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A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-α Antagonists


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Rheumatoid Arthritis

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Trial Information

A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-α Antagonists


Total study duration is up to 34 weeks: Screening up to 28 days, Treatment phase of 24
weeks, and post-treatment follow-up of 6 weeks. After completion of the treatment phase of
this study, patients are eligible to enter a long term safety study (LTS11210) for active
treatment wit SAR153191 (REGN88).

Inclusion Criteria


Inclusion criteria: Diagnosis of rheumatoid arthritis ≥6 months duration, according to the
American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010
Rheumatoid Arthritis Classification Criteria (1). ACR Class I-III functional status,
based on 1991 revised criteria (2). Anti-TNF therapy failures, defined by the
investigator as patients with an inadequate clinical response, after being treated for at
least 3 consecutive months, and/or intolerance to at least 1 anti-TNF blocker(s),
resulting in or requiring their discontinuation: TNF-blockers may include, but are
not limited to, etanercept, infliximab, adalimumab, golimumab and/or certolizumab.
Moderate-to-severely active rheumatoid arthritis. Continuous treatment with one or a
combination of DMARDs (except for simultaneous combination use of leflunomide and
methotrexate) for at least 12 weeks prior to baseline and on a stable dose(s) for at
least 6 weeks prior to screening: Methotrexate - 6 to 25 mg/wk orally or parenterally
Leflunomide - 10 to 20 mg orally daily Sulfasalazine - 1000 to 3000 mg orally daily
Hydroxychloroquine - 200 to 400 mg orally daily. Exclusion criteria: Patients <18 years
of age or legal adult age Past history of, or current, autoimmune or inflammatory
systemic or localized joint disease(s) other than RA. History of juvenile idiopathic
arthritis or arthritis onset prior to age 16. Severe active systemic RA, including but not
limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome. Treatment with
anti-TNF agents, as follows: o Within 28 days prior to the baseline visit - etanercept
o Within 42 days prior to the baseline visit - infliximab, adalimumab, golimumab,
certolizumab pegol Treatment with previous RA-directed biologic agents with other than
TNF antagonist mechanisms: o Within 28 days prior to the randomization (baseline) visit
- anakinra o Within 42 days prior to the randomization (baseline) visit - abatacept
Within 6 months prior to the randomization (baseline) visit - any cell depleting agents
including but not limited to rituximab without a normal lymphocyte and CD 19+ lymphocyte
count. Treatment with any DMARD other than those allowed per protocol and limited to the
maximum specified dosage within 12 weeks prior to baseline. Treatment with prednisone >10
mg or equivalent per day, or change in dosage within 4 weeks prior to baseline visit. Any
parenteral or intra-articular glucocorticoid injection within 4 weeks prior to baseline.
Prior treatment with anti-IL-6 or IL-6R antagonist therapies, including tocilizumab or
sarilumab, participation in a prior study of sarilumab, irrespective of treatment arm.
Prior treatment with a Janus kinase inhibitor (such as tofacitinib). New treatment or
dose-adjustment to ongoing medication for dyslipidemia within 6 weeks prior to
randomization, ie, stable dose for at least 6 weeks prior to randomization. Participation
in any clinical research study evaluating another investigational drug or therapy within 5
half-lives or 60 days of first investigational medicinal product (IMP) administration,
whichever is longer. History of alcohol or drug abuse within 5 years prior to the
screening visit. Patients with a history of malignancy other than adequately-treated
carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of
the skin, within 5 years prior to the randomization (baseline) visit. Nonmalignant
lymphoproliferative disorders are also excluded. Patients with active tuberculosis or
latent tuberculosis infection. The above information is not intended to contain all
considerations relevant to a patient's potential participation in a clinical trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

- The percentage of patients who achieved at least 20% improvement in the American College of Rheumatology (ACR) criteria

Outcome Time Frame:

At Week 24

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC10832

NCT ID:

NCT01709578

Start Date:

October 2012

Completion Date:

March 2015

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location

Investigational Site Number 840021Santa Maria, California  94354
Investigational Site Number 840011Tulsa, Oklahoma  74104
Investigational Site Number 840009Duncansville, Pennsylvania  16635
Investigational Site Number 840058Columbia, South Carolina  29204
Investigational Site Number 840025Jackson, Tennessee  38305
Investigational Site Number 840059Memphis, Tennessee  38119
Investigational Site Number 840070Anniston, Alabama  36207
Investigational Site Number 840138Birmingham, Alabama  35205
Investigational Site Number 840113Tucson, Arizona  
Investigational Site Number 840134Fullerton, California  92835
Investigational Site Number 840111La Jolla, California  92093
Investigational Site Number 840102Los Angeles, California  90017
Investigational Site Number 840135San Diego, California  92120
Investigational Site Number 840101Santa Barbara, California  93105
Investigational Site Number 840049Upland, California  91786
Investigational Site Number 840130Lewes, Delaware  19958
Investigational Site Number 840067Jupiter, Florida  33458
Investigational Site Number 840125Lake Mary, Florida  32746
Investigational Site Number 840048Miami, Florida  33155
Investigational Site Number 840024Naples, Florida  34102
Investigational Site Number 840128Ormond Beach, Florida  32174
Investigational Site Number 840063Palm Harbor, Florida  34684
Investigational Site Number 840060Sarasota, Florida  34239
Investigational Site Number 840126Vero Beach, Florida  32960
Investigational Site Number 840018Idaho Falls, Idaho  83404
Investigational Site Number 840052Kansas City, Kansas  66160-7321
Investigational Site Number 840015Lexington, Kentucky  40504
Investigational Site Number 840109Lake Charles, Louisiana  70601
Investigational Site Number 840055Frederick, Maryland  21702
Investigational Site Number 840137Grosse Pointe Woods, Michigan  48236
Investigational Site Number 840112Lincoln, Nebraska  
Investigational Site Number 840106Orchard Park, New York  
Investigational Site Number 840121Rochester, New York  
Investigational Site Number 840115Roslyn, New York  
Investigational Site Number 840118Smithtown, New York  
Investigational Site Number 840123Charlotte, North Carolina  28210
Investigational Site Number 840127Oklahoma City, Oklahoma  73103
Investigational Site Number 840117Pittsburgh, Pennsylvania  15213
Investigational Site Number 840062Reading, Pennsylvania  19611
Investigational Site Number 840122Knoxville, Tennessee  
Investigational Site Number 840136Allen, Texas  75013
Investigational Site Number 840022Dallas, Texas  75235
Investigational Site Number 840114El Paso, Texas  79902
Investigational Site Number 840129Houston, Texas  77074
Investigational Site Number 840133Houston, Texas  77008
Investigational Site Number 840074Mesquite, Texas  75150
Investigational Site Number 840103San Antonio, Texas  
Investigational Site Number 840119San Antonio, Texas  78232
Investigational Site Number 840124Clarksburg, West Virginia