Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01764997




Registration number
NCT01764997
Ethics application status
Date submitted
8/01/2013
Date registered
10/01/2013
Date last updated
27/07/2017

Titles & IDs
Public title
An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate
Scientific 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
Secondary ID [1] 0 0
2012-001984-66
Secondary ID [2] 0 0
EFC11574
Universal Trial Number (UTN)
Trial acronym
RA-COMPARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sarilumab
Treatment: Drugs - Etanercept
Treatment: Drugs - Methotrexate
Treatment: Drugs - Adalimumab

Experimental: Adalimumab Open Label run-in - Adalimumab 40 mg every 2 weeks (Q2W) for 16 weeks added to stable dose of MTX.

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.

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.

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.

Experimental: Sarilumab 150 mg + MTX Open Label Sub-study - Sarilumab 150 mg Q2W for 52 weeks added to stable dose of MTX.


Treatment: Drugs: Sarilumab
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous

Treatment: Drugs: Etanercept
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous

Treatment: Drugs: Methotrexate
Dispensed according to local practice.

Treatment: Drugs: Adalimumab
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Disease Activity Score for 28 Joints - C-Reactive Protein (DAS28-CRP) Score at Week 24
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 12 and Week 24
Secondary outcome [2] 0 0
Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 12 and Week 24
Timepoint [2] 0 0
Week 12 and Week 24
Secondary outcome [3] 0 0
Change From Baseline in DAS28-CRP Score at Week 12
Timepoint [3] 0 0
Baseline, Week 12

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
Accrual to date
Final
776
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036020 - Camperdown
Recruitment hospital [2] 0 0
Investigational Site Number 036004 - Heidelberg West
Recruitment hospital [3] 0 0
Investigational Site Number 036014 - Victoria Park
Recruitment hospital [4] 0 0
Investigational Site Number 036007 - Woodville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [3] 0 0
6100 - Victoria Park
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
United States of America
State/province [20] 0 0
West Virginia
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
La Plata
Country [23] 0 0
Argentina
State/province [23] 0 0
Rosario
Country [24] 0 0
Argentina
State/province [24] 0 0
San Miguel De Tucumán
Country [25] 0 0
Argentina
State/province [25] 0 0
Tucuman
Country [26] 0 0
Argentina
State/province [26] 0 0
Zarate
Country [27] 0 0
Brazil
State/province [27] 0 0
Curitiba
Country [28] 0 0
Brazil
State/province [28] 0 0
Goiania
Country [29] 0 0
Brazil
State/province [29] 0 0
Juiz De Fora
Country [30] 0 0
Brazil
State/province [30] 0 0
Rio De Janeiro
Country [31] 0 0
Brazil
State/province [31] 0 0
Vitoria
Country [32] 0 0
Chile
State/province [32] 0 0
Osorno
Country [33] 0 0
Chile
State/province [33] 0 0
Santiago
Country [34] 0 0
Chile
State/province [34] 0 0
Temuco
Country [35] 0 0
Colombia
State/province [35] 0 0
Bogota
Country [36] 0 0
Colombia
State/province [36] 0 0
Bogotá
Country [37] 0 0
Colombia
State/province [37] 0 0
Bucaramanga
Country [38] 0 0
Colombia
State/province [38] 0 0
Medellin
Country [39] 0 0
Czechia
State/province [39] 0 0
Ostrava
Country [40] 0 0
Czechia
State/province [40] 0 0
Praha 2
Country [41] 0 0
Czechia
State/province [41] 0 0
Praha 4
Country [42] 0 0
Czechia
State/province [42] 0 0
Praha
Country [43] 0 0
Czechia
State/province [43] 0 0
Uherske Hradiste
Country [44] 0 0
Czechia
State/province [44] 0 0
Zlin
Country [45] 0 0
Ecuador
State/province [45] 0 0
Cuenca
Country [46] 0 0
Ecuador
State/province [46] 0 0
Guayaquil
Country [47] 0 0
Ecuador
State/province [47] 0 0
Quito
Country [48] 0 0
Finland
State/province [48] 0 0
Helsinki
Country [49] 0 0
Finland
State/province [49] 0 0
Hyvinkää
Country [50] 0 0
Finland
State/province [50] 0 0
Oulu
Country [51] 0 0
Finland
State/province [51] 0 0
Pori
Country [52] 0 0
Finland
State/province [52] 0 0
Tampere
Country [53] 0 0
France
State/province [53] 0 0
Amiens Cedex 1
Country [54] 0 0
France
State/province [54] 0 0
Bobigny
Country [55] 0 0
France
State/province [55] 0 0
La Roche Sur Yon Cedex 9
Country [56] 0 0
France
State/province [56] 0 0
Montpellier
Country [57] 0 0
France
State/province [57] 0 0
Paris Cedex 4
Country [58] 0 0
France
State/province [58] 0 0
Paris
Country [59] 0 0
France
State/province [59] 0 0
Strasbourg
Country [60] 0 0
France
State/province [60] 0 0
Toulouse
Country [61] 0 0
Germany
State/province [61] 0 0
Berlin
Country [62] 0 0
Germany
State/province [62] 0 0
Dresden
Country [63] 0 0
Germany
State/province [63] 0 0
Erlangen
Country [64] 0 0
Germany
State/province [64] 0 0
Hamburg
Country [65] 0 0
Germany
State/province [65] 0 0
Herne
Country [66] 0 0
Germany
State/province [66] 0 0
Koeln
Country [67] 0 0
Germany
State/province [67] 0 0
Ludwigsfelde
Country [68] 0 0
Germany
State/province [68] 0 0
Rostock
Country [69] 0 0
Greece
State/province [69] 0 0
Athens
Country [70] 0 0
Greece
State/province [70] 0 0
Heraklion
Country [71] 0 0
Greece
State/province [71] 0 0
N. Efkarpia
Country [72] 0 0
Greece
State/province [72] 0 0
Patras
Country [73] 0 0
Hungary
State/province [73] 0 0
Budapest
Country [74] 0 0
Hungary
State/province [74] 0 0
Debrecen
Country [75] 0 0
Hungary
State/province [75] 0 0
Esztergom
Country [76] 0 0
Hungary
State/province [76] 0 0
Gy?r
Country [77] 0 0
Hungary
State/province [77] 0 0
Gyula
Country [78] 0 0
Israel
State/province [78] 0 0
Ashkelon
Country [79] 0 0
Israel
State/province [79] 0 0
Haifa
Country [80] 0 0
Israel
State/province [80] 0 0
Jerusalem
Country [81] 0 0
Israel
State/province [81] 0 0
Ramat Gan
Country [82] 0 0
Israel
State/province [82] 0 0
Tel Aviv
Country [83] 0 0
Israel
State/province [83] 0 0
Tel Hashomer
Country [84] 0 0
Italy
State/province [84] 0 0
Firenze
Country [85] 0 0
Italy
State/province [85] 0 0
Genova
Country [86] 0 0
Italy
State/province [86] 0 0
L'Aquila
Country [87] 0 0
Italy
State/province [87] 0 0
Valeggio Sul Mincio
Country [88] 0 0
Korea, Republic of
State/province [88] 0 0
Busan
Country [89] 0 0
Korea, Republic of
State/province [89] 0 0
Daegu
Country [90] 0 0
Korea, Republic of
State/province [90] 0 0
Daejeon
Country [91] 0 0
Korea, Republic of
State/province [91] 0 0
Jeonju
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Seoul
Country [93] 0 0
Korea, Republic of
State/province [93] 0 0
Suwon
Country [94] 0 0
Latvia
State/province [94] 0 0
Liepaja
Country [95] 0 0
Latvia
State/province [95] 0 0
Riga
Country [96] 0 0
Latvia
State/province [96] 0 0
Ventspils
Country [97] 0 0
Lithuania
State/province [97] 0 0
Kaunas
Country [98] 0 0
Lithuania
State/province [98] 0 0
Klaipeda
Country [99] 0 0
Lithuania
State/province [99] 0 0
Panevezys
Country [100] 0 0
Lithuania
State/province [100] 0 0
Vilnius
Country [101] 0 0
Malaysia
State/province [101] 0 0
Batu Caves
Country [102] 0 0
Malaysia
State/province [102] 0 0
Georgetown
Country [103] 0 0
Malaysia
State/province [103] 0 0
Ipoh
Country [104] 0 0
Malaysia
State/province [104] 0 0
Kota Bharu
Country [105] 0 0
Malaysia
State/province [105] 0 0
Kuching
Country [106] 0 0
Malaysia
State/province [106] 0 0
Melaka
Country [107] 0 0
Malaysia
State/province [107] 0 0
Seremban
Country [108] 0 0
Mexico
State/province [108] 0 0
Cd. Obregon
Country [109] 0 0
Mexico
State/province [109] 0 0
Chihuahua
Country [110] 0 0
Mexico
State/province [110] 0 0
Deleg. Benito Juárez
Country [111] 0 0
Mexico
State/province [111] 0 0
Guadalajara
Country [112] 0 0
Mexico
State/province [112] 0 0
Merida
Country [113] 0 0
Mexico
State/province [113] 0 0
Mexicali
Country [114] 0 0
Mexico
State/province [114] 0 0
Mexico City
Country [115] 0 0
Mexico
State/province [115] 0 0
México
Country [116] 0 0
Mexico
State/province [116] 0 0
San Luis
Country [117] 0 0
Mexico
State/province [117] 0 0
Tijuana
Country [118] 0 0
New Zealand
State/province [118] 0 0
Auckland
Country [119] 0 0
New Zealand
State/province [119] 0 0
Dunedin
Country [120] 0 0
New Zealand
State/province [120] 0 0
Hamilton
Country [121] 0 0
New Zealand
State/province [121] 0 0
Nelson
Country [122] 0 0
Peru
State/province [122] 0 0
Lima
Country [123] 0 0
Poland
State/province [123] 0 0
Bydgoszcz
Country [124] 0 0
Poland
State/province [124] 0 0
Bytom
Country [125] 0 0
Poland
State/province [125] 0 0
Dzialdowo
Country [126] 0 0
Poland
State/province [126] 0 0
Elblag
Country [127] 0 0
Poland
State/province [127] 0 0
Krakow
Country [128] 0 0
Poland
State/province [128] 0 0
Lublin
Country [129] 0 0
Poland
State/province [129] 0 0
Myslenice
Country [130] 0 0
Poland
State/province [130] 0 0
Poznan
Country [131] 0 0
Poland
State/province [131] 0 0
Sosnowiec
Country [132] 0 0
Poland
State/province [132] 0 0
Starachowice
Country [133] 0 0
Poland
State/province [133] 0 0
Szczecin
Country [134] 0 0
Poland
State/province [134] 0 0
Ustron
Country [135] 0 0
Poland
State/province [135] 0 0
Warszawa
Country [136] 0 0
Poland
State/province [136] 0 0
Zyrardow
Country [137] 0 0
Romania
State/province [137] 0 0
Bacau
Country [138] 0 0
Romania
State/province [138] 0 0
Bucharest
Country [139] 0 0
Romania
State/province [139] 0 0
Bucuresti
Country [140] 0 0
Romania
State/province [140] 0 0
Galati
Country [141] 0 0
Romania
State/province [141] 0 0
Iasi
Country [142] 0 0
Romania
State/province [142] 0 0
Targoviste
Country [143] 0 0
Russian Federation
State/province [143] 0 0
Kemerovo
Country [144] 0 0
Russian Federation
State/province [144] 0 0
Krasnoyarsk
Country [145] 0 0
Russian Federation
State/province [145] 0 0
Moscow
Country [146] 0 0
Russian Federation
State/province [146] 0 0
Novosibirsk
Country [147] 0 0
Russian Federation
State/province [147] 0 0
Samara
Country [148] 0 0
Russian Federation
State/province [148] 0 0
Saratov
Country [149] 0 0
Russian Federation
State/province [149] 0 0
Smolensk
Country [150] 0 0
Russian Federation
State/province [150] 0 0
St-Petersburg
Country [151] 0 0
Russian Federation
State/province [151] 0 0
St. Peterburg
Country [152] 0 0
Russian Federation
State/province [152] 0 0
Ufa
Country [153] 0 0
Russian Federation
State/province [153] 0 0
Voronezh
Country [154] 0 0
Russian Federation
State/province [154] 0 0
Yaroslavl
Country [155] 0 0
South Africa
State/province [155] 0 0
Cape Town
Country [156] 0 0
South Africa
State/province [156] 0 0
Pretoria
Country [157] 0 0
South Africa
State/province [157] 0 0
Stellenbsoch
Country [158] 0 0
Spain
State/province [158] 0 0
Córdoba
Country [159] 0 0
Spain
State/province [159] 0 0
La Coruña
Country [160] 0 0
Spain
State/province [160] 0 0
Madrid
Country [161] 0 0
Spain
State/province [161] 0 0
Málaga
Country [162] 0 0
Spain
State/province [162] 0 0
Sabadell
Country [163] 0 0
Spain
State/province [163] 0 0
Santiago De Compostela
Country [164] 0 0
Taiwan
State/province [164] 0 0
Changhua
Country [165] 0 0
Taiwan
State/province [165] 0 0
Chia-Yi
Country [166] 0 0
Taiwan
State/province [166] 0 0
Kaohsiung
Country [167] 0 0
Taiwan
State/province [167] 0 0
Taipei
Country [168] 0 0
Thailand
State/province [168] 0 0
Bangkok-Noi
Country [169] 0 0
Thailand
State/province [169] 0 0
Bangkok
Country [170] 0 0
Thailand
State/province [170] 0 0
Khon Kaen
Country [171] 0 0
Ukraine
State/province [171] 0 0
Dnipropetrovsk
Country [172] 0 0
Ukraine
State/province [172] 0 0
Donetsk
Country [173] 0 0
Ukraine
State/province [173] 0 0
Ivano-Frankivsk
Country [174] 0 0
Ukraine
State/province [174] 0 0
Kharkiv
Country [175] 0 0
Ukraine
State/province [175] 0 0
Kharkov
Country [176] 0 0
Ukraine
State/province [176] 0 0
Kiev
Country [177] 0 0
Ukraine
State/province [177] 0 0
Kyiv
Country [178] 0 0
Ukraine
State/province [178] 0 0
Lutsk
Country [179] 0 0
Ukraine
State/province [179] 0 0
Lviv
Country [180] 0 0
Ukraine
State/province [180] 0 0
Odesa
Country [181] 0 0
Ukraine
State/province [181] 0 0
Odessa
Country [182] 0 0
Ukraine
State/province [182] 0 0
Simferopol
Country [183] 0 0
Ukraine
State/province [183] 0 0
Zaporozhye
Country [184] 0 0
Ukraine
State/province [184] 0 0
Zhytomyr
Country [185] 0 0
United Kingdom
State/province [185] 0 0
Barnsley
Country [186] 0 0
United Kingdom
State/province [186] 0 0
Birmingham
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Dudley
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Durham
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Harlow
Country [190] 0 0
United Kingdom
State/province [190] 0 0
Wigan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01764997
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01764997