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To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis (SARIL-RA-EASY)

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ClinicalTrials.gov Identifier: NCT02057250
Recruitment Status : Completed
First Posted : February 7, 2014
Results First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE January 31, 2014
First Posted Date  ICMJE February 7, 2014
Results First Submitted Date  ICMJE May 23, 2017
Results First Posted Date  ICMJE June 20, 2017
Last Update Posted Date June 20, 2017
Study Start Date  ICMJE March 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
Number of Validated AID Associated Product Technical Failures (PTFs) [ Time Frame: Baseline up to Week 12 ]
A PTF was defined as any product technical complaint (PTC) related to the use of the AID that had a validated technical cause. Each participant was given a diary having questions related to participant's ability to remove the cap, to start the injection, to complete the injection and regarding confirmation of completing the injection. Participants were asked to answer the questions each time they self-inject the sarilumab. If the response was "no" to any of the first 3 questions, this was considered as a PTC. The used AID, for which PTC was reported, was sent to sponsor, examined and evaluated for the occurrence of a PTF.
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
Number of Validated AID Associated Product Technical Failures (PTFs) [ Time Frame: Up to 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab [ Time Frame: Week 0-2: pre-dose on Day 1, anytime post-dose on Day 3, Day 5, Day 8, Day 12, Day 15; Week 10-12: pre-dose on Day 71, anytime post-dose on Day 73, Day 75, Day 78, Day 82, Day 85 ]
AUC(0-tau) is defined as area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval, where dose interval was 2 weeks. Serum concentrations of sarilumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of Sarilumab using the auto-injector (AID) versus the prefilled syringe (PFS) [ Time Frame: Up to 12 weeks (during the AID assessment phase) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis
Official Title  ICMJE A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy
Brief Summary

Primary Objective:

To collect real-use data of the sarilumab auto-injector device (AID) used by rheumatoid arthritis (RA) participants.

Secondary Objective:

To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus prefilled syringes (PFS).

Detailed Description

Total study duration up to 74 weeks: screening up to 4 weeks, AID assessment phase of 12 weeks, extension phase of 52 weeks and post-treatment follow-up of 6 weeks.

For participants not entering the extension phase, total study duration up to 22 weeks (screening, AID assessment phase and follow-up).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE RA
Intervention  ICMJE
  • Drug: Sarilumab
    Pharmaceutical form: Solution Route of administration: Subcutaneous
    Other Names:
    • SAR153191
    • REGN88
  • Device: Auto-Injector Device (AID)
  • Device: Pre-filled Syringe (PFS)
  • Drug: Methotrexate
    Dispensed according to local practice.
  • Drug: Sulfasalazine
    Dispensed according to local practice.
  • Drug: Leflunomide
    Dispensed according to local practice.
  • Drug: Hydroxychloroquine
    Dispensed according to local practice.
Study Arms  ICMJE
  • Experimental: Sarilumab 150 mg by AID
    Sarilumab 150 mg subcutaneous (SC) injection every 2 weeks (q2w) administered by AID with one or a combination of non-biologic disease-modifying anti-rheumatic drug (DMARD) (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.
    Interventions:
    • Drug: Sarilumab
    • Device: Auto-Injector Device (AID)
    • Drug: Methotrexate
    • Drug: Sulfasalazine
    • Drug: Leflunomide
    • Drug: Hydroxychloroquine
  • Experimental: Sarilumab 150 mg by PFS
    Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.
    Interventions:
    • Drug: Sarilumab
    • Device: Pre-filled Syringe (PFS)
    • Drug: Methotrexate
    • Drug: Sulfasalazine
    • Drug: Leflunomide
    • Drug: Hydroxychloroquine
  • Experimental: Sarilumab 200 mg by AID
    Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.
    Interventions:
    • Drug: Sarilumab
    • Device: Auto-Injector Device (AID)
    • Drug: Methotrexate
    • Drug: Sulfasalazine
    • Drug: Leflunomide
    • Drug: Hydroxychloroquine
  • Experimental: Sarilumab 200 mg by PFS
    Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.
    Interventions:
    • Drug: Sarilumab
    • Device: Pre-filled Syringe (PFS)
    • Drug: Methotrexate
    • Drug: Sulfasalazine
    • Drug: Leflunomide
    • Drug: Hydroxychloroquine
Publications * Kivitz A, Baret-Cormel L, van Hoogstraten H, Wang S, Parrino J, Xu C, Stanislav M. Usability and Patient Preference Phase 3 Study of the Sarilumab Pen in Patients with Active Moderate-to-Severe Rheumatoid Arthritis. Rheumatol Ther. 2018 Jun;5(1):231-242. doi: 10.1007/s40744-017-0090-2. Epub 2017 Dec 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2016)
217
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2014)
200
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Diagnosis of RA, ≥3 months disease duration;
  • Participant willing and able to self-inject;
  • Continuous treatment with 1 or a combination of non-biologic disease modifying antirheumatic drugs (DMARDs) (except leflunomide in combination with methotrexate);
  • Moderate-to-severely active RA.

Exclusion criteria:

  • Participants <18 years;
  • Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonists;
  • Treatment with tumor necrosis factor (TNF) antagonists;
  • Treatment with RA-directed biologic agents other than with a TNF-α antagonist mechanism as follows: Anakinra, Abatacept, Rituximab or other cell-depleting agent;
  • Prior treatment with a Janus kinase inhibitor.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   Mexico,   Poland,   Russian Federation,   South Africa,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT02057250
Other Study ID Numbers  ICMJE MSC12665
2012-004339-21
U1111-1130-9931 ( Other Identifier: UTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Regeneron Pharmaceuticals
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date May 2017

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