Trial Review

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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
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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Idaho
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United States of America
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Indiana
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United States of America
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Louisiana
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United States of America
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Maryland
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Michigan
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Mississippi
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Nebraska
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New York
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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Texas
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Washington
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West Virginia
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Argentina
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Buenos Aires
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Argentina
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La Plata
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Argentina
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Rosario
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Argentina
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San Miguel De Tucumán
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Tucuman
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Zarate
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Brazil
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Curitiba
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Brazil
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Goiania
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Brazil
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Juiz De Fora
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Brazil
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Rio De Janeiro
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Brazil
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Vitoria
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Chile
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Osorno
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Chile
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Santiago
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Chile
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Temuco
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Colombia
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Bogota
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Colombia
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Bogotá
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Bucaramanga
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Medellin
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Ostrava
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Praha 2
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Praha 4
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Czechia
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Praha
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Czechia
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Uherske Hradiste
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Czechia
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Zlin
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Ecuador
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Cuenca
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Ecuador
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Guayaquil
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Ecuador
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Quito
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Finland
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Helsinki
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Finland
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Hyvinkää
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Finland
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Oulu
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Finland
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Pori
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Finland
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Tampere
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France
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Amiens Cedex 1
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France
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Bobigny
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France
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La Roche Sur Yon Cedex 9
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France
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Montpellier
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France
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Paris Cedex 4
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France
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Paris
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France
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Strasbourg
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France
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Toulouse
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Erlangen
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Germany
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Hamburg
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Germany
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Herne
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Germany
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Koeln
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Germany
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Ludwigsfelde
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Germany
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Rostock
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Greece
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Athens
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Greece
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Heraklion
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Greece
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N. Efkarpia
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Greece
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Patras
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Esztergom
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Hungary
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Gy?r
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Hungary
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Gyula
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Israel
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Ashkelon
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Italy
State/province [84] 0 0
Firenze
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Italy
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Genova
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Italy
State/province [86] 0 0
L'Aquila
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Italy
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Valeggio Sul Mincio
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Korea, Republic of
State/province [88] 0 0
Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Jeonju
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Latvia
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Liepaja
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Riga
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Latvia
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Panevezys
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Lithuania
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Vilnius
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Malaysia
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Batu Caves
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Malaysia
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Georgetown
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Ipoh
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Kota Bharu
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Kuching
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Melaka
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Malaysia
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Seremban
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Mexico
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Cd. Obregon
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Mexico
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Chihuahua
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Mexico
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Deleg. Benito Juárez
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Mexico
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Merida
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Mexico
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Mexicali
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Mexico
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Mexico City
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Mexico
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México
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Mexico
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San Luis
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Mexico
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Tijuana
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New Zealand
State/province [118] 0 0
Auckland
Country [119] 0 0
New Zealand
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Dunedin
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New Zealand
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Hamilton
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New Zealand
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Nelson
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Peru
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Lima
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Poland
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Bydgoszcz
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Poland
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Bytom
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Poland
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Dzialdowo
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Poland
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Elblag
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Poland
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Krakow
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Lublin
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Myslenice
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Starachowice
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Ustron
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Warszawa
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Poland
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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
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Galati
Country [141] 0 0
Romania
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Iasi
Country [142] 0 0
Romania
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Targoviste
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Russian Federation
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Kemerovo
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Samara
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Russian Federation
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Saratov
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Russian Federation
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Smolensk
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Russian Federation
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St-Petersburg
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Russian Federation
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St. Peterburg
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Russian Federation
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Ufa
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Russian Federation
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Voronezh
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Russian Federation
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Yaroslavl
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South Africa
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Cape Town
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South Africa
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Pretoria
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South Africa
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Stellenbsoch
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Spain
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Córdoba
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Taiwan
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Changhua
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Taiwan
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Chia-Yi
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Taiwan
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Kaohsiung
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Taiwan
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Taipei
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Thailand
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Bangkok-Noi
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Thailand
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Bangkok
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Thailand
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Khon Kaen
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Ukraine
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Dnipropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kharkov
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Ukraine
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Kiev
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Ukraine
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Kyiv
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Ukraine
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Lutsk
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Odessa
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Ukraine
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Ukraine
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Zaporozhye
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Ukraine
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Zhytomyr
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United Kingdom
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Barnsley
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United Kingdom
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Birmingham
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United Kingdom
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Dudley
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United Kingdom
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Durham
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United Kingdom
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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01764997