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RA-COMPARE: An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

Sponsor
Sanofi (Industry)
Overall Status
Terminated
CT.gov ID
NCT01764997
Collaborator
Regeneron Pharmaceuticals (Industry)
776
Enrollment
257
Locations
5
Arms
21
Duration (Months)
3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objective:

To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28).

Secondary Objectives:

To assess the signs and symptoms of RA in participants taking sarilumab in combination with MTX.

To assess the quality of life of participants with RA taking sarilumab in combination with MTX.

To assess the safety and tolerability of sarilumab in combination with MTX in participants with RA.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The maximum study duration per participant enrolled in the open label run-in phase and was eligible to enroll in the randomized phase of main study was 54 weeks:

  • open label screening period of up to 4 weeks

  • open-label treatment period of 16 weeks

  • randomized screening period of 2 to 4 weeks

  • randomized treatment post-treatment safety follow-up period of 6 weeks.

The maximum study duration per participant enrolled only in the open label run-in phase and was not eligible to enroll in the randomized phase of main study was 26 weeks:

  • open label screening period of up to 4 weeks

  • open-label treatment period of 16 weeks

  • open label treatment post-treatment safety follow-up period of 6 weeks.

The maximum study duration per participant enrolled in the open label run-in phase and was eligible to enroll in the sarilumab sub-study was 82 weeks:

  • open label screening period of up to 4 weeks

  • open-label treatment period of 16 weeks

  • screening period of 2 to 4 weeks

  • sarilumab treatment period of 52 weeks

  • sub-study post-treatment safety follow-up period of 6 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
776 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients With Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment With Adalimumab and MTX
Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adalimumab Open Label run-in

Adalimumab 40 mg every 2 weeks (Q2W) for 16 weeks added to stable dose of MTX.

Drug: Methotrexate
Dispensed according to local practice.

Drug: Adalimumab
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Active Comparator: Etanercept + MTX (Randomized)

Etanercept 50 mg in combination with Placebo for sarilumab Q2W and etanercept 50 mg on alternating weeks for 24 weeks added to stable dose of MTX.

Drug: Etanercept
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Other Names:
  • Enbrel

    • Drug: Methotrexate
    Dispensed according to local practice.

    Drug: Placebo (for sarilumab)
    Experimental: Sarilumab 150 mg + MTX (Randomized)

    Sarilumab 150 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.

    Drug: Sarilumab
    Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
    Other Names:
  • SAR153191
  • REGN88

    • Drug: Methotrexate
    Dispensed according to local practice.

    Drug: Placebo (for etanercept)
    Experimental: Sarilumab 200 mg + MTX (Randomized)

    Sarilumab 200 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.

    Drug: Sarilumab
    Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
    Other Names:
  • SAR153191
  • REGN88

    • Drug: Methotrexate
    Dispensed according to local practice.

    Drug: Placebo (for etanercept)
    Experimental: Sarilumab 150 mg + MTX Open Label Sub-study

    Sarilumab 150 mg Q2W for 52 weeks added to stable dose of MTX.

    Drug: Sarilumab
    Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
    Other Names:
  • SAR153191
  • REGN88

    • Drug: Methotrexate
    Dispensed according to local practice.

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Disease Activity Score for 28 Joints - C-Reactive Protein (DAS28-CRP) Score at Week 24 [Baseline, Week 24]

    Secondary Outcome Measures

    1. Number of Participants With at Least 20% Improvement in American College of Rheumatology (ACR20), at Least 50% Improvement in ACR (ACR50) and at Least 70% Improvement in ACR (ACR70) Efficacy Response Rates at Week 12 and Week 24 [Week 12 and Week 24]

    2. Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 12 and Week 24 [Week 12 and Week 24]

    3. Change From Baseline in DAS28-CRP Score at Week 12 [Baseline, Week 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • Diagnosis of RA >/= 3 months duration.

    • Continuous treatment of MTX 10 - 25 mg/week (or per local labeling requirements if the dose range differs) for at least 12 weeks before screening visit and on a stable dose for 8 weeks before screening visit.

    • Active disease defined as: at least 6/66 swollen and 8/68 tender joints and high sensitivity C-reactive protein > 10 mg/L.

    Exclusion criteria:

    • Age < 18 years.

    • Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks of the screening visit.

    • Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks of the screening visit.

    • Prior treatment with a tumor necrosis factor (TNF)-alpha inhibitor, or other biological disease modifying anti-rheumatoid drug (DMARD) or Janus Kinase inhibitor.

    • New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors within 4 weeks of the screening visit.

    • Treatment with traditional oral DMARD /immunosuppressive agents other than MTX within 4 weeks or 12 weeks before the screening visit, depending on DMARD.

    The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number 840004 Birmingham Alabama United States 35205
    2 Investigational Site Number 840212 Glendale California United States 91205
    3 Investigational Site Number 840211 Thousand Oaks California United States 91360
    4 Investigational Site Number 840049 Upland California United States 91786
    5 Investigational Site Number 840205 Victorville California United States 92395
    6 Investigational Site Number 840201 Denver Colorado United States 80230
    7 Investigational Site Number 840209 Danbury Connecticut United States 06810
    8 Investigational Site Number 840203 Washington, D.C. District of Columbia United States 20003
    9 Investigational Site Number 840210 Clearwater Florida United States 33756
    10 Investigational Site Number 840128 Ormond Beach Florida United States 32174
    11 Investigational Site Number 840063 Palm Harbor Florida United States 34684
    12 Investigational Site Number 840060 Sarasota Florida United States 34239
    13 Investigational Site Number 840207 Tampa Florida United States 33612
    14 Investigational Site Number 840018 Idaho Falls Idaho United States 83404
    15 Investigational Site Number 840213 Indianapolis Indiana United States 46250
    16 Investigational Site Number 840109 Lake Charles Louisiana United States 70601
    17 Investigational Site Number 840073 Cumberland Maryland United States 21502
    18 Investigational Site Number 840202 Hagerstown Maryland United States 21740
    19 Investigational Site Number 840204 Battle Creek Michigan United States 49015
    20 Investigational Site Number 840150 Lansing Michigan United States 48910
    21 Investigational Site Number 840200 Jackson Mississippi United States 39216
    22 Investigational Site Number 840037 Tupelo Mississippi United States 38801
    23 Investigational Site Number 840112 Lincoln Nebraska United States 68516
    24 Investigational Site Number 840056 New York New York United States 10016
    25 Investigational Site Number 840117 Pittsburgh Pennsylvania United States 15261
    26 Investigational Site Number 840016 North Charleston South Carolina United States 29406
    27 Investigational Site Number 840025 Jackson Tennessee United States 38305
    28 Investigational Site Number 840074 Mesquite Texas United States 75150
    29 Investigational Site Number 840061 Tacoma Washington United States 98405
    30 Investigational Site Number 840124 Clarksburg West Virginia United States 26301
    31 Investigational Site Number 032052 Buenos Aires Argentina C1015ABO
    32 Investigational Site Number 032050 Buenos Aires Argentina C1426AAL
    33 Investigational Site Number 032053 La Plata Argentina
    34 Investigational Site Number 032013 Rosario Argentina S200PBJ
    35 Investigational Site Number 032051 San Miguel De Tucumán Argentina
    36 Investigational Site Number 032005 Tucuman Argentina 4000
    37 Investigational Site Number 032009 Zarate Argentina B2800DGH
    38 Investigational Site Number 036020 Camperdown Australia 2050
    39 Investigational Site Number 036004 Heidelberg West Australia 3081
    40 Investigational Site Number 036014 Victoria Park Australia 6100
    41 Investigational Site Number 036007 Woodville Australia 5011
    42 Investigational Site Number 076001 Curitiba Brazil 80060-240
    43 Investigational Site Number 076016 Curitiba Brazil
    44 Investigational Site Number 076006 Goiania Brazil 74110-120
    45 Investigational Site Number 076010 Juiz De Fora Brazil 36010-570
    46 Investigational Site Number 076005 Rio De Janeiro Brazil 20551-030
    47 Investigational Site Number 076013 Vitoria Brazil 29055 450
    48 Investigational Site Number 152005 Osorno Chile 5311092
    49 Investigational Site Number 152018 Santiago Chile 7510047
    50 Investigational Site Number 152001 Santiago Chile
    51 Investigational Site Number 152002 Santiago Chile
    52 Investigational Site Number 152011 Santiago Chile
    53 Investigational Site Number 152015 Temuco Chile
    54 Investigational Site Number 170016 Bogota Colombia 0
    55 Investigational Site Number 170001 Bogota Colombia
    56 Investigational Site Number 170040 Bogotá Colombia NAP
    57 Investigational Site Number 170007 Bucaramanga Colombia
    58 Investigational Site Number 170009 Bucaramanga Colombia
    59 Investigational Site Number 170041 Medellin Colombia
    60 Investigational Site Number 203004 Ostrava Czechia 702 00
    61 Investigational Site Number 203001 Praha 2 Czechia 12850
    62 Investigational Site Number 203031 Praha 4 Czechia 14059
    63 Investigational Site Number 203033 Praha 4 Czechia 14800
    64 Investigational Site Number 203030 Praha 4 Czechia
    65 Investigational Site Number 203032 Praha Czechia 11000
    66 Investigational Site Number 203002 Uherske Hradiste Czechia 686 01
    67 Investigational Site Number 203006 Zlin Czechia 76001
    68 Investigational Site Number 218003 Cuenca Ecuador
    69 Investigational Site Number 218001 Guayaquil Ecuador 0593
    70 Investigational Site Number 218002 Quito Ecuador 0593
    71 Investigational Site Number 246001 Helsinki Finland 00290
    72 Investigational Site Number 246002 Hyvinkää Finland 05800
    73 Investigational Site Number 246030 Oulu Finland 90100
    74 Investigational Site Number 246003 Pori Finland 28100
    75 Investigational Site Number 246032 Tampere Finland
    76 Investigational Site Number 250003 Amiens Cedex 1 France 80054
    77 Investigational Site Number 250007 Bobigny France
    78 Investigational Site Number 250001 La Roche Sur Yon Cedex 9 France 85925
    79 Investigational Site Number 250002 Montpellier France 34295
    80 Investigational Site Number 250004 Paris Cedex 4 France 75181
    81 Investigational Site Number 250005 Paris France 74014
    82 Investigational Site Number 250006 Strasbourg France
    83 Investigational Site Number 250008 Toulouse France 31000
    84 Investigational Site Number 276007 Berlin Germany 12161
    85 Investigational Site Number 276057 Berlin Germany 12161
    86 Investigational Site Number 276056 Dresden Germany 01109
    87 Investigational Site Number 276055 Dresden Germany 01307
    88 Investigational Site Number 276051 Erlangen Germany 91056
    89 Investigational Site Number 276013 Hamburg Germany 22147
    90 Investigational Site Number 276001 Herne Germany 44649
    91 Investigational Site Number 276058 Koeln Germany
    92 Investigational Site Number 276053 Ludwigsfelde Germany 14974
    93 Investigational Site Number 276050 Rostock Germany
    94 Investigational Site Number 300010 Athens Greece 11527
    95 Investigational Site Number 300002 Heraklion Greece 71110
    96 Investigational Site Number 300014 N. Efkarpia Greece 56429
    97 Investigational Site Number 300012 Patras Greece
    98 Investigational Site Number 348001 Budapest Hungary 1023
    99 Investigational Site Number 348010 Debrecen Hungary 4031
    100 Investigational Site Number 348021 Esztergom Hungary 2500
    101 Investigational Site Number 348013 Gy?r Hungary 9025
    102 Investigational Site Number 348008 Gyula Hungary 5700
    103 Investigational Site Number 376032 Ashkelon Israel 78278
    104 Investigational Site Number 376001 Haifa Israel 31048
    105 Investigational Site Number 376010 Haifa Israel 31096
    106 Investigational Site Number 376031 Haifa Israel 34362
    107 Investigational Site Number 376035 Jerusalem Israel 91120
    108 Investigational Site Number 376030 Ramat Gan Israel 52621
    109 Investigational Site Number 376011 Tel Aviv Israel 64239
    110 Investigational Site Number 376034 Tel Hashomer Israel 52621
    111 Investigational Site Number 380002 Firenze Italy 50141
    112 Investigational Site Number 380004 Genova Italy 16011
    113 Investigational Site Number 380005 Genova Italy 16132
    114 Investigational Site Number 380041 L'Aquila Italy 67010
    115 Investigational Site Number 380042 Valeggio Sul Mincio Italy 37064
    116 Investigational Site Number 410020 Busan Korea, Republic of 602-715
    117 Investigational Site Number 410006 Busan Korea, Republic of 602-739
    118 Investigational Site Number 410013 Daegu Korea, Republic of 561-712
    119 Investigational Site Number 410005 Daejeon Korea, Republic of 301-721
    120 Investigational Site Number 410011 Jeonju Korea, Republic of 561-712
    121 Investigational Site Number 410016 Seoul Korea, Republic of 120-752
    122 Investigational Site Number 410015 Seoul Korea, Republic of 133-792
    123 Investigational Site Number 410022 Seoul Korea, Republic of 135-710
    124 Investigational Site Number 410023 Seoul Korea, Republic of 138-736
    125 Investigational Site Number 410021 Seoul Korea, Republic of 158-710
    126 Investigational Site Number 410008 Suwon Korea, Republic of 443-721
    127 Investigational Site Number 428002 Liepaja Latvia LV-3401
    128 Investigational Site Number 428001 Riga Latvia LV-1038
    129 Investigational Site Number 428003 Ventspils Latvia LV 3601
    130 Investigational Site Number 440005 Kaunas Lithuania LT-50009
    131 Investigational Site Number 440006 Klaipeda Lithuania LT-92288
    132 Investigational Site Number 440010 Panevezys Lithuania LT- 35144
    133 Investigational Site Number 440011 Vilnius Lithuania 08661
    134 Investigational Site Number 458012 Batu Caves Malaysia 68100
    135 Investigational Site Number 458014 Georgetown Malaysia 10990
    136 Investigational Site Number 458001 Ipoh Malaysia 30990
    137 Investigational Site Number 458013 Kota Bharu Malaysia 15586
    138 Investigational Site Number 458002 Kuching Malaysia 93586
    139 Investigational Site Number 458010 Melaka Malaysia 75400
    140 Investigational Site Number 458011 Seremban Malaysia 70300
    141 Investigational Site Number 484027 Cd. Obregon Mexico
    142 Investigational Site Number 484023 Chihuahua Mexico 31020
    143 Investigational Site Number 484029 Deleg. Benito Juárez Mexico 3100
    144 Investigational Site Number 484013 Guadalajara Mexico 44158
    145 Investigational Site Number 484018 Guadalajara Mexico 44620
    146 Investigational Site Number 484004 Merida Mexico 97000
    147 Investigational Site Number 484010 Mexicali Mexico 21200
    148 Investigational Site Number 484026 Mexicali Mexico 21200
    149 Investigational Site Number 484052 Mexico City Mexico 6726
    150 Investigational Site Number 484017 México Mexico 06700
    151 Investigational Site Number 484025 San Luis Mexico 78220
    152 Investigational Site Number 484051 Tijuana Mexico 22010
    153 Investigational Site Number 554007 Auckland New Zealand 1023
    154 Investigational Site Number 554010 Dunedin New Zealand 9016
    155 Investigational Site Number 554005 Hamilton New Zealand 3204
    156 Investigational Site Number 554011 Nelson New Zealand 1023
    157 Investigational Site Number 604001 Lima Peru 021
    158 Investigational Site Number 604010 Lima Peru 14
    159 Investigational Site Number 604009 Lima Peru LIMA 01
    160 Investigational Site Number 604012 Lima Peru LIMA 11
    161 Investigational Site Number 604007 Lima Peru Lima 33
    162 Investigational Site Number 604005 Lima Peru LIMA 41
    163 Investigational Site Number 604020 Lima Peru Lima36
    164 Investigational Site Number 616019 Bydgoszcz Poland 85-168
    165 Investigational Site Number 616054 Bytom Poland 41-902
    166 Investigational Site Number 616052 Dzialdowo Poland 13-200
    167 Investigational Site Number 616015 Elblag Poland
    168 Investigational Site Number 616057 Krakow Poland 31-121
    169 Investigational Site Number 616059 Krakow Poland 31-209
    170 Investigational Site Number 616061 Krakow Poland
    171 Investigational Site Number 616005 Lublin Poland 20-607
    172 Investigational Site Number 616063 Myslenice Poland 32-400
    173 Investigational Site Number 616018 Poznan Poland 61-397
    174 Investigational Site Number 616013 Sosnowiec Poland 41-200
    175 Investigational Site Number 616056 Starachowice Poland 27-200
    176 Investigational Site Number 616016 Szczecin Poland 71-252
    177 Investigational Site Number 616058 Ustron Poland 43-450
    178 Investigational Site Number 616051 Warszawa Poland 02-653
    179 Investigational Site Number 616053 Zyrardow Poland 96-300
    180 Investigational Site Number 642041 Bacau Romania
    181 Investigational Site Number 642012 Bucharest Romania 400006
    182 Investigational Site Number 642004 Bucharest Romania
    183 Investigational Site Number 642023 Bucharest Romania
    184 Investigational Site Number 642001 Bucuresti Romania 010976
    185 Investigational Site Number 642040 Bucuresti Romania 020125
    186 Investigational Site Number 642002 Bucuresti Romania 020983
    187 Investigational Site Number 642042 Bucuresti Romania
    188 Investigational Site Number 642005 Galati Romania 800578
    189 Investigational Site Number 642013 Iasi Romania 700127
    190 Investigational Site Number 642014 Iasi Romania 700656
    191 Investigational Site Number 642022 Targoviste Romania 130083
    192 Investigational Site Number 643006 Kemerovo Russian Federation 650099
    193 Investigational Site Number 643056 Krasnoyarsk Russian Federation 660022
    194 Investigational Site Number 643052 Moscow Russian Federation 117556
    195 Investigational Site Number 643021 Moscow Russian Federation 119049
    196 Investigational Site Number 643031 Moscow Russian Federation 121374
    197 Investigational Site Number 643030 Moscow Russian Federation 125284
    198 Investigational Site Number 643022 Novosibirsk Russian Federation 630091
    199 Investigational Site Number 643010 Samara Russian Federation 443095
    200 Investigational Site Number 643011 Saratov Russian Federation 410012
    201 Investigational Site Number 643059 Smolensk Russian Federation 214019
    202 Investigational Site Number 643008 St-Petersburg Russian Federation 192242
    203 Investigational Site Number 643058 St. Peterburg Russian Federation
    204 Investigational Site Number 643013 Ufa Russian Federation 450005
    205 Investigational Site Number 643050 Voronezh Russian Federation
    206 Investigational Site Number 643057 Yaroslavl Russian Federation 150003
    207 Investigational Site Number 643051 Yaroslavl Russian Federation
    208 Investigational Site Number 710011 Cape Town South Africa 7405
    209 Investigational Site Number 710007 Cape Town South Africa 7500
    210 Investigational Site Number 710008 Pretoria South Africa 0002
    211 Investigational Site Number 710006 Pretoria South Africa 0182
    212 Investigational Site Number 710010 Stellenbsoch South Africa 7600
    213 Investigational Site Number 724043 Córdoba Spain 14004
    214 Investigational Site Number 724009 La Coruña Spain 15006
    215 Investigational Site Number 724042 Madrid Spain 28034
    216 Investigational Site Number 724041 Madrid Spain 28046
    217 Investigational Site Number 724040 Madrid Spain 28850
    218 Investigational Site Number 724001 Málaga Spain 29009
    219 Investigational Site Number 724011 Sabadell Spain 08208
    220 Investigational Site Number 724012 Santiago De Compostela Spain 15705
    221 Investigational Site Number 158010 Changhua Taiwan 500
    222 Investigational Site Number 158004 Chia-Yi Taiwan 622
    223 Investigational Site Number 158012 Kaohsiung Taiwan 807
    224 Investigational Site Number 158011 Kaohsiung Taiwan 833
    225 Investigational Site Number 158006 Taipei Taiwan 402
    226 Investigational Site Number 764003 Bangkok-Noi Thailand
    227 Investigational Site Number 764002 Bangkok Thailand 10330
    228 Investigational Site Number 764010 Bangkok Thailand 10400
    229 Investigational Site Number 764011 Khon Kaen Thailand 40002
    230 Investigational Site Number 804003 Dnipropetrovsk Ukraine 49008
    231 Investigational Site Number 804002 Donetsk Ukraine 83114
    232 Investigational Site Number 804024 Donetsk Ukraine
    233 Investigational Site Number 804029 Ivano-Frankivsk Ukraine 76018
    234 Investigational Site Number 804010 Kharkiv Ukraine 61022
    235 Investigational Site Number 804001 Kharkov Ukraine 61057
    236 Investigational Site Number 804025 Kiev Ukraine 04114
    237 Investigational Site Number 804023 Kyiv Ukraine 01023
    238 Investigational Site Number 804014 Kyiv Ukraine 01103
    239 Investigational Site Number 804027 Kyiv Ukraine 03680
    240 Investigational Site Number 804011 Kyiv Ukraine
    241 Investigational Site Number 804030 Lutsk Ukraine 43024
    242 Investigational Site Number 804005 Lviv Ukraine 79005
    243 Investigational Site Number 804033 Lviv Ukraine 79010
    244 Investigational Site Number 804020 Lviv Ukraine 79013
    245 Investigational Site Number 804032 Odesa Ukraine 65025
    246 Investigational Site Number 804022 Odesa Ukraine 65026
    247 Investigational Site Number 804012 Odessa Ukraine 65117
    248 Investigational Site Number 804021 Simferopol Ukraine 95017
    249 Investigational Site Number 804028 Zaporozhye Ukraine 69118
    250 Investigational Site Number 804031 Zhytomyr Ukraine
    251 Investigational Site Number 826023 Barnsley United Kingdom
    252 Investigational Site Number 826022 Birmingham United Kingdom B15 2TH
    253 Investigational Site Number 826021 Dudley United Kingdom DY1 2HQ
    254 Investigational Site Number 826026 Durham United Kingdom
    255 Investigational Site Number 826027 Durham United Kingdom
    256 Investigational Site Number 826020 Harlow United Kingdom CM20 1QX
    257 Investigational Site Number 826025 Wigan United Kingdom WN6 9EP

    Sponsors and Collaborators

    • Sanofi
    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT01764997
    Other Study ID Numbers:
    • EFC11574
    • 2012-001984-66
    • U1111-1131-6653
    First Posted:
    Jan 10, 2013
    Last Update Posted:
    Jul 27, 2017
    Last Verified:
    Jun 1, 2017
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Adalimumab
    Etanercept
    Methotrexate

    Study Results

    Participant Flow

    Recruitment Details The study was conducted at 228 sites in 31 countries. A total of 1949 participants were screened between 09 May 2013 and 07 Aug 2014 of which 1173 participants were screen failures and a total of 776 participants entered in the adalimumab run-in phase of the study.
    Pre-assignment Detail Of 776 participants, 365 completed adalimumab run-in phase, of whom 43 non-responders randomized (1:1:1) in double-blind fashion to receive sarilumab 150 mg, sarilumab 200 mg or etanercept 50 mg; 322 responders entered in open label sub-study. 373 participants did not proceed into randomized phase or sub-study and 38 discontinued from run-in phase.
    Arm/Group Title Adalimumab Open Label run-in Etanercept + MTX (Randomized) Sarilumab 150 mg + MTX (Randomized) Sarilumab 200 mg + MTX (Randomized) Sarilumab 150 mg + MTX Open Label Sub-study
    Arm/Group Description Adalimumab 40 mg subcutaneous (SC) injection every 2 weeks (Q2W) for 16 weeks added to stable dose of methotrexate (MTX). Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX. Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. Sarilumab 150 mg SC injection Q2W for 52 weeks added to stable dose of MTX.
    Period Title: Run-in Period
    STARTED 776 0 0 0 0
    COMPLETED 738 0 0 0 0
    NOT COMPLETED 38 0 0 0 0
    Period Title: Run-in Period
    STARTED 0 17 13 13 322
    COMPLETED 0 16 13 13 286
    NOT COMPLETED 0 1 0 0 36

    Baseline Characteristics

    Arm/Group Title Adalimumab Open Label run-in Treatment Only Etanercept + MTX (Randomized) Sarilumab 150 mg + MTX (Randomized) Sarilumab 200 mg + MTX (Randomized) Sarilumab 150 mg + MTX Open Label Sub-study Total
    Arm/Group Description Adalimumab 40 mg SC injection Q2W for 16 weeks added to stable dose of MTX during run-in period. Participants who were not randomized in the main study or did not enter the sub-study were included in this arm for safety assessment. Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX. Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. Sarilumab 150 mg SC injection Q2W for 52 weeks added to stable dose of MTX. Total of all reporting groups
    Overall Participants 411 17 13 13 322 776
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    360
    87.6%
    14
    82.4%
    10
    76.9%
    10
    76.9%
    274
    85.1%
    668
    86.1%
    >=65 years
    51
    12.4%
    3
    17.6%
    3
    23.1%
    3
    23.1%
    48
    14.9%
    108
    13.9%
    Sex: Female, Male (Count of Participants)
    Female
    342
    83.2%
    15
    88.2%
    10
    76.9%
    9
    69.2%
    261
    81.1%
    637
    82.1%
    Male
    69
    16.8%
    2
    11.8%
    3
    23.1%
    4
    30.8%
    61
    18.9%
    139
    17.9%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Disease Activity Score for 28 Joints - C-Reactive Protein (DAS28-CRP) Score at Week 24
    Description
    Time Frame Baseline, Week 24

    Outcome Measure Data

    Analysis Population Description
    As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.
    Arm/Group Title Etanercept + MTX (Randomized) Sarilumab 150 mg + MTX (Randomized) Sarilumab 200 mg + MTX (Randomized)
    Arm/Group Description Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX. Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
    Measure Participants 0 0 0
    2. Secondary Outcome
    Title Number of Participants With at Least 20% Improvement in American College of Rheumatology (ACR20), at Least 50% Improvement in ACR (ACR50) and at Least 70% Improvement in ACR (ACR70) Efficacy Response Rates at Week 12 and Week 24
    Description
    Time Frame Week 12 and Week 24

    Outcome Measure Data

    Analysis Population Description
    As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.
    Arm/Group Title Etanercept + MTX (Randomized) Sarilumab 150 mg + MTX (Randomized) Sarilumab 200 mg + MTX (Randomized)
    Arm/Group Description Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX. Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
    Measure Participants 0 0 0
    3. Secondary Outcome
    Title Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 12 and Week 24
    Description
    Time Frame Week 12 and Week 24

    Outcome Measure Data

    Analysis Population Description
    As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.
    Arm/Group Title Etanercept + MTX (Randomized) Sarilumab 150 mg + MTX (Randomized) Sarilumab 200 mg + MTX (Randomized)
    Arm/Group Description Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX. Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
    Measure Participants 0 0 0
    4. Secondary Outcome
    Title Change From Baseline in DAS28-CRP Score at Week 12
    Description
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.
    Arm/Group Title Etanercept + MTX (Randomized) Sarilumab 150 mg + MTX (Randomized) Sarilumab 200 mg + MTX (Randomized)
    Arm/Group Description Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX. Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
    Measure Participants 0 0 0

    Adverse Events

    Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16 for run-in period and Week 58 for treatment period) regardless of seriousness or relationship to investigational product
    Adverse Event Reporting Description Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on-treatment period' (the time from the first dose of adalimumab to the end of follow-up period). All participants who entered open-label run-in period were included for safety assessment.
    Arm/Group Title Adalimumab Open Label run-in Etanercept + MTX (Randomized) Sarilumab 150 mg + MTX (Randomized) Sarilumab 200 mg + MTX (Randomized) Sarilumab 150 mg + MTX Open Label Sub-study
    Arm/Group Description Adalimumab 40 mg SC injection Q2W for 16 weeks added to stable dose of MTX. AEs in this group were those collected from signature of the informed consent form up to the end of Adalimumab treatment (Week 16). Etanercept 50 mg SC injection in combination with Placebo for sarilumab Q2W and etanercept 50 mg SC injection on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30). Sarilumab 150 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30). Sarilumab 200 mg SC injection in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX. AEs in this group were those collected post randomization up to the final visit (Week 30). Sarilumab 150 mg SC injection Q2W for 52 weeks added to stable dose of MTX. AEs in this group were those collected from enrollment in the sub-study up to the final visit (Week 58).
    All Cause Mortality
    Adalimumab Open Label run-in Etanercept + MTX (Randomized) Sarilumab 150 mg + MTX (Randomized) Sarilumab 200 mg + MTX (Randomized) Sarilumab 150 mg + MTX Open Label Sub-study
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Adalimumab Open Label run-in Etanercept + MTX (Randomized) Sarilumab 150 mg + MTX (Randomized) Sarilumab 200 mg + MTX (Randomized) Sarilumab 150 mg + MTX Open Label Sub-study
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 25/776 (3.2%) 2/17 (11.8%) 0/13 (0%) 0/13 (0%) 11/322 (3.4%)
    Blood and lymphatic system disorders
    Anaemia 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Neutropenia 0/776 (0%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 1/322 (0.3%)
    Cardiac disorders
    Angina unstable 0/776 (0%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 1/322 (0.3%)
    Atrial fibrillation 0/776 (0%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 1/322 (0.3%)
    Ear and labyrinth disorders
    Vertigo 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Eye disorders
    Blindness 0/776 (0%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 1/322 (0.3%)
    Gastrointestinal disorders
    Gastroduodenitis 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Haemorrhoidal haemorrhage 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Infections and infestations
    Arthritis bacterial 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Cellulitis 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Cholecystitis infective 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Colonic abscess 0/776 (0%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 1/322 (0.3%)
    Diverticulitis 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 1/322 (0.3%)
    Escherichia pyelonephritis 0/776 (0%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 1/322 (0.3%)
    Histoplasmosis disseminated 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Oral herpes 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Pneumonia 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Pyelonephritis 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Tuberculous pleurisy 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Urinary tract infection 0/776 (0%) 1/17 (5.9%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Viral parotitis 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Injury, poisoning and procedural complications
    Postoperative respiratory failure 0/776 (0%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 1/322 (0.3%)
    Spinal compression fracture 0/776 (0%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 1/322 (0.3%)
    Spinal fracture 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Tendon rupture 0/776 (0%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 1/322 (0.3%)
    Investigations
    Alanine aminotransferase increased 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Influenza B virus test positive 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Liver function test abnormal 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Metabolism and nutrition disorders
    Dehydration 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Musculoskeletal and connective tissue disorders
    Bursitis 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Osteoarthritis 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Rheumatoid arthritis 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Tenosynovitis 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer 0/776 (0%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 1/322 (0.3%)
    Intraductal proliferative breast lesion 0/776 (0%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 1/322 (0.3%)
    Neoplasm malignant 0/776 (0%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 1/322 (0.3%)
    Squamous cell carcinoma of skin 0/776 (0%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 1/322 (0.3%)
    Nervous system disorders
    Syncope 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Psychiatric disorders
    Suicide attempt 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Pulmonary embolism 0/776 (0%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 1/322 (0.3%)
    Skin and subcutaneous tissue disorders
    Angioedema 0/776 (0%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 1/322 (0.3%)
    Hypersensitivity vasculitis 0/776 (0%) 1/17 (5.9%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Vascular disorders
    Haematoma 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Hypertensive crisis 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Ischaemia 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Other (Not Including Serious) Adverse Events
    Adalimumab Open Label run-in Etanercept + MTX (Randomized) Sarilumab 150 mg + MTX (Randomized) Sarilumab 200 mg + MTX (Randomized) Sarilumab 150 mg + MTX Open Label Sub-study
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 132/776 (17%) 7/17 (41.2%) 7/13 (53.8%) 8/13 (61.5%) 104/322 (32.3%)
    Blood and lymphatic system disorders
    Neutropenia 2/776 (0.3%) 1/17 (5.9%) 1/13 (7.7%) 2/13 (15.4%) 33/322 (10.2%)
    Gastrointestinal disorders
    Abdominal tenderness 0/776 (0%) 1/17 (5.9%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Constipation 0/776 (0%) 0/17 (0%) 1/13 (7.7%) 0/13 (0%) 1/322 (0.3%)
    Diarrhoea 10/776 (1.3%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 5/322 (1.6%)
    Food poisoning 0/776 (0%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 1/322 (0.3%)
    Gastrooesophageal reflux disease 1/776 (0.1%) 0/17 (0%) 1/13 (7.7%) 0/13 (0%) 1/322 (0.3%)
    Nausea 8/776 (1%) 1/17 (5.9%) 0/13 (0%) 1/13 (7.7%) 3/322 (0.9%)
    Tooth disorder 0/776 (0%) 1/17 (5.9%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    General disorders
    Fatigue 3/776 (0.4%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 2/322 (0.6%)
    Injection site erythema 9/776 (1.2%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 15/322 (4.7%)
    Injection site pain 9/776 (1.2%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 3/322 (0.9%)
    Injection site pruritus 5/776 (0.6%) 1/17 (5.9%) 0/13 (0%) 0/13 (0%) 9/322 (2.8%)
    Injection site rash 6/776 (0.8%) 0/17 (0%) 1/13 (7.7%) 1/13 (7.7%) 7/322 (2.2%)
    Injection site swelling 0/776 (0%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 2/322 (0.6%)
    Peripheral swelling 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 0/322 (0%)
    Pyrexia 7/776 (0.9%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 1/322 (0.3%)
    Infections and infestations
    Body tinea 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 0/322 (0%)
    Hordeolum 2/776 (0.3%) 0/17 (0%) 1/13 (7.7%) 0/13 (0%) 0/322 (0%)
    Onychomycosis 0/776 (0%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 0/322 (0%)
    Pharyngitis 7/776 (0.9%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 3/322 (0.9%)
    Pharyngitis streptococcal 0/776 (0%) 0/17 (0%) 1/13 (7.7%) 0/13 (0%) 0/322 (0%)
    Rash pustular 1/776 (0.1%) 0/17 (0%) 1/13 (7.7%) 0/13 (0%) 0/322 (0%)
    Sinusitis 7/776 (0.9%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 5/322 (1.6%)
    Tinea versicolour 1/776 (0.1%) 0/17 (0%) 1/13 (7.7%) 0/13 (0%) 0/322 (0%)
    Upper respiratory tract infection 27/776 (3.5%) 1/17 (5.9%) 1/13 (7.7%) 1/13 (7.7%) 16/322 (5%)
    Urinary tract infection 16/776 (2.1%) 1/17 (5.9%) 0/13 (0%) 0/13 (0%) 4/322 (1.2%)
    Viral pharyngitis 0/776 (0%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 0/322 (0%)
    Injury, poisoning and procedural complications
    Accidental overdose 24/776 (3.1%) 0/17 (0%) 3/13 (23.1%) 0/13 (0%) 14/322 (4.3%)
    Chillblains 0/776 (0%) 1/17 (5.9%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Sunburn 0/776 (0%) 1/17 (5.9%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Investigations
    Alanine aminotransferase increased 5/776 (0.6%) 0/17 (0%) 0/13 (0%) 2/13 (15.4%) 11/322 (3.4%)
    Aspartate aminotransferase increased 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 3/322 (0.9%)
    Blood creatinine increased 0/776 (0%) 1/17 (5.9%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Neutrophil count decreased 0/776 (0%) 0/17 (0%) 1/13 (7.7%) 0/13 (0%) 4/322 (1.2%)
    Metabolism and nutrition disorders
    Hypokalaemia 0/776 (0%) 1/17 (5.9%) 0/13 (0%) 0/13 (0%) 1/322 (0.3%)
    Vitamin D deficiency 0/776 (0%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 1/322 (0.3%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 5/776 (0.6%) 1/17 (5.9%) 0/13 (0%) 0/13 (0%) 4/322 (1.2%)
    Costochondritis 0/776 (0%) 0/17 (0%) 1/13 (7.7%) 0/13 (0%) 1/322 (0.3%)
    Musculoskeletal pain 0/776 (0%) 0/17 (0%) 1/13 (7.7%) 0/13 (0%) 2/322 (0.6%)
    Osteoporotic fracture 0/776 (0%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 0/322 (0%)
    Pain in extremity 2/776 (0.3%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 2/322 (0.6%)
    Tenosynovitis stenosans 0/776 (0%) 1/17 (5.9%) 0/13 (0%) 0/13 (0%) 0/322 (0%)
    Nervous system disorders
    Tremor 0/776 (0%) 0/17 (0%) 1/13 (7.7%) 0/13 (0%) 0/322 (0%)
    Respiratory, thoracic and mediastinal disorders
    Paranasal sinus hypersecretion 0/776 (0%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 0/322 (0%)
    Sinus congestion 1/776 (0.1%) 0/17 (0%) 0/13 (0%) 1/13 (7.7%) 0/322 (0%)
    Skin and subcutaneous tissue disorders
    Dermatitis allergic 4/776 (0.5%) 1/17 (5.9%) 0/13 (0%) 0/13 (0%) 2/322 (0.6%)
    Pruritus 1/776 (0.1%) 0/17 (0%) 1/13 (7.7%) 0/13 (0%) 0/322 (0%)

    Limitations/Caveats

    The study was prematurely terminated due to small number of participants entering randomization.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.

    Results Point of Contact

    Name/Title Trial Transparency Team
    Organization Sanofi
    Phone
    Email Contact-US@sanofi.com
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT01764997
    Other Study ID Numbers:
    • EFC11574
    • 2012-001984-66
    • U1111-1131-6653
    First Posted:
    Jan 10, 2013
    Last Update Posted:
    Jul 27, 2017
    Last Verified:
    Jun 1, 2017