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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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2009-016266-90
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Secondary ID [2]
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EFC11072
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Universal Trial Number (UTN)
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Trial acronym
RA-MOBILITY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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0
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
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Assessment method [1]
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ACR20 response was defined, based on guidelines set forth by the American College of Rheumatology (ACR), as =20 % improvement in tender joint count and swollen joint count as well as =20% improvement in at least 3 of 5 following measures: C-Reactive Protein (CRP), Participant assessment of pain; Participant's global assessment of disease activity; Physician global assessment of disease activity; and Health Assessment Question-Disability Index (HAQ-DI). Missing data imputed by Last Observation Carried Forward (LOCF).
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Timepoint [1]
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Baseline to Week 12
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Primary outcome [2]
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Part B: Percentage of Participants Achieving ACR20 Response at Week 24
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Assessment method [2]
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ACR20 improvement responses were determined without imputation of missing post-baseline values. In addition data collected after treatment discontinuation or rescue was set to missing. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.
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Timepoint [2]
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Baseline to Week 24
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Primary outcome [3]
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Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16
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Assessment method [3]
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HAQ-DI was a participant-reported questionnaire that assesses the difficulty of performing daily activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Overall score range from 0=least difficulty to 3=extreme difficulty. An increase in the score indicates a worsening of physical function while a decrease in the score represents improvement. Data collected after treatment discontinuation was set to missing.
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Timepoint [3]
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Baseline, Week 16
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Primary outcome [4]
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Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52
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Assessment method [4]
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The Sharp method modified by D. van der Heijde involves separate scores for erosions and joint space narrowing based on radiographs to assess the degree of structural damage. Total score range from 0 (normal) to 448 (worst possible total score). An increase in total score represents progression of structural damage. Missing data were imputed by the linear extrapolation method.
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Timepoint [4]
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Baseline, Week 52
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Secondary outcome [1]
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Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52
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Assessment method [1]
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Major clinical response was defined as an ACR70 response maintained for at least 24 consecutive weeks. ACR70 response uses the same criteria as for ACR20 but requires 70% improvement. In the primary approach, data collected after treatment discontinuation or rescue was set to missing. No imputation of missing post-baseline values was performed. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.
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Timepoint [1]
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Baseline up to Week 52
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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.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2013
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Sample size
Target
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Accrual to date
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Final
1675
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigational Site Number 036003 - Camperdown
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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
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Investigational Site Number 036006 - St Leonards
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Investigational Site Number 036011 - Sydney
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Investigational Site Number 036014 - Victoria Park
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Investigational Site Number 036007 - Woodville
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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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Recruitment postcode(s) [11]
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6100 - Victoria Park
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Recruitment postcode(s) [12]
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5011 - Woodville
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Incheon
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Jeonju
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Seoul
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Suwon
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Lithuania
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Kaunas
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Ipoh
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Kuching
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Malaysia
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Putrajaya
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Mexico
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Merida
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Mexico
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Mexico
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Mexico
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Heerlen
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Aveiro
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Braila
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Galati
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Ploiesti
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Russian Federation
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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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Russian Federation
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Russian Federation
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Russian Federation
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Saratov
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Russian Federation
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St-Petersburg
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Russian Federation
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Ufa
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Pretoria
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Barcelona
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Spain
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Sabadell
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Spain
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Spain
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Sevilla
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Linkou
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Izmir
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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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Kharkov
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Simferopol
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Ukraine
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Zaporizhzhia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Regeneron Pharmaceuticals
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01061736
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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.
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Public notes
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Contacts
Principal investigator
Name
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Mark C Genovese, MD, Professor of Medicine
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Address
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Division of Immunology and Rheumatology - Stanford University - USA
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01061736
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