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A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists

Phase 3
18 Years
Open (Enrolling)
Rheumatoid Arthritis

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Trial Information

A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF 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.

Inclusion Criteria

Inclusion criteria:

- Diagnosis of RA, according to the American College of Rheumatology (ACR)/European
League against Rheumatism (EULAR) 2010 Rheumatoid Arthritis Classification Criteria
with ≥ 3 months disease duration.

- ACR Class I-III functional status, based on the 1991 revised criteria.

- Moderate-to-severely active RA.

- Anti-TNF therapy failures, defined as patients with an inadequate clinical response
defined by the investigator, after being treated for at least 3 consecutive months,
and/or intolerance to at least 1 anti-TNF, resulting in their discontinuation.
Anti-TNFs may include, but are not limited to, etanercept, infliximab, adalimumab,
golimumab and/or certolizumab pegol.

- Continuous treatment with one or a combination of non-biologic disease modifying
antirheumatic drugs (DMARDs) for at least 12 consecutive weeks prior to screening and
on a stable dose(s) for at least 6 consecutive weeks prior to screening:

- Methotrexate - 10 to 25 mg/wk orally or intra muscular (or per local labeling
requirements if the dose range differs)

- Leflunomide - 10 to 20 mg orally daily

- Sulfasalazine (SSZ) - 1000 to 3000 mg orally daily

- Hydroxychloroquine (HCQ) - 200 to 400 mg orally daily

Exclusion criteria:

- Patients <18 years of age.

- Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks
prior to screening.

- Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per
day, or a change in dosage within 4 weeks prior to screening.

- 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 systemic RA, including but not limited to vasculitis, pulmonary fibrosis,
and/or Felty's syndrome.

- Participation in any clinical research study that evaluated an investigational drug
or therapy within 5 half-lives or 60 days of the Screening Visit, whichever is

- Patients with active tuberculosis or latent tuberculosis infection.

- Prior or current history of interstitial lung disease.

- Prior treatment with anti-IL-6 or anti-IL-6R therapies, including but not limited to
tocilizumab or sarilumab.

- Treatment with anti-TNF agents, as follows:

- Etanercept: within 28 days prior to randomization

- Infliximab, adalimumab, golimumab, certolizumab pegol: within 42 days prior to

- Treatment with RA-directed biologic agents with non- TNF-α antagonist mechanisms
without adequate washout as follows:

- Anakinra: within 28 days prior to randomization

- Abatacept: within 42 days prior to randomization

- Rituximab or other cell depleting agent: Within 6 months prior to randomization
or until total lymphocyte count and CD 19+ lymphocyte count are normalized, or
whichever is longer.

- Prior treatment with a janus kinase (JAK) inhibitor (eg, tofacitinib).

- Patients with a history of invasive opportunistic infection.

- Prior or current history of malignancy, including lymphoproliferative diseases, 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.

- Prior or current history of other significant concomitant illness(es) that, according
to Investigator's judgment, would adversely affect the patient's participation in the

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

Type of Study:


Study Design:

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

Outcome Measure:

Safety as measured by adverse events/serious adverse events, physical examinations, clinical laboratory, ECGs.

Outcome Time Frame:

Up to 24 weeks

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

February 2015

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid



Investigational Site Number 840038 Austin, Texas  78705
Investigational Site Number 840048 Miami, Florida  33155
Investigational Site Number 840062 Reading, Pennsylvania  19611
Investigational Site Number 840022 Dallas, Texas  75235
Investigational Site Number 840152 Huntsville, Alabama  35801
Investigational Site Number 840151 Colorado Springs, Colorado  80910
Investigational Site Number 840153 Aventura, Florida  33180
Investigational Site Number 840155 Palm Harbor, Florida  34684
Investigational Site Number 840150 Lansing, Michigan  48910