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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
Recruitment hospital [3] 0 0
Investigational Site Number 036002 - East Malvern
Recruitment hospital [4] 0 0
Investigational Site Number 036012 - Fitzroy
Recruitment hospital [5] 0 0
Investigational Site Number 036010 - Garran
Recruitment hospital [6] 0 0
Investigational Site Number 036004 - Heidelberg West
Recruitment hospital [7] 0 0
Investigational Site Number 036009 - Herston
Recruitment hospital [8] 0 0
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
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3145 - East Malvern
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
2605 - Garran
Recruitment postcode(s) [6] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [7] 0 0
4029 - Herston
Recruitment postcode(s) [8] 0 0
4558 - Maroochydore
Recruitment postcode(s) [9] 0 0
2065 - St Leonards
Recruitment postcode(s) [10] 0 0
2035 - Sydney
Recruitment postcode(s) [11] 0 0
6100 - Victoria Park
Recruitment postcode(s) [12] 0 0
5011 - Woodville
Recruitment outside Australia
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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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark C Genovese, MD, Professor of Medicine
Address 0 0
Division of Immunology and Rheumatology - Stanford University - USA
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


Results are available at https://clinicaltrials.gov/study/NCT01061736