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    Clinical Trial Results:
    An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab(Remicade or CT-P13) in Study CT-P13 3.1

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines
    Summary
    EudraCT number
    		 2011-004468-31
    Trial protocol
    		 GB   AT   ES   LV   SK   LT   PL   IT  
    Global end of trial date
    12 Jul 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2017
    First version publication date
    01 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CT-P13 3.2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CELLTRION, Inc.
    Sponsor organisation address
    23, Academy-ro, Yeonsu-gu, Incheon, Korea, Republic of,
    Public contact
    SuEun Song, CELLTRION, Inc, SuEun.Song@celltrion.com
    Scientific contact
    Sung Young Lee, CELLTRION, Inc, SungYoung.Lee@celltrion.com
    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
    10 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jul 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jul 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To confirm long-term efficacy and safety of CT-P13.
    Protection of trial subjects
    - Hypersensitivity monitoring was performed as following. • Vital sign: 15 minutes [±5 minutes] before beginning the infusion, at the start of infusion, every 30 minutes [±5 minutes] after the start of infusion, at the end of infusion, and 30, 60, and 120 minutes [±10 minutes] after the end of infusion. - Throughout the study, patients were monitored for the clinical signs and symptoms of TB. • Premedications were given for safety of patients • Emergency equipment and medication were available. • For patients who experienced or developed life-threatening infusion-related anaphylactic reactions, infliximab treatment was stopped immediately and the patient withdrawn from the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Feb 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 4
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Ukraine: 38
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 12
    Country: Number of subjects enrolled
    Bulgaria: 19
    Country: Number of subjects enrolled
    Chile: 15
    Country: Number of subjects enrolled
    Colombia: 12
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Latvia: 9
    Country: Number of subjects enrolled
    Lithuania: 18
    Country: Number of subjects enrolled
    Mexico: 28
    Country: Number of subjects enrolled
    Peru: 11
    Country: Number of subjects enrolled
    Philippines: 27
    Country: Number of subjects enrolled
    Poland: 86
    Country: Number of subjects enrolled
    Romania: 10
    Worldwide total number of subjects
    302
    EEA total number of subjects
    159
    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)
    289
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Male or female patients with rheumatoid arthritis (aged 18 to 75 years old based on Study CT-P13 3.1) who had completed the scheduled visits, including the EOS Visit, in Study CT-P13 3.1

    Period 1
    Period 1 title
    Phase III (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Maintenance
    Arm description
    		 maintain treatment with CT-P13 in Study CT-P13 3.2 (Safety population)
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT-P13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    CT-P13 (3 mg/kg, IV infusion for 2hr per dose) coadministered MTX between 12.5 to 25 mg/week (oral or parenteral dose) and folic acid (≥5 mg/week, oral dose)

    Arm title
    		 Switch
    Arm description
    		 switch from Remicade reference product in Study CT-P13 3.1 to CT-P13 in Study CT-P13 3.2 (Safety population)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    CT-P13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    CT-P13 (3 mg/kg, IV infusion for 2hr per dose) coadministered MTX between 12.5 to 25 mg/week (oral or parenteral dose) and folic acid (≥5 mg/week, oral dose)

    Number of subjects in period 1
    		Maintenance Switch
    Started
    159
    143
    Completed
    134
    127
    Not completed
    25
    16
         Consent withdrawn by subject
    4
    5
         Physician decision
    1
    -
         death
    1
    -
         Adverse event, non-fatal
    16
    8
         Lost to follow-up
    2
    2
         Lack of efficacy
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Maintenance
    Reporting group description
    		 maintain treatment with CT-P13 in Study CT-P13 3.2 (Safety population)

    Reporting group title
    Switch
    Reporting group description
    		 switch from Remicade reference product in Study CT-P13 3.1 to CT-P13 in Study CT-P13 3.2 (Safety population)

    Reporting group values
    		 Maintenance Switch Total
    Number of subjects
    		 159 143 302
    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
        median (full range (min-max))
    		 50 (18 to 73) 49 (23 to 74) -
    Gender categorical
    Units: Subjects
        Female
    		 126 121 247
        Male
    		 33 22 55

    End points

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    End points reporting groups
    Reporting group title
    Maintenance
    Reporting group description
    		 maintain treatment with CT-P13 in Study CT-P13 3.2 (Safety population)

    Reporting group title
    Switch
    Reporting group description
    		 switch from Remicade reference product in Study CT-P13 3.1 to CT-P13 in Study CT-P13 3.2 (Safety population)

    Subject analysis set title
    Intent-to-Treat Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects enrolled in Study CT-P13 3.2 were included in Intent-to-Treat Subjects.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects who received a complete or partial dose of IMP were included in the Safety Analysis Set.

    Subject analysis set title
    Efficacy Population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects who received at least 1 full dose of IMP and had data for at least 1 efficacy assessment were included in the Efficacy Analysis Set.

    Primary: Treatment-Emergent Serious Adverse Events

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    End point title
    		 Treatment-Emergent Serious Adverse Events [1]
    End point description
    Number of Patients with at least one Treatment Emergent Serious Adverse Event
    End point type
    Primary
    End point timeframe
    up to EOS
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The End Points such as Treatment-Emergent Serious Adverse Events, Treatment-Emergent Adverse Events, Treatment-Emergent Adverse Events due to infection, Hypersensitivity and infusion-related reactions were described using descriptive statistics.
    End point values
    		 Maintenance Switch
    Number of subjects analysed
    159 [2]
    143 [3]
    Units: percentage
        number (not applicable)
    7.5
    9.1
    Notes
    [2] - Safety population
    [3] - Safety population
    No statistical analyses for this end point

    Primary: Hypersensitivity and infusion-related reactions

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    End point title
    		 Hypersensitivity and infusion-related reactions [4]
    End point description
    Number of patients with at least one Treatment Emergent Adverse Event due to hypersensitivity and infusion-related reactions
    End point type
    Primary
    End point timeframe
    up to EOS
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The End Points such as Treatment-Emergent Serious Adverse Events, Treatment-Emergent Adverse Events, Treatment-Emergent Adverse Events due to infection, Hypersensitivity and infusion-related reactions were described using descriptive statistics.
    End point values
    		 Maintenance Switch
    Number of subjects analysed
    159 [5]
    143 [6]
    Units: percentage
        number (not applicable)
    6.3
    2.8
    Notes
    [5] - Safety population
    [6] - Safety population
    No statistical analyses for this end point

    Primary: Treatment-Emergent Adverse Events

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    End point title
    		 Treatment-Emergent Adverse Events [7]
    End point description
    Number of Patients with at least one Treatment Emergent Adverse Event
    End point type
    Primary
    End point timeframe
    up to EOS
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The End Points such as Treatment-Emergent Serious Adverse Events, Treatment-Emergent Adverse Events, Treatment-Emergent Adverse Events due to infection, Hypersensitivity and infusion-related reactions were described using descriptive statistics.
    End point values
    		 Maintenance Switch
    Number of subjects analysed
    159 [8]
    143 [9]
    Units: percentage
        number (not applicable)
    53.5
    53.8
    Notes
    [8] - Safety population
    [9] - Safety population
    No statistical analyses for this end point

    Primary: Treatment-Emergent Adverse Events due to infection

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    End point title
    		 Treatment-Emergent Adverse Events due to infection [10]
    End point description
    Number of Patients with at least one Treatment Emergent Adverse Event due to infection
    End point type
    Primary
    End point timeframe
    up to EOS
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The End Points such as Treatment-Emergent Serious Adverse Events, Treatment-Emergent Adverse Events, Treatment-Emergent Adverse Events due to infection, Hypersensitivity and infusion-related reactions were described using descriptive statistics.
    End point values
    		 Maintenance Switch
    Number of subjects analysed
    159 [11]
    143 [12]
    Units: percentage
        number (not applicable)
    31.4
    32.9
    Notes
    [11] - Safety population
    [12] - Safety population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to EOS
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Maintenance
    Reporting group description
    		 -

    Reporting group title
    Switch
    Reporting group description
    		 -

    Serious adverse events
    		 Maintenance Switch
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 159 (7.55%)
    13 / 143 (9.09%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer stage II
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal T-cell lymphoma
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myeloproliferative disorder
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer stage I
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer stage III
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia megaloblastic
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Medical device complication
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Oesophageal perforation
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine polyp
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Interstitial lung disease
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pseudarthrosis
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial cyst
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist deformity
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected dermal cyst
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salpingitis
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Maintenance Switch
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 159 (19.50%)
    28 / 143 (19.58%)
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    5 / 159 (3.14%)
    9 / 143 (6.29%)
         occurrences all number
    5
    9
    Latent tuberculosis
         subjects affected / exposed
    10 / 159 (6.29%)
    5 / 143 (3.50%)
         occurrences all number
    10
    5
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 159 (5.03%)
    6 / 143 (4.20%)
         occurrences all number
    9
    6
    Urinary tract infection
         subjects affected / exposed
    8 / 159 (5.03%)
    8 / 143 (5.59%)
         occurrences all number
    9
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 May 2012
    Summary of significant changes includes the following: • Amended the number of study centers/countries • Clarified visit window and visit intervals • Amended Exclusion Criteria 9 • Amended safety endpoints analysis • Clarified ACR core set of variables • Amended the immunogenicity analysis • Clarified monitoring and reporting of AEs • Clarified analysis of serum pregnancy test • Clarified analysis of sample for clinical laboratory assessments • Clarified back-up sample of immunogenicity analysis • Clarified concomitant medications • Amended demography and MH • Clarified SAE data entry • Clarified coding of AEs, MH, previous and concomitant treatments • Added rescue therapy • Added reporting of changes in terms of dose of concomitant medication • Other clarifications and administrative changes

    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.
    None reported
    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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