Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Multicenter, Double-Blind, Randomized, 2-Arm, Parallel-Group, Equivalence Study Evaluating Efficacy and Safety Similarity of Mylan Adalimumab (MYL-1401A) Compared With Humira® in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis

    Summary
    EudraCT number
    		 2014-003420-46
    Trial protocol
    		 HU   DE   EE   BG  
    Global end of trial date
    06 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Mar 2018
    First version publication date
    08 Mar 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MYL-1401A-3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02714322
    WHO universal trial number (UTN)
    		 U1111-1164-6368
    Sponsors
    Sponsor organisation name
    Mylan GmbH
    Sponsor organisation address
    Thurgauerstrasse 40 , Zürich , Switzerland, 8050
    Public contact
    Clinical Development Lead, Mylan GmbH , +91 80 66728952 , PrasannaC.Ganapathi@mylan.in
    Scientific contact
    Clinical Development Lead, Mylan GmbH , +91 80 66728952 , PrasannaC.Ganapathi@mylan.in
    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
    05 Apr 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the equivalence of MYL-1401A to Humira® with regards to efficacy at Week 12 in subjects with moderate-to-severe chronic plaque psoriasis.
    Protection of trial subjects
    The study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki, ICH E6(R1) guidelines and all applicable regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 May 2015
    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
    Poland: 143
    Country: Number of subjects enrolled
    Bulgaria: 16
    Country: Number of subjects enrolled
    Estonia: 88
    Country: Number of subjects enrolled
    Hungary: 20
    Country: Number of subjects enrolled
    Russian Federation: 10
    Country: Number of subjects enrolled
    Ukraine: 17
    Worldwide total number of subjects
    294
    EEA total number of subjects
    267
    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)
    278
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 - Age: 18 to 75 years, inclusive - Gender: male or female - Body surface area (BSA) ≥10%, PASI ≥12, and sPGA ≥3 (moderate)

    Pre-assignment
    Screening details
    		 Three hundred sixty-three (363) patients were screened for the study, and 294 patients were randomized to study treatment.

    Period 1
    Period 1 title
    Active Treatment Phase (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
    		 Humira®
    Arm description
    		 Humira®
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Humira
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Initial dose of 80 mg, followed by 40 mg given every other week starting 1 week after initial dose

    Arm title
    		 MYL-1401A
    Arm description
    		 Mylan's Adalimumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    MYL-1401A
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Initial dose of 80 mg, followed by 40 mg given every other week starting 1 week after initial dose

    Number of subjects in period 1
    		Humira® MYL-1401A
    Started
    98
    196
    Week 12
    96
    194
    Completed
    86
    172
    Not completed
    12
    24
         Consent withdrawn by subject
    4
    10
         Physician decision
    -
    3
         Adverse event, non-fatal
    1
    3
         Other
    1
    2
         Lost to follow-up
    -
    2
         Missing
    1
    -
         Lack of efficacy
    5
    4

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Humira®
    Reporting group description
    		 Humira®

    Reporting group title
    MYL-1401A
    Reporting group description
    		 Mylan's Adalimumab

    Reporting group values
    		 Humira® MYL-1401A Total
    Number of subjects
    		 98 196 294
    Age categorical
    Units: Subjects
        < 45 years
    		 62 98 160
        >= 45 years
    		 36 98 134
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.2 ± 12.53 44.7 ± 12.52 -
    Gender categorical
    Units: Subjects
        Female
    		 24 65 89
        Male
    		 74 131 205
    Race
    Units: Subjects
        White
    		 98 196 294
    Presence of Psoriatic Arthritis
    Units: Subjects
        Yes
    		 35 73 108
        No
    		 63 123 186
    Baseline PASI Score
    Units: Subjects
        12 to 20
    		 28 67 95
        > 20
    		 70 129 199
    Baseline SPGA Score
    Units: Subjects
        3 (moderate)
    		 60 122 182
        4 or 5 ( severe to very severe)
    		 38 74 112
    Baseline BSA Involvement
    Units: Subjects
        10% to 30%
    		 43 85 128
        > 30%
    		 52 106 158
        Missing
    		 3 5 8

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Humira®
    Reporting group description
    		 Humira®

    Reporting group title
    MYL-1401A
    Reporting group description
    		 Mylan's Adalimumab

    Subject analysis set title
    ITT Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients who were randomly assigned to study treatment. Patients in the ITT set were categorized to the treatment randomly assigned.

    Primary: Psoriasis Area and Severity Index Percent Improvement From Baseline to Week 12

    		 Close Top of page
    End point title
    		 Psoriasis Area and Severity Index Percent Improvement From Baseline to Week 12
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 Humira® MYL-1401A
    Number of subjects analysed
    97
    196
    Units: percent
        arithmetic mean (standard deviation)
    86.563 ± 13.8650
    85.498 ± 16.1182
    Statistical analysis title
    		 Analysis of covariance
    Comparison groups
    Humira® v MYL-1401A
    Number of subjects included in analysis
    293
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 LS mean difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 2.9

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    60 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Humira
    Reporting group description
    		 Humira

    Reporting group title
    MYL-1401A
    Reporting group description
    		 Mylan's Adalimumab

    Serious adverse events
    		 Humira MYL-1401A
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 97 (5.15%)
    4 / 196 (2.04%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Postoperative respiratory failure
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 196 (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
    Headache
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 196 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Sarcoidosis
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric ulcer perforation
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal polyp
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 196 (0.51%)
         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
    Ovarian cyst
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 196 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 196 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 196 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Chronic tonsillitis
         subjects affected / exposed
    1 / 97 (1.03%)
    0 / 196 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 97 (0.00%)
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Humira MYL-1401A
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 97 (19.59%)
    33 / 196 (16.84%)
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    7 / 97 (7.22%)
    8 / 196 (4.08%)
         occurrences all number
    7
    9
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 97 (3.09%)
    15 / 196 (7.65%)
         occurrences all number
    3
    20
    Pharyngitis
         subjects affected / exposed
    6 / 97 (6.19%)
    9 / 196 (4.59%)
         occurrences all number
    6
    9
    Tonsillitis
         subjects affected / exposed
    5 / 97 (5.15%)
    2 / 196 (1.02%)
         occurrences all number
    5
    2

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Mar 2016
    Amendment was based on regulatory interactions and scientific advice from the European Medicines Agency and resulted in changes to the primary objective.
    06 May 2016
    Amendment was based on scientific advice from the United States Food and Drug Administration received on March 8, 2016. An assessment of safety and immunogenicity following a single transition from the reference product to the proposed biosimilar product was requested in the planned 351(k) Biologics License Application submission to support the safe use of MYL-140A in nontreatment naïve patients.

    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.

    European Medicines Agency © 1995-Sat May 04 12:54:51 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA