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To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)
To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)

NCT02121210

CompletedPhase 3

Sponsor: Sanofi

Conditions: Rheumatoid Arthritis

Interventions: sarilumab SAR153191 (REGN88)

Countries: United States, Chile, Czechia, Estonia, Hungary, Poland, Russia

Primary Objective: To evaluate the immunogenicity of sarilumab administered as monotherapy. Secondary Objectives: * To evaluate the other safety aspects of sarilumab administered as monotherapy. * To assess the exposure of sarilumab administered as monotherapy.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria:

* Diagnosis of rheumatoid arthritis (RA) ≥ 3 months.
* Moderately to severely active rheumatoid arthritis.
* Participants who per investigator judgment were incomplete responders to at least 12 weeks of an adequate dose of continuous treatment with or who were intolerant of one or a combination of non-biologic disease modifying anti-rheumatic drugs (DMARDs).

Exclusion criteria:

* Participants \< 18 years of 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.
* Prior treatment with any biologic anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies.
* Treatment with prednisone \> 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization.
* New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors within 4 weeks prior to randomization, except for the use of low-dose acetylsalicylic acid for cardiovascular diseases.
* Use of parenteral glucocorticoids or intra-articular glucocorticoids injection within 4 weeks prior to randomization.
* Prior treatment with a Janus kinase (JAK) inhibitor (tofacitinib).
* New treatment or dose-adjustment to on-going medication for dyslipidemia, such as statin, within 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 dose of study drug administration, whichever is longer.
* Participants with a history of malignancy other than adequately-treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization visit. Non-malignant lymphoproliferative disorders are also excluded.
* Participants with active tuberculosis or untreated latent tuberculosis infection.
* Pregnant or breast feeding women.

The above information is not intended to contain all considerations relevant to a Participant's potential participation in a clinical trial.
Locations (28)
  • Gilbert, Arizona, United States
  • Upland, California, United States
  • South Miami, Florida, United States
  • Elizabethtown, Kentucky, United States
  • Minot, North Dakota, United States
  • Oklahoma City, Oklahoma, United States
  • Tulsa, Oklahoma, United States
  • Duncansville, Pennsylvania, United States
  • Jackson, Tennessee, United States
  • Amarillo, Texas, United States
  • Mesquite, Texas, United States
  • Clarksburg, West Virginia, United States
  • Franklin, Wisconsin, United States
  • Santiago, Chile
  • Pardubice, Czechia
  • Prague, Czechia
  • Uherské Hradiště, Czechia
  • Tallinn, Estonia
  • Tallinn, Estonia
  • Budapest, Hungary
  • Budapest, Hungary
  • Esztergom, Hungary
  • Poznan, Poland
  • Warsaw, Poland
  • Wroclaw, Poland
  • Kemerovo, Russia
  • Moscow, Russia
  • Ryazan, Russia