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    The EU Clinical Trials Register currently displays   41228   clinical trials with a EudraCT protocol, of which   6756   are clinical trials conducted with subjects less than 18 years old.
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    Clinical Trial Results:
    A Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis

    Summary
    EudraCT number
    2015-002924-17
    Trial protocol
    NL   BE  
    Global end of trial date
    13 Jun 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    18 May 2019
    First version publication date
    18 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLR_15_05
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02534896
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Sun Pharma Global FZE
    Sponsor organisation address
    Office number 43 Bloc-Y, SAIF Zone, Sharjah, United Arab Emirates, 122304
    Public contact
    Head-Clinical Development, Sun Pharma Advanced Research Company Limited, clinical.trials@sparcmail.com
    Scientific contact
    Head-Clinical Development, Sun Pharma Advanced Research Company Limited, clinical.trials@sparcmail.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
    30 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess efficacy and safety (treatment of signs and symptoms) of Nanocort in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation in comparison to a standard of care medication (Depo-Medrol).
    Protection of trial subjects
    This study was conducted in compliance with the protocol and in accordance with International Council for Harmonisation (ICH) guidance, Good Clinical Practice (GCP) standards, the Declaration of Helsinki, the European Clinical Trial Directive 2001/20/EC of 4 Apr 2001 and European ClinicalTrial Directive 2005/28/EC of 8 Apr 2005 and local ethical and legal requirements. Concomitant therapies taken for the long-term treatment of pre-existing conditions (as per Investigator’s opinion) could be continued during the study. However, these needed to be stabilized prior to entry and continued wherever practical without variation of dose or regimen during the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 Mar 2016
    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
    Netherlands: 120
    Country: Number of subjects enrolled
    Belgium: 30
    Worldwide total number of subjects
    150
    EEA total number of subjects
    150
    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)
    150
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 150 subjects were randomized in the study in 3 treatment groups.

    Period 1
    Period 1 title
    Period 1 (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Arm 1
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Treatment I
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intramuscular use, Intravenous use
    Dosage and administration details
    Day 1 and 15

    Arm title
    Arm 2
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Treatment II
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intramuscular use, Intravenous use
    Dosage and administration details
    Day 1 and 15 up to 12 weeks

    Arm title
    Arm 3
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Treatment III
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intramuscular use, Intravenous use
    Dosage and administration details
    Day 1 and 15

    Number of subjects in period 1
    Arm 1 Arm 2 Arm 3
    Started
    49
    52
    49
    Completed
    45
    51
    48
    Not completed
    4
    1
    1
         Adverse event, non-fatal
    2
    1
    1
         insufficient therapeutic resonse
    2
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    -

    Reporting group title
    Arm 2
    Reporting group description
    -

    Reporting group title
    Arm 3
    Reporting group description
    -

    Reporting group values
    Arm 1 Arm 2 Arm 3 Total
    Number of subjects
    49 52 49 150
    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)
    55.3 ± 13.79 56.4 ± 10.74 56.7 ± 11.18 -
    Gender categorical
    Units: Subjects
        Female
    38 42 35 115
        Male
    11 10 14 35

    End points

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    End points reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    -

    Reporting group title
    Arm 2
    Reporting group description
    -

    Reporting group title
    Arm 3
    Reporting group description
    -

    Primary: Good/Moderate European League Against Rheumatism Responders

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    End point title
    Good/Moderate European League Against Rheumatism Responders
    End point description
    End point type
    Primary
    End point timeframe
    Day 8
    End point values
    Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    49
    52
    49
    Units: number of subjects
        number (not applicable)
    42
    45
    32
    Statistical analysis title
    Arm 1 efficacy endpoint statistical analysis
    Comparison groups
    Arm 1 v Arm 3
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.018
    Method
    Hochberg and Gatekeeping
    Confidence interval
    Statistical analysis title
    Arm 2 efficacy endpoint statistical ana...
    Comparison groups
    Arm 3 v Arm 2
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.007
    Method
    Hochberg and Gatekeeping
    Confidence interval

    Secondary: Good European League Against Rheumatism -Responders

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    End point title
    Good European League Against Rheumatism -Responders
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8
    End point values
    Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    49
    52
    49
    Units: Number of responders
        number (not applicable)
    21
    26
    10
    Statistical analysis title
    Arm 1 efficacy endpoint statistical analysis
    Comparison groups
    Arm 1 v Arm 3
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.028
    Method
    Hochberg and Gatekeeping
    Confidence interval
    Statistical analysis title
    Arm 2 efficacy endpoint statistical ana...
    Comparison groups
    Arm 2 v Arm 3
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.003
    Method
    Hochberg and Gatekeeping
    Confidence interval

    Secondary: Good/Moderate European League Against Rheumatism Responders

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    End point title
    Good/Moderate European League Against Rheumatism Responders
    End point description
    End point type
    Secondary
    End point timeframe
    Day 15
    End point values
    Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    49
    52
    49
    Units: Number of responders
        number (not applicable)
    42
    43
    42
    Statistical analysis title
    Arm 1 efficacy endpoint statistical analysis
    Comparison groups
    Arm 1 v Arm 3
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.96
    Method
    Hochberg and Gatekeeping
    Confidence interval
    Statistical analysis title
    Arm 2 efficacy endpoint statistical ana...
    Comparison groups
    Arm 2 v Arm 3
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.339
    Method
    Hochberg and Gatekeeping
    Confidence interval

    Secondary: Good European League Against Rheumatism Responders

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    End point title
    Good European League Against Rheumatism Responders
    End point description
    End point type
    Secondary
    End point timeframe
    Day 15
    End point values
    Arm 1 Arm 2 Arm 3
    Number of subjects analysed
    49
    52
    49
    Units: Number of responders
        number (not applicable)
    24
    33
    21
    Statistical analysis title
    Arm 1 efficacy endpoint statistical analysis
    Comparison groups
    Arm 1 v Arm 3
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.573
    Method
    Hochberg and Gatekeeping
    Confidence interval
    Statistical analysis title
    Arm 2 efficacy endpoint statistical ana...
    Comparison groups
    Arm 2 v Arm 3
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.374
    Method
    Hochberg and Gatekeeping
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Week 12
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Treatment I
    Reporting group description
    -

    Reporting group title
    Treatment II
    Reporting group description
    -

    Reporting group title
    Treatment III
    Reporting group description
    -

    Serious adverse events
    Treatment I Treatment II Treatment III
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 49 (8.16%)
    1 / 52 (1.92%)
    2 / 49 (4.08%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neuroendocrine carcinoma of the skin
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
    Additional description: In Treatment I group, the event of hypersensitivity was unlikely related to IM injection and probably related to IV infusion. In Treatment II group, the event of hypersensitivity was not related to IM injection and related to IV infusion.
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Treatment I Treatment II Treatment III
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 49 (85.71%)
    46 / 52 (88.46%)
    39 / 49 (79.59%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    4 / 49 (8.16%)
    6 / 52 (11.54%)
    6 / 49 (12.24%)
         occurrences all number
    4
    6
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
    Additional description: One of the 3 subjects in the Treatment group II had Production Cough.
         subjects affected / exposed
    4 / 49 (8.16%)
    2 / 52 (3.85%)
    4 / 49 (8.16%)
         occurrences all number
    4
    3
    4
    Nervous system disorders
    Dizziness
    Additional description: One of the subjects in Treatment group I had Dizziness Exertional.
         subjects affected / exposed
    4 / 49 (8.16%)
    2 / 52 (3.85%)
    2 / 49 (4.08%)
         occurrences all number
    5
    2
    2
    Headache
    Additional description: One of the subjects in Treatment group III had Tension Headache.
         subjects affected / exposed
    8 / 49 (16.33%)
    9 / 52 (17.31%)
    6 / 49 (12.24%)
         occurrences all number
    11
    9
    9
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 49 (12.24%)
    6 / 52 (11.54%)
    5 / 49 (10.20%)
         occurrences all number
    6
    7
    9
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    9 / 49 (18.37%)
    6 / 52 (11.54%)
    1 / 49 (2.04%)
         occurrences all number
    9
    7
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 49 (12.24%)
    5 / 52 (9.62%)
    4 / 49 (8.16%)
         occurrences all number
    6
    6
    5

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Mar 2016
    The Rheumatoid Arthritis diagnosis selection criterion was amended in Amendment 2. There were no other major changes in the amended protocols.

    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
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