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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01061736




Registration number
NCT01061736
Ethics application status
Date submitted
2/02/2010
Date registered
3/02/2010
Date last updated
28/06/2017

Titles & IDs
Public title
Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients
Scientific title
A Randomized, Double-blind, Placebo-controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study With an Operationally Seamless Design, Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy
Secondary ID [1] 0 0
2009-016266-90
Secondary ID [2] 0 0
EFC11072
Universal Trial Number (UTN)
Trial acronym
RA-MOBILITY
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 - Placebo (for sarilumab)
Treatment: Drugs - Methotrexate
Treatment: Drugs - Folic Acid

Experimental: Part A: SAR 100 mg qw - Sarilumab 100 mg subcutaneous (SC) injection weekly (qw) on top of MTX for 12 weeks.

Experimental: Part A: SAR 150 mg qw - Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.

Experimental: Part A: SAR 100 mg q2w - Sarilumab 100 mg SC injection every other week (q2w) alternating with placebo on top of MTX for 12 weeks.

Experimental: Part A: SAR 150 mg q2w - Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.

Experimental: Part A: SAR 200 mg q2w - Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.

Placebo comparator: Part A: Placebo qw - Placebo (for sarilumab) qw on top of MTX for 12 weeks.

Experimental: Part B Cohort 1: Non-selected Doses - Sarilumab 100 mg qw, 150 mg qw or 100 mg q2w SC injections as in Part A on top of MTX up to dose selection. After dose selection, participants were not continued but were allowed to participate in the open-label, long-term, extension study SARIL-RA-EXTEND (LTS11210).

Experimental: Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2) - Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with open-label highest dose of sarilumab.

Experimental: Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2) - Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with open-label highest dose of sarilumab.

Experimental: Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2) - Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with open-label highest dose of sarilumab.


Treatment: Drugs: Sarilumab
Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Treatment: Drugs: Placebo (for sarilumab)
Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Treatment: Drugs: Methotrexate
Same weekly dose as received prior to enrollment

Treatment: Drugs: Folic Acid
According to local standard
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Timepoint [1] 0 0
Baseline to Week 12
Primary outcome [2] 0 0
Part B: Percentage of Participants Achieving ACR20 Response at Week 24
Timepoint [2] 0 0
Baseline to Week 24
Primary outcome [3] 0 0
Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16
Timepoint [3] 0 0
Baseline, Week 16
Primary outcome [4] 0 0
Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52
Timepoint [4] 0 0
Baseline, Week 52
Secondary outcome [1] 0 0
Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52
Timepoint [1] 0 0
Baseline up to Week 52

Eligibility
Key inclusion criteria
Inclusion criteria :

* Diagnosis of rheumatoid arthritis =3 months duration
* Active disease defined as:

* at least 8/68 tender joints and 6/66 swollen joints,
* high sensitivity C-reactive protein (hs-CRP) >6 mg/l,
* continuous treatment with MTX for at least 12 weeks prior to baseline visit and on stable dose for at least 6 weeks prior to screening visit.

Part B only:

* Bone erosion based on documented X-ray prior to first study drug intake, or
* Cyclic Citrullinated Peptide (CCP) positive, or
* Rheumatoid Factor (RF) positive.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Age <18 years or >75 years.
* Treatment with disease-modifying antirheumatic drugs (DMARDs) other than MTX within 4 weeks or 12 weeks prior to screening (depending on DMARDs).
* Past history of non-response to prior Tumor Necrosis Factor (TNF) or biologic treatment.
* Any past or current biologic agents for the treatment of rheumatoid arthritis within 3 months.
* Use of parenteral glucocorticoids or intraarticular glucocorticoids within 4 weeks prior to screening visit.
* Use of oral glucocorticoid greater than 10mg/day or equivalent/day, or a change in dosage within 4 weeks prior to baseline visit.

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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
1675
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036003 - Camperdown
Recruitment hospital [2] 0 0
Investigational Site Number 036005 - Clayton
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Investigational Site Number 036002 - East Malvern
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Investigational Site Number 036012 - Fitzroy
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Investigational Site Number 036010 - Garran
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Investigational Site Number 036004 - Heidelberg West
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Investigational Site Number 036009 - Herston
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Investigational Site Number 036001 - Maroochydore
Recruitment hospital [9] 0 0
Investigational Site Number 036006 - St Leonards
Recruitment hospital [10] 0 0
Investigational Site Number 036011 - Sydney
Recruitment hospital [11] 0 0
Investigational Site Number 036014 - Victoria Park
Recruitment hospital [12] 0 0
Investigational Site Number 036007 - Woodville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
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3168 - Clayton
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3145 - East Malvern
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3065 - Fitzroy
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2605 - Garran
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3081 - Heidelberg West
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4029 - Herston
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4558 - Maroochydore
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2065 - St Leonards
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2035 - Sydney
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6100 - Victoria Park
Recruitment postcode(s) [12] 0 0
5011 - Woodville
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Zaporizhzhia

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 Objectives:

Part A (dose ranging study):

To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks.

Part B (pivotal study):

To demonstrate that sarilumab added to MTX was effective in:

* reduction of signs and symptoms of rheumatoid arthritis at 24 weeks
* inhibition of progression of structural damage at 52 weeks
* improvement in physical function at 16 weeks

Secondary Objectives:

Part B:

To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks

To assess the safety of sarilumab added to MTX

To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.
Trial website
https://clinicaltrials.gov/study/NCT01061736
Trial related presentations / publications
Strand V, Kosinski M, Chen CI, Joseph G, Rendas-Baum R, Graham NM, van Hoogstraten H, Bayliss M, Fan C, Huizinga T, Genovese MC. Sarilumab plus methotrexate improves patient-reported outcomes in patients with active rheumatoid arthritis and inadequate responses to methotrexate: results of a phase III trial. Arthritis Res Ther. 2016 Sep 6;18(1):198. doi: 10.1186/s13075-016-1096-9.
Huizinga TW, Fleischmann RM, Jasson M, Radin AR, van Adelsberg J, Fiore S, Huang X, Yancopoulos GD, Stahl N, Genovese MC. Sarilumab, a fully human monoclonal antibody against IL-6Ralpha in patients with rheumatoid arthritis and an inadequate response to methotrexate: efficacy and safety results from the randomised SARIL-RA-MOBILITY Part A trial. Ann Rheum Dis. 2014 Sep;73(9):1626-34. doi: 10.1136/annrheumdis-2013-204405. Epub 2013 Dec 2.
Genovese MC, Fleischmann R, Kivitz AJ, Rell-Bakalarska M, Martincova R, Fiore S, Rohane P, van Hoogstraten H, Garg A, Fan C, van Adelsberg J, Weinstein SP, Graham NM, Stahl N, Yancopoulos GD, Huizinga TW, van der Heijde D. Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase III Study. Arthritis Rheumatol. 2015 Jun;67(6):1424-37. doi: 10.1002/art.39093.
Rubbert-Roth A, Furst DE, Fiore S, Praestgaard A, Bykerk V, Bingham CO, Charles-Schoeman C, Burmester G. Association between low hemoglobin, clinical measures, and patient-reported outcomes in patients with rheumatoid arthritis: results from post hoc analyses of three phase III trials of sarilumab. Arthritis Res Ther. 2022 Aug 25;24(1):207. doi: 10.1186/s13075-022-02891-x.
Rehberg M, Giegerich C, Praestgaard A, van Hoogstraten H, Iglesias-Rodriguez M, Curtis JR, Gottenberg JE, Schwarting A, Castaneda S, Rubbert-Roth A, Choy EHS; MOBILITY, MONARCH, TARGET, and ASCERTAIN investigators. Identification of a Rule to Predict Response to Sarilumab in Patients with Rheumatoid Arthritis Using Machine Learning and Clinical Trial Data. Rheumatol Ther. 2021 Dec;8(4):1661-1675. doi: 10.1007/s40744-021-00361-5. Epub 2021 Sep 14. Erratum In: Rheumatol Ther. 2021 Dec;8(4):1921-1922. doi: 10.1007/s40744-021-00389-7.
Genovese MC, Burmester GR, Hagino O, Thangavelu K, Iglesias-Rodriguez M, John GS, Gonzalez-Gay MA, Mandrup-Poulsen T, Fleischmann R. Interleukin-6 receptor blockade or TNFalpha inhibition for reducing glycaemia in patients with RA and diabetes: post hoc analyses of three randomised, controlled trials. Arthritis Res Ther. 2020 Sep 9;22(1):206. doi: 10.1186/s13075-020-02229-5.
Genovese MC, Fleischmann R, Kivitz A, Lee EB, van Hoogstraten H, Kimura T, St John G, Mangan EK, Burmester GR. Efficacy and safety of sarilumab in combination with csDMARDs or as monotherapy in subpopulations of patients with moderately to severely active rheumatoid arthritis in three phase III randomized, controlled studies. Arthritis Res Ther. 2020 Jun 10;22(1):139. doi: 10.1186/s13075-020-02194-z.
Boyapati A, Schwartzman S, Msihid J, Choy E, Genovese MC, Burmester GR, Lam G, Kimura T, Sadeh J, Weinreich DM, Yancopoulos GD, Graham NMH. Association of High Serum Interleukin-6 Levels With Severe Progression of Rheumatoid Arthritis and Increased Treatment Response Differentiating Sarilumab From Adalimumab or Methotrexate in a Post Hoc Analysis. Arthritis Rheumatol. 2020 Sep;72(9):1456-1466. doi: 10.1002/art.41299. Epub 2020 Aug 25.
Genovese MC, van der Heijde D, Lin Y, St John G, Wang S, van Hoogstraten H, Gomez-Reino JJ, Kivitz A, Maldonado-Cocco JA, Seriolo B, Stanislav M, Burmester GR. Long-term safety and efficacy of sarilumab plus methotrexate on disease activity, physical function and radiographic progression: 5 years of sarilumab plus methotrexate treatment. RMD Open. 2019 Aug 1;5(2):e000887. doi: 10.1136/rmdopen-2018-000887. eCollection 2019.
Muszbek N, Proudfoot C, Fournier M, Chen CI, Kuznik A, Kiss Z, Gal P, Michaud K. Economic Evaluation of Sarilumab in the Treatment of Adult Patients with Moderately-to-Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic Disease-Modifying Antirheumatic Drugs. Adv Ther. 2019 Jun;36(6):1337-1357. doi: 10.1007/s12325-019-00946-1. Epub 2019 Apr 19.
Boyapati A, Msihid J, Fiore S, van Adelsberg J, Graham NM, Hamilton JD. Sarilumab plus methotrexate suppresses circulating biomarkers of bone resorption and synovial damage in patients with rheumatoid arthritis and inadequate response to methotrexate: a biomarker study of MOBILITY. Arthritis Res Ther. 2016 Oct 6;18(1):225. doi: 10.1186/s13075-016-1132-9.
Public notes

Contacts
Principal investigator
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Mark C Genovese, MD, Professor of Medicine
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Division of Immunology and Rheumatology - Stanford University - USA
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Contact person for public queries
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01061736