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    Clinical Trial Results:
    A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSION RETRO – REduction of Therapy in RA patients in Ongoing remission, Reduzierung der Therapie bei RA-Patienten in Remission

    Summary
    EudraCT number
    		 2009-015740-42
    Trial protocol
    		 DE  
    Global end of trial date
    15 Jul 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Aug 2021
    First version publication date
    21 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UKER00109STUM3
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Erlangen
    Sponsor organisation address
    Maximiliansplatz 2, Erlangen, Germany,
    Public contact
    PD Dr. med. Jürgen Rech, Medizinische Klinik 3, Universitätsklinikum Erlangen, juergen.rech@uk-erlangen.de
    Scientific contact
    PD Dr. med. Jürgen Rech, Medizinische Klinik 3, Universitätsklinikum Erlangen, juergen.rech@uk-erlangen.de
    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
    15 Jul 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jul 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The current concept of RA-therapy is remission, which is defined by reaching a disease activity score counted in 28 joints of the body (DAS 28) of less than 2,6 as a main target. Rheumatoid Arthritis nowadays is being treated increasingly successful, due to better treatment with standard medications (dosage until limit, combination of therapies), due to quicker and more flexible therapy schemes (early start of treatment, close mashed therapy monitoring and due to introduction of new preparations. About 30% of RA patients reach clinical remission of RA. Yet it is still unclear, if and for how long a patient in long lasting and stable remission is to continue therapy or whether it is possible to reduce medication without risking a relapse of the disease. This study means on one hand to examine the possibility of a reduction of therapy or even a breaking off therapy in RA patients in long lasting remission.
    Protection of trial subjects
    Regular lab controls, clinical visits every 3 months, continous documentation and evaluation of AEs
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 May 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
    Germany: 258
    Worldwide total number of subjects
    258
    EEA total number of subjects
    258
    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)
    201
    From 65 to 84 years
    57
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 286 patients were screened at 13 centers. Due to screening failures, withdrawal of IC etc. 258 data sets were available

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control
    Arm description
    		 continuation of treatment
    Arm type
    		 IMP full dose

    Investigational medicinal product name
    RA treatment with corticosteroids, cDMARDs, bDMARDs (TNF inhibitors, IL-6 inhibitors, IL-1 inhibitors)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet, Concentrate for solution for infusion, Solution for infusion, Solution for injection, Solution for injection in pre-filled injector, Solution for injection in pre-filled syringe, Tablet
    Routes of administration
    Concentrate for solution for infusion , Injection , Infusion , Oral use
    Dosage and administration details
    full dose according to SmPC

    Arm title
    		 Reduction
    Arm description
    		 50% reduction of RA-treatment
    Arm type
    		 IMP 50% dose

    Investigational medicinal product name
    RA treatment with corticosteroids, cDMARDs, bDMARDs (TNF inhibitors, IL-6 inhibitors, IL-1 inhibitors)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet, Concentrate for solution for infusion, Solution for infusion, Solution for injection, Solution for injection in pre-filled injector, Solution for injection in pre-filled syringe, Tablet
    Routes of administration
    Concentrate for solution for infusion , Infusion , Injection , Oral use
    Dosage and administration details
    50% dose according to SmPC

    Arm title
    		 Reduction/stop
    Arm description
    		 50% reduction of IMP-treatment for 6 months followed by subsequent stopping of trewament when still in remission
    Arm type
    		 50% IMP+stop IMP

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Control Reduction Reduction/stop
    Started
    81
    85
    92
    Completed
    81
    85
    92
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Continuation
    Arm description
    		 Continuation of full dose RA-treatment
    Arm type
    		 Full dose IMP

    Investigational medicinal product name
    RA treatment with corticosteroids, cDMARDs, bDMARDs (TNF inhibitors, IL-6 inhibitors, IL-1 inhibitors)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet, Concentrate for solution for infusion, Solution for infusion, Solution for injection, Solution for injection in pre-filled injector, Solution for injection in pre-filled syringe, Tablet
    Routes of administration
    Concentrate for solution for infusion , Infusion , Injection , Oral use
    Dosage and administration details
    full dose according to SmPC

    Arm title
    		 Reduction
    Arm description
    		 50% reduction of RA-treatment
    Arm type
    		 50% reduction

    Investigational medicinal product name
    RA treatment with corticosteroids, cDMARDs, bDMARDs (TNF inhibitors, IL-6 inhibitors, IL-1 inhibitors)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion, Solution for infusion, Solution for injection, Solution for injection in pre-filled injector, Coated tablet, Solution for injection in pre-filled syringe, Tablet
    Routes of administration
    Infusion , Injection , Oral use, Concentrate for solution for infusion
    Dosage and administration details
    full dose according to SmPC

    Arm title
    		 Reduction/stop
    Arm description
    		 50% reduction of RA-treatment with subsequent stopping after 6 months when still in remission
    Arm type
    		 50% IMP+stop IMP

    Investigational medicinal product name
    RA treatment with corticosteroids, cDMARDs, bDMARDs (TNF inhibitors, IL-6 inhibitors, IL-1 inhibitors)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion, Solution for infusion, Solution for injection, Coated tablet, Solution for injection in pre-filled injector, Solution for injection in pre-filled syringe, Tablet
    Routes of administration
    Infusion , Injection , Oral use, Concentrate for solution for infusion
    Dosage and administration details
    full dose according to SmPC

    Number of subjects in period 2
    		Continuation Reduction Reduction/stop
    Started
    81
    85
    92
    Completed
    81
    85
    92

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control
    Reporting group description
    		 continuation of treatment

    Reporting group title
    Reduction
    Reporting group description
    		 50% reduction of RA-treatment

    Reporting group title
    Reduction/stop
    Reporting group description
    		 50% reduction of IMP-treatment for 6 months followed by subsequent stopping of trewament when still in remission

    Reporting group values
    		 Control Reduction Reduction/stop Total
    Number of subjects
    		 81 85 92 258
    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)
    		 57.3 ± 12.6 57.9 ± 12.8 57.0 ± 13.2 -
    Gender categorical
    Units: Subjects
        Female
    		 44 49 53 146
        Male
    		 37 36 39 112
    bDMARD use
    Units: Subjects
        yes
    		 32 39 37 108
        no
    		 49 46 55 150
    Rheumatoid factor
    Units: Subjects
        yes
    		 42 51 49 142
        no
    		 39 34 43 116
    ACPA positivity
    Units: Subjects
        yes
    		 47 49 52 148
        no
    		 34 36 40 110
    Methotrexate use
    Units: Subjects
        yes
    		 64 62 72 198
        no
    		 17 23 20 60
    other cDMARD
    Units: Subjects
        yes
    		 12 12 12 36
        no
    		 69 73 80 222
    Glucocorticoids use
    Units: Subjects
        yes
    		 15 15 14 44
        no
    		 66 70 78 214
    Disease duration
    Units: years
        arithmetic mean (standard deviation)
    		 7.2 ± 7.1 7.6 ± 7.1 6.8 ± 8.2 -
    Remission duration
    Units: months
        arithmetic mean (standard deviation)
    		 17.3 ± 13.8 14.5 ± 13.0 22.1 ± 30.8 -
    HAQ standard
    Units: points
        arithmetic mean (standard deviation)
    		 0.2 ± 0.4 0.2 ± 0.3 0.2 ± 0.4 -
    DAS28
    Units: unit(s)
        arithmetic mean (standard deviation)
    		 1.6 ± 0.7 1.6 ± 0.7 1.7 ± 0.6 -

    End points

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    End points reporting groups
    Reporting group title
    Control
    Reporting group description
    		 continuation of treatment

    Reporting group title
    Reduction
    Reporting group description
    		 50% reduction of RA-treatment

    Reporting group title
    Reduction/stop
    Reporting group description
    		 50% reduction of IMP-treatment for 6 months followed by subsequent stopping of trewament when still in remission
    Reporting group title
    Continuation
    Reporting group description
    		 Continuation of full dose RA-treatment

    Reporting group title
    Reduction
    Reporting group description
    		 50% reduction of RA-treatment

    Reporting group title
    Reduction/stop
    Reporting group description
    		 50% reduction of RA-treatment with subsequent stopping after 6 months when still in remission

    Primary: Remission

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    End point title
    		 Remission
    End point description
    proportion of subjects still remission after 12 months
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 Continuation Reduction Reduction/stop
    Number of subjects analysed
    81
    85
    92
    Units: subjects
    69
    50
    41
    Statistical analysis title
    		 Remission continuation vs reduction
    Comparison groups
    Continuation v Reduction
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From time of enrollment until visit 4 (month 12)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Control
    Reporting group description
    		 continuation of treatment

    Reporting group title
    Reduction
    Reporting group description
    		 50% reduction of RA-treatment

    Reporting group title
    Reduction/stop
    Reporting group description
    		 50% reduction of IMP-treatment for 6 months followed by subsequent stopping of trewament when still in remission

    Serious adverse events
    		 Control Reduction Reduction/stop
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 81 (12.35%)
    7 / 85 (8.24%)
    13 / 92 (14.13%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    1
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 92 (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
    Injury, poisoning and procedural complications
    Synovial rupture
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 92 (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
    Lower limb fracture
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 92 (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
    Procedural intestinal perforation
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Removal of internal fixation
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 92 (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
    Large intestinal polypectomy
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 92 (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
    Heart valve operation
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radical prostatectomy
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 92 (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
    Coronary arterial stent insertion
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myasthenia gravis crisis
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 92 (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
    Respiratory, thoracic and mediastinal disorders
    Pulmonary fibrosis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    2 / 81 (2.47%)
    0 / 85 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2.5%
    Non-serious adverse events
    		 Control Reduction Reduction/stop
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 81 (59.26%)
    55 / 85 (64.71%)
    45 / 92 (48.91%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Syncope
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    2 / 92 (2.17%)
         occurrences all number
    0
    0
    2
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 85 (2.35%)
    0 / 92 (0.00%)
         occurrences all number
    0
    2
    0
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    4 / 81 (4.94%)
    2 / 85 (2.35%)
    2 / 92 (2.17%)
         occurrences all number
    4
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    1 / 81 (1.23%)
    2 / 85 (2.35%)
    1 / 92 (1.09%)
         occurrences all number
    1
    2
    1
    Injury, poisoning and procedural complications
    Soft tissue injury
         subjects affected / exposed
    1 / 81 (1.23%)
    5 / 85 (5.88%)
    2 / 92 (2.17%)
         occurrences all number
    1
    5
    2
    Multiple injuries
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    2 / 92 (2.17%)
         occurrences all number
    0
    0
    2
    Rib fracture
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 85 (2.35%)
    0 / 92 (0.00%)
         occurrences all number
    0
    2
    0
    Radius fracture
         subjects affected / exposed
    2 / 81 (2.47%)
    0 / 85 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    0
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    1 / 81 (1.23%)
    3 / 85 (3.53%)
    3 / 92 (3.26%)
         occurrences all number
    3
    3
    4
    Carpal tunnel syndrome
         subjects affected / exposed
    2 / 81 (2.47%)
    0 / 85 (0.00%)
    2 / 92 (2.17%)
         occurrences all number
    3
    0
    2
    Migraine
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 85 (1.18%)
    1 / 92 (1.09%)
         occurrences all number
    1
    2
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 85 (2.35%)
    1 / 92 (1.09%)
         occurrences all number
    0
    2
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 81 (0.00%)
    3 / 85 (3.53%)
    1 / 92 (1.09%)
         occurrences all number
    0
    3
    1
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    3 / 81 (3.70%)
    1 / 85 (1.18%)
    0 / 92 (0.00%)
         occurrences all number
    3
    1
    0
    Colon adenoma
         subjects affected / exposed
    1 / 81 (1.23%)
    2 / 85 (2.35%)
    1 / 92 (1.09%)
         occurrences all number
    1
    2
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 81 (1.23%)
    2 / 85 (2.35%)
    2 / 92 (2.17%)
         occurrences all number
    1
    2
    2
    Pruritus
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    2 / 92 (2.17%)
         occurrences all number
    0
    0
    2
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    2 / 92 (2.17%)
         occurrences all number
    0
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 81 (6.17%)
    5 / 85 (5.88%)
    1 / 92 (1.09%)
         occurrences all number
    5
    4
    1
    Bursitis
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 85 (1.18%)
    1 / 92 (1.09%)
         occurrences all number
    1
    2
    1
    Synovial cyst
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    2 / 92 (2.17%)
         occurrences all number
    0
    0
    2
    Trigger finger
         subjects affected / exposed
    1 / 81 (1.23%)
    2 / 85 (2.35%)
    0 / 92 (0.00%)
         occurrences all number
    1
    2
    0
    Myalgia
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 85 (2.35%)
    0 / 92 (0.00%)
         occurrences all number
    0
    2
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    24 / 81 (29.63%)
    25 / 85 (29.41%)
    20 / 92 (21.74%)
         occurrences all number
    31
    43
    25
    Gastroenteritis
         subjects affected / exposed
    2 / 81 (2.47%)
    2 / 85 (2.35%)
    3 / 92 (3.26%)
         occurrences all number
    2
    2
    3
    Oral herpes
         subjects affected / exposed
    3 / 81 (3.70%)
    3 / 85 (3.53%)
    1 / 92 (1.09%)
         occurrences all number
    3
    3
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 81 (2.47%)
    2 / 85 (2.35%)
    1 / 92 (1.09%)
         occurrences all number
    2
    2
    1
    Sinusitis
         subjects affected / exposed
    1 / 81 (1.23%)
    2 / 85 (2.35%)
    1 / 92 (1.09%)
         occurrences all number
    1
    2
    1
    Soft tissue infection
         subjects affected / exposed
    1 / 81 (1.23%)
    2 / 85 (2.35%)
    2 / 92 (2.17%)
         occurrences all number
    1
    2
    2
    Conjunctivitis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    2 / 92 (2.17%)
         occurrences all number
    0
    0
    2
    Erysipelas
         subjects affected / exposed
    2 / 81 (2.47%)
    0 / 85 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    2
    0
    1
    Candida infection
         subjects affected / exposed
    2 / 81 (2.47%)
    0 / 85 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jun 2011
    participation of more centres; Restruction of ICF, actualisation of medication information
    12 Mar 2012
    wording in some protocol areas; wordings SAE=serious adverse event
    12 Nov 2012
    adress of Sponsor; participation of more centres; wording protocol; CCS Erlangen as central safety organization; personel changes
    16 Feb 2015
    Abatacept and Tocilizumab s.c. as study medication; wording of questionaaires; wording treament group-> reduction group; wording documents; timeline: May 2010-> app. 6/2022 (due to long-term observation)

    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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