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    Clinical Trial Results:
    An Open Label Non-Randomized Study to Characterize the Steady State Pharmacokinetics of Sulfasalazine Delayed Release Tablets in Children With Juvenile Idiopathic Arthritis

    Summary
    EudraCT number
    		 2017-000307-24
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    21 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Jun 2022
    First version publication date
    10 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A0031005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00637780
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    28 Jun 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To characterise the steady state pharmacokinetics of sulfasalazine delayed release tablets in juvenile idiopathic arthritis subjects.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Jun 2010
    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
    Mexico: 1
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    2
    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)
    0
    Adolescents (12-17 years)
    2
    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
    		 The last subject enrolled in 2014 but the study was kept open for another 2 years and enrollment was not stopped. However, by 2016, no additional subjects were enrolled and thus the study was closed.

    Pre-assignment
    Screening details
    		 A total of 2 subjects were screened and enrolled in this study at the time of study termination. Both subjects completed 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
    		 Sulfasalazine in Juvenile Idiopathic Arthritis
    Arm description
    		 All subjects received sulfasalazine 30-50 milligrams (mg) per kilograms (kg) per day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-milligram (mg) tablets.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sulfasalazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received sulfasalazine at a dose of 30-50 mg per kg per day twice daily orally.

    Number of subjects in period 1
    		Sulfasalazine in Juvenile Idiopathic Arthritis
    Started
    2
    Completed
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sulfasalazine in Juvenile Idiopathic Arthritis
    Reporting group description
    		 All subjects received sulfasalazine 30-50 milligrams (mg) per kilograms (kg) per day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-milligram (mg) tablets.

    Reporting group values
    		 Sulfasalazine in Juvenile Idiopathic Arthritis Total
    Number of subjects
    		 2 2
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 2 2
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 15.0 ± 1.4 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 1 1
        Male
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Sulfasalazine in Juvenile Idiopathic Arthritis
    Reporting group description
    		 All subjects received sulfasalazine 30-50 milligrams (mg) per kilograms (kg) per day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-milligram (mg) tablets.

    Primary: Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin)

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    End point title
    		 Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin) [1]
    End point description
    The 2 subjects who were enrolled and completed the study at the time of study termination were included in all analyses.
    End point type
    Primary
    End point timeframe
    Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
    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: Only descriptive analysis was planned for this end point.
    End point values
    		 Sulfasalazine in Juvenile Idiopathic Arthritis
    Number of subjects analysed
    2
    Units: Micrograms per milliliter
    number (not applicable)
        Cmax - Value 1
    17.6
        Cmax - Value 2
    4.51
        Cmin - Value 1
    4.28
        Cmin - Value 2
    0.988
    No statistical analyses for this end point

    Primary: Sulfasalazine Time for Cmax (Tmax) at Steady State

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    End point title
    		 Sulfasalazine Time for Cmax (Tmax) at Steady State [2]
    End point description
    The 2 subjects who were enrolled and completed the study at the time of study termination were included in all analyses.
    End point type
    Primary
    End point timeframe
    Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
    Notes
    [2] - 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: Only descriptive analysis was planned for this end point.
    End point values
    		 Sulfasalazine in Juvenile Idiopathic Arthritis
    Number of subjects analysed
    2
    Units: hours
    number (not applicable)
        Value 1
    2.02
        Value 2
    5.92
    No statistical analyses for this end point

    Primary: Sulfasalazine Area Under the Concentration-time Profile From Time Zero to Time Tau, the Dosing Interval (AUCtau) at Steady State

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    End point title
    		 Sulfasalazine Area Under the Concentration-time Profile From Time Zero to Time Tau, the Dosing Interval (AUCtau) at Steady State [3]
    End point description
    The 2 subjects who were enrolled and completed the study at the time of study termination were included in all analyses.
    End point type
    Primary
    End point timeframe
    Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
    Notes
    [3] - 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: Only descriptive analysis was planned for this end point.
    End point values
    		 Sulfasalazine in Juvenile Idiopathic Arthritis
    Number of subjects analysed
    2
    Units: Micrograms*hour per millilitre
    number (not applicable)
        Value 1
    110
        Value 2
    34.7
    No statistical analyses for this end point

    Primary: Sulfapyridine Steady State Cmax and Cmin

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    End point title
    		 Sulfapyridine Steady State Cmax and Cmin [4]
    End point description
    Sulfapyridine and 5-aminosalicylic acid (5-ASA) are primary metabolites of sulfasalazine, the study drug. The 2 subjects who were enrolled and completed the study at the time of study termination were included in all analyses.
    End point type
    Primary
    End point timeframe
    Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
    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: Only descriptive analysis was planned for this end point.
    End point values
    		 Sulfasalazine in Juvenile Idiopathic Arthritis
    Number of subjects analysed
    2
    Units: Micrograms per milliliter
    number (not applicable)
        Cmax - Value 1
    21.7
        Cmax - Value 2
    7.68
        Cmin - Value 1
    14.7
        Cmin - Value 2
    4.79
    No statistical analyses for this end point

    Primary: Sulfapyridine Tmax at Steady State

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    End point title
    		 Sulfapyridine Tmax at Steady State [5]
    End point description
    Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug. The 2 subjects who were enrolled and completed the study at the time of study termination were included in all analyses.
    End point type
    Primary
    End point timeframe
    Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
    Notes
    [5] - 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: Only descriptive analysis was planned for this end point.
    End point values
    		 Sulfasalazine in Juvenile Idiopathic Arthritis
    Number of subjects analysed
    2
    Units: hours
    number (not applicable)
        Value 1
    4.00
        Value 2
    11.9
    No statistical analyses for this end point

    Primary: Sulfapyridine AUCtau at Steady State

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    End point title
    		 Sulfapyridine AUCtau at Steady State [6]
    End point description
    Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug. The 2 subjects who were enrolled and completed the study at the time of study termination were included in all analyses.
    End point type
    Primary
    End point timeframe
    Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
    Notes
    [6] - 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: Only descriptive analysis was planned for this end point.
    End point values
    		 Sulfasalazine in Juvenile Idiopathic Arthritis
    Number of subjects analysed
    2
    Units: Micrograms*hour per millilitre
    number (not applicable)
        Value 1
    232
        Value 2
    67.3
    No statistical analyses for this end point

    Primary: 5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin

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    End point title
    		 5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin [7]
    End point description
    Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug. The 2 subjects who were enrolled and completed the study at the time of study termination were included in all analyses.
    End point type
    Primary
    End point timeframe
    Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
    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: Only descriptive analysis was planned for this end point.
    End point values
    		 Sulfasalazine in Juvenile Idiopathic Arthritis
    Number of subjects analysed
    2
    Units: Micrograms per milliliter
    number (not applicable)
        Cmax - Value 1
    0.208
        Cmax - Value 2
    0.0982
        Cmin - Value 1
    0.0439
        Cmin - Value 2
    0.0816
    No statistical analyses for this end point

    Primary: 5-aminosalicylic Acid (5-ASA) Tmax at Steady State

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    End point title
    		 5-aminosalicylic Acid (5-ASA) Tmax at Steady State [8]
    End point description
    Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug. The 2 subjects who were enrolled and completed the study at the time of study termination were included in all analyses.
    End point type
    Primary
    End point timeframe
    Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
    Notes
    [8] - 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: Only descriptive analysis was planned for this end point.
    End point values
    		 Sulfasalazine in Juvenile Idiopathic Arthritis
    Number of subjects analysed
    2
    Units: hours
    number (not applicable)
        Value 1
    0.000
        Value 2
    11.9
    No statistical analyses for this end point

    Primary: 5-aminosalicylic Acid (5-ASA) AUCtau at Steady State

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    End point title
    		 5-aminosalicylic Acid (5-ASA) AUCtau at Steady State [9]
    End point description
    Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug. The 2 subjects who were enrolled and completed the study at the time of study termination were included in all analyses.
    End point type
    Primary
    End point timeframe
    Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
    Notes
    [9] - 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: Only descriptive analysis was planned for this end point.
    End point values
    		 Sulfasalazine in Juvenile Idiopathic Arthritis
    Number of subjects analysed
    2
    Units: Micrograms*hour per milliliter
    number (not applicable)
        Value 1
    1.63
        Value 2
    1.04
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs

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    End point title
    		 Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs
    End point description
    An adverse event (AE) was any untoward medical occurrence attributed to study drug in a subject who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; initial or prolonged inpatient hospitalisation; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The 2 subjects who were enrolled and completed the study at the time of study termination were included in all analyses.
    End point type
    Secondary
    End point timeframe
    28 Days post last dose (maximum up to Day 35)
    End point values
    		 Sulfasalazine in Juvenile Idiopathic Arthritis
    Number of subjects analysed
    2
    Units: Subjects
        TEAEs
    0
        SAEs
    0
        Withdrawals due to TEAEs
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Laboratory Test Abnormalities

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    End point title
    		 Number of Subjects With Laboratory Test Abnormalities
    End point description
    Number of subjects with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes,clinical chemistry, and urinalysis (dipstick and microscopy). The 2 subjects who were enrolled and completed the study at the time of study termination were included in all analyses.
    End point type
    Secondary
    End point timeframe
    Up to Day 7
    End point values
    		 Sulfasalazine in Juvenile Idiopathic Arthritis
    Number of subjects analysed
    2
    Units: Subjects
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Vital Signs Values Meeting Categorical Summarization Criteria

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    End point title
    		 Number of Subjects With Vital Signs Values Meeting Categorical Summarization Criteria
    End point description
    Vital sign values which met categorical summarisation criteria included: supine/sitting pulse rate less than (<) 40 or more than (>) 120 beats per minute (bpm); erect pulse rate <40 or >140 bpm; changes from baseline in same posture of systolic blood pressure (SBP) more than or equal to (>=) 30 millimeters of mercury (mm Hg) or diastolic blood pressure (DBP) >=20 mm Hg; SBP <90 mm Hg; and DBP <50 mm Hg. The 2 subjects who were enrolled and completed the study at the time of study termination were included in all analyses.
    End point type
    Secondary
    End point timeframe
    Up to Day 7
    End point values
    		 Sulfasalazine in Juvenile Idiopathic Arthritis
    Number of subjects analysed
    2
    Units: Subjects
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    28 Days post last dose (maximum up to Day 35)
    Adverse event reporting additional description
    All treated subjects were analysed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another participant, or one subject may have experienced both a serious and non-serious event during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NA
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Sulfasalazine in Juvenile Idiopathic Arthritis
    Reporting group description
    		 All subjects received sulfasalazine 30-50 mg per kg per day, divided into BID doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.

    Serious adverse events
    		 Sulfasalazine in Juvenile Idiopathic Arthritis
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Sulfasalazine in Juvenile Idiopathic Arthritis
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no non-serious adverse events were reported in this study.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 May 2012
    Subject selection, revised inclusion criteria #5 to indicate subjects must weigh at least 20 kg.

    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.
    The study was terminated prematurely and only 2 subjects were enrolled and completed the study.
    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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