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    Clinical Trial Results:
    Efficacy of golimumab in early axial spondyloarthritis (axSpA) in relation to gut inflammation, an early remission induction study (GO GUT).

    Summary
    EudraCT number
    		 2017-001728-23
    Trial protocol
    		 BE  
    Global end of trial date
    14 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jul 2024
    First version publication date
    20 Jul 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2017/004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03270501
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Rheumatology, Gent University Hospital
    Sponsor organisation address
    Corneel Heymanslaan 10, Gent, Belgium, 9000
    Public contact
    Health, Innovation & Research Institute, Gent University Hospital, +32 9332 05 00, hiruz.ctu@uzgent.be
    Scientific contact
    Health, Innovation & Research Institute, Gent University Hospital, +32 9332 05 00, hiruz.ctu@uzgent.be
    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
    31 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Dec 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To describe and confirm the relationship between subclinical gut inflammation and axSpA. - To evaluate whether there is a higher need of anti-tumor necrosis factor α (anti-TNFα) treatment in axSpA patients with (subclinical) gut inflammation compared to those without.
    Protection of trial subjects
    Tight-control, treat-to-target therapy according to the current international recommendations for the management of axial spondyloarthritis
    Background therapy
    		 -
    Evidence for comparator
    		 The study has a single arm, no comparators are used
    Actual start date of recruitment
    08 Nov 2017
    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
    Belgium: 64
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    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)
    64
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients diagnosed with axial spondyloarthritis, fulfilling the trial's inclusion criteria were recruited across 3 rheumatology centres in Belgium, i.e. Gent University Hospital, Imelda Hospital in Bonheiden and Jessa Hospital in Hasselt between November 2017 and December 2022.

    Pre-assignment
    Screening details
    		 Main inclusion criteria were: expert diagnosis of axial spondyloarthritis, fulfillinf the ASAS classification criteria; treatment-naive status; symptom duration of less than 1 year; high disease activity and signs of inflammation at inclusion (positive MRI of the sacroiliac joints, elevated CRP).

    Pre-assignment period milestones
    Number of subjects started
    		 64
    Number of subjects completed
    		 64

    Period 1
    Period 1 title
    Pre-treatment period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Single arm study, no blinding implemented.

    Arms
    Arm title
    		 NSAIDs With Possible Step-up to Golimumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    NSAIDs with possible step up to Golimumab (Simponi s.c. 50mg 1x/4 weeks)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Solution for injection in pre-filled pen
    Routes of administration
    Injection , Oral use
    Dosage and administration details
    NSAIDs: All patients fulfilling the inclusion criteria will be treated according to the current recommendations for the management of axial spondyloarthritis, i.e. with 2 courses of NSAIDs in maximum tolerated anti-inflammatory dose. Specific NSAIDs and form of admonistration is chosen individually by the patient and treating rheumatologist. If sufficient response is acheived, the patients will continue receiving NSAIDs and after sustained remission, the therapy will be stopped. If therapy with NSAIDs provides insufficient control of disease activity, switch to therapy with Golimumab will be made. Golimumab: Patients who did not have a good treatment response to 2 NSAIDs, will be treated with golimumab adminiostered subcutanously (Simponi pre-filled pens 50mg/4 weeks). After sustained remission, the therapy will be stopped.

    Number of subjects in period 1
    		NSAIDs With Possible Step-up to Golimumab
    Started
    64
    Completed
    58
    Not completed
    6
         Protocol deviation
    6
    Period 2
    Period 2 title
    Treatment period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Single arm study protocol - no blinding implemented.

    Arms
    Arm title
    		 NSAIDs With Possible Step-up to Golimumab
    Arm description
    		 NSAIDs: All patients fulfilling the inclusion criteria will be treated according to the current recommendations for the management of axial spondyloarthritis, i.e. with 2 courses of NSAIDs. If sufficient response is acheived, the patients will continue receiving NSAIDs and after sustained remission, the therapy will be stopped. If therapy with NSAIDs provides insufficient control of disease activity, switch to therapy with Golimumab will be made. Golimumab: Patients who did not have a good treatment response to 2 NSAIDs, will be treated with golimumab sc 50mg/4 weeks. After sustained remission, the therapy will be stopped. All patients will undergo a ileocoloscopy at baseline and, if positive, at time of remission.
    Arm type
    		 Experimental

    Investigational medicinal product name
    NSAIDs with possible step up to Golimumab (Simponi s.c. 50mg 1x/4 weeks)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen, Capsule
    Routes of administration
    Oral use, Injection
    Dosage and administration details
    NSAIDs: All patients fulfilling the inclusion criteria will be treated according to the current recommendations for the management of axial spondyloarthritis, i.e. with 2 courses of NSAIDs in maximum tolerated anti-inflammatory dose. Specific NSAIDs and form of admonistration is chosen individually by the patient and treating rheumatologist. If sufficient response is acheived, the patients will continue receiving NSAIDs and after sustained remission, the therapy will be stopped. If therapy with NSAIDs provides insufficient control of disease activity, switch to therapy with Golimumab will be made. Golimumab: Patients who did not have a good treatment response to 2 NSAIDs, will be treated with golimumab adminiostered subcutanously (Simponi pre-filled pens 50mg/4 weeks). After sustained remission, the therapy will be stopped.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: According to the study protocol, a short period of time was allowed between patient enrollment and the start of the treatment (baseline period). During that time some patients' complaints spontaneously improved. As a result, these patients were no longer eligible to participate in the study.
    Number of subjects in period 2 [2]
    		NSAIDs With Possible Step-up to Golimumab
    Started
    58
    Completed
    55
    Not completed
    3
         Adverse event, non-fatal
    1
         Lost to follow-up
    2
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The reported worldwide number enrolled in the trial is 64, which is the number of patients who successfully completed the screening visit and received study-specific interventions (eg. biological sample collection). However, in the time between patient enrollment and the start of the treatment (baseline period) some patients' complaints spontaneously improved. As a result, these patients were no longer eligible to participate in the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 58 58
    Age categorical
    Adult patients between 18 and 64 years of age
    Units: Subjects
        Adults (18-64 years)
    		 58 58
    Age continuous
    Mean age of patients included in the trial
    Units: years
        arithmetic mean (standard deviation)
    		 28.2 ( 6.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 24 24
        Male
    		 34 34
    Ethnicity (NIH/OMB)
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0
        Not Hispanic or Latino
    		 56 56
        Unknown or Not Reported
    		 2 2
    HLA-B27
    Positive for HLA-B27 (%)
    Units: Subjects
        Positive
    		 50 50
        Negative
    		 8 8
    Assessment of SpondyloArthritis international Society (ASAS) criteria: Inflammatory Back Pain
    IBP according to experts: four out of five of the following parameters present: (1) age at onset less than 40 years, (2) insidious onset, (3) improvement with exercise, (4) no improvement with rest, (5) pain at night (with improvement upon getting up). (Reference: Ann Rheum Dis 2009;68:777-83)
    Units: Subjects
        Yes
    		 51 51
        No
    		 7 7
    Assessment of SpondyloArthritis international Society (ASAS) criteria: Arthritis
    Documented past or present active synovitis diagnosed by a doctor.
    Units: Subjects
        Yes
    		 5 5
        No
    		 53 53
    Assessment of SpondyloArthritis international Society (ASAS) criteria: Heel enthesitis
    Measure Description: Heel enthesitis: past or present spontaneous pain or tenderness at examination at the site of the insertion of the Achilles tendon or plantar fascia at the calcaneus. (Reference: Ann Rheum Dis 2009;68:777-83)
    Units: Subjects
        Yes
    		 3 3
        No
    		 55 55
    Assessment of SpondyloArthritis international Society (ASAS) criteria: Psoriasis
    Documented past or present psoriatic skin or nail lesions diagnosed by a doctor.
    Units: Subjects
        Yes
    		 0 0
        No
    		 58 58
    Assessment of SpondyloArthritis international Society (ASAS) criteria: Uveitis
    Documented past or present anterior uveitis, diagnosed by an ophthalmologist. (Reference: Ann Rheum Dis 2009;68:777-83)
    Units: Subjects
        Yes
    		 0 0
        No
    		 58 58
    Assessment of SpondyloArthritis international Society (ASAS) criteria: Dactylitis
    Documented past or present dactylitis diagnosed by a doctor. (Reference: Ann Rheum Dis 2009;68:777-83)
    Units: Subjects
        Yes
    		 0 0
        No
    		 58 58
    Assessment of SpondyloArthritis international Society (ASAS) criteria: Inflammatory bowel disease
    Documented past or present inflammatory bowel disease diagnosed by a doctor. (Reference: Ann Rheum Dis 2009;68:777-83)
    Units: Subjects
        Yes
    		 1 1
        No
    		 57 57
    Assessment of SpondyloArthritis international Society criteria: Elevated C-reactive protein
    Measured within 3 months priort to study inclusoon or at baseline and temporally associated with patient's complaints emergence of CRP above upper normal limit in the presence of back pain, after exclusion of other causes for elevated CRP concentration. (Reference: Ann Rheum Dis 2009;68:777-83)
    Units: Subjects
        Yes
    		 24 24
        No
    		 34 34
    Assessment of SpondyloArthritis international Society criteria: Family history of spondyloarthritis
    Patient reported presence in first-degree or second-degree relatives of any of the following: (a) ankylosing spondylitis, (b) psoriasis, (c) uveitis, (d) reactive arthritis, (e) inflammatory bowel disease. (Reference: Ann Rheum Dis 2009;68:777-83)
    Units: Subjects
        Yes
    		 22 22
        No
    		 36 36
    Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP
    ASDAS is a composite index to assess disease activity in axSpA. ASDAS parameters: 1) Total back pain 2) Patient global 3) Peripheral pain/swelling 4) Duration of morning stiffness 5) CRP in mg/L: ASDAS calculation: 0.121 × total back pain + 0.110 × patient global + 0.073 × peripheral pain/swelling + 0.058 × duration of morning stiffness + 0.579 × Ln(max(CRP,2)+1). Parameters 1-4 are reported by patients on a visual analogue score ranging from 0 to 10. Data from five variables combine to yield a score (minimum 0.636 to no defined upper limit), higher scores indicate higher disease activity.
    Units: Point on a continuous scale
        arithmetic mean (standard deviation)
    		 3.0 ( 0.9 ) -
    Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
    BASDAI is a measure of disease activity which was calculated based on 6 separate questionnaire items that were answered by the patients using visual analogue scale scales with range 0-10. A weighted average was performed, where items 5 and 6 had a weight of 0.5 whereas items 1, 2, 3 and 4 had a weight of 1. Range is from 0 to 10, with 10 indicating more severe disease activity.
    Units: Units on a continuous scale
        arithmetic mean (standard deviation)
    		 4.5 ( 1.5 ) -
    Bath Ankylosing Spondylitis Functional index (BASFI)
    BASFI is a measure of physical function which was calculated based on 10 separate questionnaire items that were answered by the patients using visual analogue scales with range 0-10, an average across 10 items was calculated. The range is 0-10 with 10 indicating that the level of physical functioning is more severely affected.
    Units: Units on a continuous scale
        arithmetic mean (standard deviation)
    		 3.0 ( 2.2 ) -
    CRP
    Inflammatory marker
    Units: mg/ml
        arithmetic mean (standard deviation)
    		 7.6 ( 11 ) -
    Body mass index (BMI)
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 23.3 ( 4.7 ) -
    Time from diagnosis
    ime from the first diagnosis of axial spondyloarthritis to enrollment in the trial
    Units: days
        median (standard deviation)
    		 37 ( 18 ) -

    End points

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    End points reporting groups
    Reporting group title
    NSAIDs With Possible Step-up to Golimumab
    Reporting group description
    		 -
    Reporting group title
    NSAIDs With Possible Step-up to Golimumab
    Reporting group description
    		 NSAIDs: All patients fulfilling the inclusion criteria will be treated according to the current recommendations for the management of axial spondyloarthritis, i.e. with 2 courses of NSAIDs. If sufficient response is acheived, the patients will continue receiving NSAIDs and after sustained remission, the therapy will be stopped. If therapy with NSAIDs provides insufficient control of disease activity, switch to therapy with Golimumab will be made. Golimumab: Patients who did not have a good treatment response to 2 NSAIDs, will be treated with golimumab sc 50mg/4 weeks. After sustained remission, the therapy will be stopped. All patients will undergo a ileocoloscopy at baseline and, if positive, at time of remission.

    Primary: Sustained clinical remission

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    End point title
    		 Sustained clinical remission [1]
    End point description
    The primary endpoint of the study was achieving sustained clinical remission, defined as disease activity outcome measure ASDAS-CRP <1.3 at two consequtive study visits with at least 12 week interval between them.
    End point type
    Primary
    End point timeframe
    From the initiation of the treatment protocol (=baseline) to week 52 visit of the trial.
    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: This trial has a single arm, therefore no comparative analyses are possible. The primary study endpoint - sustained clinical remission - is reported as percentage of patients achieving the endpoint.
    End point values
    		 NSAIDs With Possible Step-up to Golimumab
    Number of subjects analysed
    55 [2]
    Units: Patients achieving remission
    34
    Notes
    [2] - Number of patients who completed the study.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events data was collected between the first dose administration of trial medication and the last trial related activity. Medical events that occured between signing of the Informed Consent and the first intake of trial medication were documented a
    Adverse event reporting additional description
    All adverse events and serious adverse events were recorded in the patient's file and in the Case Report Form. Adverse Events were defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Included patients
    Reporting group description
    		 Patients included in the trial, for whom the treatment protocol was initiated.

    Serious adverse events
    		 Included patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 58 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Included patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 58 (32.76%)
    Infections and infestations
    Nasopharyngitis
    Additional description: Viral or bacterial upper respiratory tract infection, including confirmed SARS-CoV-2 infections.
         subjects affected / exposed
    14 / 58 (24.14%)
         occurrences all number
    16
    Gastroenteritis
    Additional description: Gastroenteritis of unspecified origin, self-limiting.
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Otitis media
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Sep 2017
    Clarification of the timing and analysis of stool sample collection.
    09 Oct 2019
    New trial center (Center 02) added: Reuma Institute Hasselt.
    15 Oct 2020
    Extension of the enrollment period.
    19 Jan 2021
    New trial center (Center 03) added: Imelda hospital Bonheiden. Additional medical examination in case if the baseline visit takes place more than 4 weeks after the screening visit.

    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 trial included 64 of initially anticipated 147 patients, what impacts downstream analyses powered for a larger group. The baseline prevalence of gut inflammation was lower than anticipated, therefore the primary objective could not be assessed.
    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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