49 40 89
    Lack of adhesion of methotrexate
    Units: Subjects
        YES
    		 1 0 1
        NO
    		 49 43 92
    Intolerance of methotrexate
    Units: Subjects
        YES
    		 44 33 77
        NO
    		 6 10 16
    Hypertension
    Units: Subjects
        YES
    		 12 17 29
        NO
    		 38 26 64
    Mellitus diabetes
    Units: Subjects
        YES
    		 3 3 6
        NO
    		 47 40 87
    Dyslipidemia
    Units: Subjects
        YES
    		 6 13 19
        NO
    		 44 30 74
    Solid Tumor
    Units: Subjects
        YES
    		 1 0 1
        NO
    		 49 43 92
    Cerebrovascular accident
    Units: Subjects
        YES
    		 1 2 3
        NO
    		 49 41 90
    Lung disease
    Units: Subjects
        YES
    		 0 3 3
        NO
    		 50 40 90
    Chronic renal failure
    Units: Subjects
        YES
    		 1 4 5
        NO
    		 49 39 88
    Extra-articular manifestations
    Units: Subjects
        YES
    		 4 5 9
        NO
    		 46 38 84
    NSAID
    Nonsteroidal anti-inflammatory drug
    Units: Subjects
        YES
    		 23 22 45
        NO
    		 27 21 48
    Corticosteroids
    Units: Subjects
        YES
    		 34 32 66
        NO
    		 16 11 27
    Disease duration
    Disease duration
    Units: years
        arithmetic mean (standard deviation)
    		 6.4 ± 6.6 13.3 ± 11.5 -
    DAS28-erythrocyte sedimentation rate
    Units: Disease activation score
        arithmetic mean (standard deviation)
    		 5.6 ± 1.2 5.5 ± 1.1 -
    Clinical Disease Activity Index
    CDAI
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 29.1 ± 10 31 ± 12 -
    Simple Disease Activity Index
    SDAI
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 34.3 ± 17 38.5 ± 17.1 -
    Short Form-36
    SF-36
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 90.3 ± 6.8 91.2 ± 6.9 -
    FACIT-F
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 23.6 ± 10.3 25.6 ± 9 -
    C-reactive protein CRP
    Units: mg/L
        arithmetic mean (standard deviation)
    		 13.6 ± 20.7 12.8 ± 11.5 -
    ESR
    Erythrocite sedimentation rate
    Units: mm/h
        arithmetic mean (standard deviation)
    		 27.9 ± 27 40.3 ± 30.6 -
    Number of tender joints
    Units: joints
        arithmetic mean (standard deviation)
    		 9.7 ± 6.0 9.9 ± 5.7 -
    Number of swollen joints
    Units: joints
        arithmetic mean (standard deviation)
    		 5.8 ± 3.1 6.3 ± 4.4 -
    Health Assessment Questionnaire
    HAQ
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 1.7 ± 0.7 1.8 ± 0.6 -
    Visual Analogue scale of the patient
    VAS of the patient
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 7.4 ± 1.6 6.9 ± 1.9 -
    Visual analogue scale of the physician
    VAS of the Physician
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 6.7 ± 1.2 6.6 ± 1.4 -
    VAS Pain
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 7.4 ± 1.7 6.8 ± 1.9 -
    Body Mass Index
    Units: Kg/m2
        arithmetic mean (standard deviation)
    		 26 ± 5 28.1 ± 5.5 -

    End points

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    End points reporting groups
    Reporting group title
    Naive biological treatment
    Reporting group description
    		 Rheumatoid arthritis patients with intolerance or poor compliance or contraindication to methotrexate and who have not received previous biological treatment.

    Reporting group title
    Previous biological treatment
    Reporting group description
    		 Rhematoid arthirtis patients with intolerance or poor compliance or contraindication to methotrexate and who have not

    Primary: Percentage patients achieving good or moderate European League Against Rheumatism Response

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    End point title
    		 Percentage patients achieving good or moderate European League Against Rheumatism Response
    End point description
    End point type
    Primary
    End point timeframe
    Week 0 to week 24
    End point values
    		 Naive biological treatment Previous biological treatment
    Number of subjects analysed
    44
    36
    Units: Patients
        Good response EULAR
    1
    0
        Moderate response EULAR
    41
    33
    Statistical analysis title
    		 Patients Achieving good or moderate EULAR response
    Comparison groups
    Previous biological treatment v Naive biological treatment
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.528
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Percentage of patients complying American College of Rheumatology (ACR) criteria

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    End point title
    		 Percentage of patients complying American College of Rheumatology (ACR) criteria
    End point description
    End point type
    Secondary
    End point timeframe
    At 24 weeks of treatment
    End point values
    		 Naive biological treatment Previous biological treatment
    Number of subjects analysed
    44
    36
    Units: Patients
        ACR 20 response
    26
    23
        ACR 50 response
    22
    14
        ACR 70 response
    7
    3
    Statistical analysis title
    		 Percentage of patients complying ACR criteria
    Comparison groups
    Previous biological treatment v Naive biological treatment
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.661
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All the patients were offered open-label treatment with 8 mg/kg every 4 weeks for 6 months between may 2014 and april 2017
    Adverse event reporting additional description
    Adverse effects for all patients who have received at least one dose of tociluzumab
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Patients have received al least one dose
    Reporting group description
    		 Patients have received al least one dose of tocilizumab

    Serious adverse events
    		 Patients have received al least one dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 93 (6.45%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Myelopathy
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    spine stenosis
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Aborted pregnancy
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Paresis of vocal cords
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Rash
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Type IV hypersensitivity reaction
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Colonic abscess
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Syncope
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Joint swelling
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Patients have received al least one dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 93 (49.46%)
    Vascular disorders
    Hemorrhoids
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Systolic hypertension
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Surgical and medical procedures
    Skin biopsy
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    General disorders and administration site conditions
    Feeling tightness in the throat
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Odinophagy
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Sickness
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Worsening of the disease
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Immune system disorders
    Erythema
         subjects affected / exposed
    5 / 93 (5.38%)
         occurrences all number
    5
    erythema in application area
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Acute bronchitis
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Faringoamigdalitis
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Laryngitis
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Sinus Catarrh
         subjects affected / exposed
    3 / 93 (3.23%)
         occurrences all number
    3
    Product issues
    Anaphylactic reaction
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Fixed Rash
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Traumatic limb injury
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Cardiac disorders
    Atrial tachycardia
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Nervous system disorders
    Facial paralysis
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Epistaxis
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Leukopenia
         subjects affected / exposed
    3 / 93 (3.23%)
         occurrences all number
    3
    Neutropenia
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Detachment of the vitrious body
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 93 (2.15%)
         occurrences all number
    2
    Gastric reflux
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Gastritis
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Viral gastroenteritis
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Boil
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Cutaneous reaction
         subjects affected / exposed
    2 / 93 (2.15%)
         occurrences all number
    2
    Dermatophytosis
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Dry mucus
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Local reaction
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Papular eruption
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Renal and urinary disorders
    Cystitis
         subjects affected / exposed
    2 / 93 (2.15%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Lumbar hernia
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Lumbar radiculopathy
         subjects affected / exposed
    2 / 93 (2.15%)
         occurrences all number
    2
    Muscular contracture
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Tendinitis
         subjects affected / exposed
    2 / 93 (2.15%)
         occurrences all number
    2
    Infections and infestations
    cutaneous infection
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Herpes simplex
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Infection of the lower respiratory tract
         subjects affected / exposed
    2 / 93 (2.15%)
         occurrences all number
    2
    Infection with human papillomavirus
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Lung infection
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Dyslipidemia
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Elevated transaminases
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    High Blood cholesterol
         subjects affected / exposed
    4 / 93 (4.30%)
         occurrences all number
    4
    High triglycerides in blood
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1
    Hyperlipidaemia
         subjects affected / exposed
    1 / 93 (1.08%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    We ara unable to reach the programmed recruitment of 122 patients, although the time of recruitment was prolonged for 18 additional months.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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