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Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients (RA-MOBILITY)

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01061736
First received: February 2, 2010
Last updated: November 19, 2014
Last verified: November 2014

February 2, 2010
November 19, 2014
March 2010
October 2013   (final data collection date for primary outcome measure)
  • Part A: Percentage of patients who achieved the American College of Rheumatology score of 20% improvement (ACR20) at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Part B: Percentage of patients who achieved ACR20 response at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Part B: Change from baseline in modified Van der Heijde Sharp score (mTSS) at Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Composite index on X-ray assessed through central reading
  • Part B: Change from baseline in Health Assessment Question-Disability Index (HAQ-DI) at Week 16 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Part A: Percentage of patients who achieved the American College of Rheumatology criteria for improvement ACR20 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Part B: Percentage of patients who achieved ACR20 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01061736 on ClinicalTrials.gov Archive Site
Part B: Percentage of patients who achieved the American College of Rheumatology score of 70% improvement (ACR70) for at least 24 consecutive weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Part B: Change in modified Van der Heijde Sharp score (composite index on X-ray assessed through central reading). [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Part B: Change in physical function as measured by the change from baseline in the Health Assessment Question-Disability (HAQ_DI) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Part B: Percentage of patients who achieved and maintained (for at least 6 months) an ACR70 response [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients
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

Primary Objectives:

Part A (dose ranging study):

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

Part B (pivotal study):

To demonstrate that sarilumab added to MTX is 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 is 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 patients with active rheumatoid arthritis who are inadequate responders to MTX therapy.

The total study duration for a patient is 16-22 weeks (Part A) and 56-62 weeks (Part B) broken down as follows:

  • Screening: Up to 4 weeks
  • Treatment: 12 weeks (Part A) and 52 weeks (Part B)*
  • Follow-up: 6 weeks (for patients who will not continue in the long-term extension study).

'*' Patients successfully completing their treatment period will be offered the opportunity to enter the long term extension study LTS11210 (EXTEND).

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Sarilumab

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

    Other Names:
    • SAR153191
    • REGN88
  • Drug: Placebo (for sarilumab)

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • Drug: Methotrexate
    Same weekly dose as received prior to enrollment
  • Drug: Folic Acid
    According to local standard
  • Experimental: Part A: Sarilumab 100 mg qw + MTX
    Sarilumab 100 mg every week (qw) on top of Methotrexate (MTX) for 12 weeks
    Interventions:
    • Drug: Sarilumab
    • Drug: Methotrexate
    • Drug: Folic Acid
  • Experimental: Part A: Sarilumab 150 mg qw + MTX
    Sarilumab 150 mg every week (qw) on top of Methotrexate (MTX) for 12 weeks
    Interventions:
    • Drug: Sarilumab
    • Drug: Methotrexate
    • Drug: Folic Acid
  • Experimental: Part A: Sarilumab 100 mg q2w + MTX
    Sarilumab 100 mg every other week (q2w) alternating with placebo on top of Methotrexate (MTX) for 12 weeks
    Interventions:
    • Drug: Sarilumab
    • Drug: Placebo (for sarilumab)
    • Drug: Methotrexate
    • Drug: Folic Acid
  • Experimental: Part A: Sarilumab 150 mg q2w + MTX
    Sarilumab 150mg every other week (q2w) alternating with placebo on top of Methotrexate (MTX) for 12 weeks
    Interventions:
    • Drug: Sarilumab
    • Drug: Placebo (for sarilumab)
    • Drug: Methotrexate
    • Drug: Folic Acid
  • Experimental: Part A: Sarilumab 200 mg q2w + MTX
    Sarilumab 200mg every other week (q2w) alternating with placebo on top of Methotrexate (MTX) for 12 weeks
    Interventions:
    • Drug: Sarilumab
    • Drug: Placebo (for sarilumab)
    • Drug: Methotrexate
    • Drug: Folic Acid
  • Placebo Comparator: Part A: Placebo qw + MTX
    Placebo (for sarilumab) every week (qw) on top of Methotrexate (MTX) for 12 weeks
    Interventions:
    • Drug: Placebo (for sarilumab)
    • Drug: Methotrexate
    • Drug: Folic Acid
  • Experimental: Part B: Sarilumab 100 mg qw + MTX
    Sarilumab 100mg every week (qw) on top of Methotrexate (MTX) for 52 weeks
    Interventions:
    • Drug: Sarilumab
    • Drug: Methotrexate
    • Drug: Folic Acid
  • Experimental: Part B: Sarilumab 150 mg qw + MTX
    Sarilumab 150mg every week (qw) on top of Methotrexate (MTX) for 52 weeks
    Interventions:
    • Drug: Sarilumab
    • Drug: Methotrexate
    • Drug: Folic Acid
  • Experimental: Part B: Sarilumab 100 mg q2w + MTX
    Sarilumab 100mg every other week (q2w) alternating with placebo on top of Methotrexate (MTX) for 52 weeks
    Interventions:
    • Drug: Sarilumab
    • Drug: Placebo (for sarilumab)
    • Drug: Methotrexate
    • Drug: Folic Acid
  • Experimental: Part B: Sarilumab 150 mg q2w + MTX
    Sarilumab 150mg every other week (q2w) alternating with placebo on top of Methotrexate (MTX) for 52 weeks
    Interventions:
    • Drug: Sarilumab
    • Drug: Placebo (for sarilumab)
    • Drug: Methotrexate
    • Drug: Folic Acid
  • Experimental: Part B: Sarilumab 200 mg q2w + MTX
    Sarilumab 200mg every other week (q2w) alternating with placebo on top of Methotrexate (MTX) for 52 weeks
    Interventions:
    • Drug: Sarilumab
    • Drug: Placebo (for sarilumab)
    • Drug: Methotrexate
    • Drug: Folic Acid
  • Placebo Comparator: Part B: Placebo qw + MTX
    Placebo (for sarilumab) every week (qw) on top of Methotrexate (MTX) for 52 weeks
    Interventions:
    • Drug: Placebo (for sarilumab)
    • Drug: Methotrexate
    • Drug: Folic Acid

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1675
October 2013
October 2013   (final data collection date for primary outcome measure)

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

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 patient's potential participation in a clinical trial.

Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belarus,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   Czech Republic,   Egypt,   Estonia,   Finland,   Germany,   Greece,   Hungary,   India,   Korea, Republic of,   Lithuania,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Norway,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine
 
NCT01061736
EFC11072, 2009-016266-90
Yes
Not Provided
Not Provided
Sanofi
Sanofi
Regeneron Pharmaceuticals
Principal Investigator: Mark C Genovese, MD, Professor of Medicine Division of Immunonoly and Rheumatology - Stanford University - USA
Study Chair: TWJ Huizinga, Prof Dr Dpt of Rheumatology - Leiden University Medical Center - The Netherlands
Sanofi
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP