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    Clinical Trial Results:
    A Multicenter, Open-label Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis

    Summary
    EudraCT number
    2014-004558-33
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    05 Sep 2011

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Apr 2016
    First version publication date
    13 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M10-240
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00690573
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AbbVie
    Sponsor organisation address
    1 North Waukegan Road, North Chicago, IL, United States, 60064
    Public contact
    Global Medical Information, AbbVie, 001 800-633-9110,
    Scientific contact
    Shigeki Hashimoto, AbbVie, shigeki.hashimoto@abbvie.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Sep 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Sep 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese children with Polyarticular Juvenile Rheumatoid Arthritis
    Protection of trial subjects
    Subject and/or legal guardian read and understood information provided about the study and gave written permission. If a subject had an ability to provide an assent to participating in the clinical trial, the subject provided written informed assent. If a subject could not provide his/her signature, the investigator or clinical trial support staff confirmed the subject's willingness and recorded it.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 May 2008
    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
    Japan: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    0
    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)
    8
    Adolescents (12-17 years)
    17
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Adalimumab dose was determined by baseline body weight (20 mg for subjects weighing < 30 kg, 40 mg for subjects weighing 30 kg or more) through Week 14. After Week 16, dose was based on body weight measured at Week 16 and every 12 weeks. Twenty subjects received concomitant methotrexate therapy during the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Adalimumab
    Arm description
    Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
    Arm type
    Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira, ABT-D2E7
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).

    Number of subjects in period 1
    Adalimumab
    Started
    25
    Completed
    16
    Not completed
    9
         Lack of efficacy
    8
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).

    Reporting group values
    Adalimumab Total
    Number of subjects
    25 25
    Age Categorical
    Units: participants
        <=18 years
    25 25
        Between 18 and 65 years
    0 0
        >=65 years
    0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    13 ± 3.38 -
    Gender, Male/Female
    Units: participants
        Female
    20 20
        Male
    5 5

    End points

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    End points reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).

    Primary: Number of subjects achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16

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    End point title
    Number of subjects achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16 [1]
    End point description
    Response defined as at least 30% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 30% worsening in not more than 1 JRA criterion, compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. The analysis was conducted using the full analysis set (FAS) population, which was defined as all subjects who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Week 16
    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: Descriptive data are summarized for this end point per protocol.
    End point values
    Adalimumab
    Number of subjects analysed
    25
    Units: Participants
        number (not applicable)
    23
    No statistical analyses for this end point

    Secondary: Number of subjects achieving PedACR50 and PedACR70 Responses at Week 16

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    End point title
    Number of subjects achieving PedACR50 and PedACR70 Responses at Week 16
    End point description
    Response defined as at least 50/70% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 50/70% worsening in not more than 1 JRA criterion compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. The analysis was conducted using the FAS population. Missing values were treated as non-responders.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Adalimumab
    Number of subjects analysed
    25
    Units: Participants
    number (not applicable)
        Number of Subjects Achieving PedACR50 at Week 16
    22
        Number of Subjects Achieving PedACR70 at Week 16
    15
    No statistical analyses for this end point

    Secondary: Number of Subjects Achieving PedACR 30/50/70 Responses

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    End point title
    Number of Subjects Achieving PedACR 30/50/70 Responses
    End point description
    The analysis was conducted using the full analysis set FAS population as observed. N=25 at Weeks 2, 4, and the Final Visit; N=24 at Weeks 8, 24, and 36; N=23 at Week 48; N=22 at Week 60; N=19 at Weeks 72 and 96; N=11 at Week 120; and N=5 at Week 144.
    End point type
    Secondary
    End point timeframe
    Week 2, 4, 8, and 24, every 12 weeks from Week 24 to Week 60, and every 24 weeks from Week 72 to the final visit
    End point values
    Adalimumab
    Number of subjects analysed
    25
    Units: Participants
    number (not applicable)
        Number of subjects achieving PedACR30 at Week 2
    15
        Number of subjects achieving PedACR30 at Week 4
    16
        Number of subjects achieving PedACR30 at Week 8
    19
        Number of subjects achieving PedACR30 at Week 24
    21
        Number of subjects achieving PedACR30 at Week 36
    22
        Number of subjects achieving PedACR30 at Week 48
    21
        Number of subjects achieving PedACR30 at Week 60
    20
        Number of subjects achieving PedACR30 at Week 72
    19
        Number of subjects achieving PedACR30 at Week 96
    18
        Number of subjects achieving PedACR30 at Week 120
    11
        Number of subjects achieving PedACR30 at Week 144
    5
        Number of subjects achieving PedACR30- Final Visit
    22
        Number of subjects achieving PedACR50 at Week 2
    7
        Number of subjects achieving PedACR50 at Week 4
    13
        Number of subjects achieving PedACR50 at Week 8
    15
        Number of subjects achieving PedACR50 at Week 24
    19
        Number of subjects achieving PedACR50 at Week 36
    22
        Number of subjects achieving PedACR50 at Week 48
    19
        Number of subjects achieving PedACR50 at Week 60
    20
        Number of subjects achieving PedACR50 at Week 72
    18
        Number of subjects achieving PedACR50 at Week 96
    18
        Number of subjects achieving PedACR50 at Week 120
    11
        Number of subjects achieving PedACR50 at Week 144
    5
        Number of subjects achieving PedACR50- Final Visit
    20
        Number of subjects achieving PedACR70 at Week 2
    1
        Number of subjects achieving PedACR70 at Week 4
    7
        Number of subjects achieving PedACR70 at Week 8
    8
        Number of subjects achieving PedACR70 at Week 24
    15
        Number of subjects achieving PedACR70 at Week 36
    19
        Number of subjects achieving PedACR70 at Week 48
    17
        Number of subjects achieving PedACR70 at Week 60
    16
        Number of subjects achieving PedACR70 at Week 72
    15
        Number of subjects achieving PedACR70 at Week 96
    14
        Number of subjects achieving PedACR70 at Week 120
    11
        Number of subjects achieving PedACR70 at Week 144
    5
        Number of subjects achieving PedACR70- Final Visit
    17
    No statistical analyses for this end point

    Secondary: Mean serum adalimumab concentration

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    End point title
    Mean serum adalimumab concentration
    End point description
    Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method based on a double-antigen technique. Concentrations are reported as micrograms per milliliter (mcg/mL). For the 20 mg dose, N = 8 at each timepoint. For the 40 mg dose, N = 17 at Weeks 2 and 4; N = 16 at Weeks 8, 16, and 24; N = 14 at Week 36; N = 15 at Week 48; and N = 14 at Week 60.
    End point type
    Secondary
    End point timeframe
    Week 2, 4, 8, 16, and 24, and every 12 weeks up to Week 60
    End point values
    Adalimumab
    Number of subjects analysed
    25
    Units: mcg/mL
    arithmetic mean (standard deviation)
        20 mg dose at Week 2
    5.24 ± 1.74
        20 mg dose at Week 4
    5.46 ± 5.18
        20 mg dose at Week 8
    6.15 ± 5.88
        20 mg dose at Week 16
    5.73 ± 5.26
        20 mg dose at Week 24
    5.79 ± 6.51
        20 mg dose at Week 36
    7.6 ± 7.58
        20 mg dose at Week 48
    7.97 ± 6.69
        20 mg dose at Week 60
    11.4 ± 9.87
        40 mg dose at Week 2
    5.03 ± 1.45
        40 mg dose at Week 4
    5.63 ± 2.71
        40 mg dose at Week 8
    8.66 ± 4.41
        40 mg dose at Week 16
    10.8 ± 6.15
        40 mg dose at Week 24
    11.9 ± 6.8
        40 mg dose at Week 36
    12.6 ± 6.44
        40 mg dose at Week 48
    13 ± 8.89
        40 mg dose at Week 60
    13.1 ± 6.73
    No statistical analyses for this end point

    Secondary: Number of subjects positive for anti-adalimumab antibodies (AAA)

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    End point title
    Number of subjects positive for anti-adalimumab antibodies (AAA)
    End point description
    Serum samples with adalimumab concentration below 2 mcg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 20 ng/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose.
    End point type
    Secondary
    End point timeframe
    Week 24 and Week 60
    End point values
    Adalimumab
    Number of subjects analysed
    25
    Units: Participants
    number (not applicable)
        Number of subjects with AAA by Week 24
    4
        Number of subjects with AAA by Week 60
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).

    Serious adverse events
    Adalimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 25 (24.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Pharyngolaryngeal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Juvenile arthritis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Hepatitis B
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Adalimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 25 (100.00%)
    Immune system disorders
    Seasonal allergy
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    General disorders and administration site conditions
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    3
    Injection site reaction
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 25 (16.00%)
         occurrences all number
    4
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 25 (20.00%)
         occurrences all number
    6
    Injury, poisoning and procedural complications
    Contusion
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Hand fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Joint sprain
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 25 (16.00%)
         occurrences all number
    5
    Investigations
    Antinuclear antibody positive
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    3
    DNA antibody positive
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Iron deficiency anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 25 (20.00%)
         occurrences all number
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Rhinitis allergic
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Pharyngolaryngeal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 25 (16.00%)
         occurrences all number
    5
    Rhinorrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    3
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    16
    Eye disorders
    Conjunctivitis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    4
    Conjunctivitis allergic
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Keratoconjunctivitis sicca
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal pain upper
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Abdominal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Dental caries
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Constipation
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    4
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Stomatitis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Hepatobiliary disorders
    Hepatic function abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Acne
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Dermatitis atopic
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Dermatitis bullous
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    3
    Urticaria
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 25 (24.00%)
         occurrences all number
    7
    Eczema
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 25 (20.00%)
         occurrences all number
    7
    Rash
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 25 (16.00%)
         occurrences all number
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Juvenile arthritis
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    3
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Infections and infestations
    Hordeolum
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 25 (20.00%)
         occurrences all number
    5
    Impetigo
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    4
    Gastroenteritis
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 25 (24.00%)
         occurrences all number
    10
    Nasopharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 25 (56.00%)
         occurrences all number
    33
    Influenza
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 25 (32.00%)
         occurrences all number
    8
    Oral herpes
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    4
    Upper respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 25 (56.00%)
         occurrences all number
    38
    Pharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 25 (32.00%)
         occurrences all number
    12

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jun 2008
    - Updated the approval status of adalimumab. - Added the procedure to confirm subject's safety after the dose escalation. - Added the detailed explanation about when MTX dose was changed before the enrollment to the procedure for eligibility confirmation. - Changed the timing to conduct chest X-ray. - Changed the contact information of the sponsor.
    02 Feb 2009
    - Changed the amount of MTX described in inclusion criteria #2 from 10 mg/m^2/week to 8 to 10 mg/m^2/week to relax this inclusion criterion. - Updated the approval status of adalimumab. - Extended the enrollment period.
    22 Jun 2009
    - Added the criteria for interruption due to clinical remission. - Changed the procedure of the protocol deviation. - Changed the medical expert and adalimumab concentration assay institution.
    10 Sep 2010
    - Deleted the section for Dose escalation
    27 May 2011
    - Added the follow-up test at approval.

    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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