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OpenTrials
Completed

NCT Number: NCT02404558

Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis

Primary Objective:

To describe the safety and tolerability, including laboratory abnormalities following a single dose of sarilumab or tocilizumab administered subcutaneously (SC) as monotherapy in Japanese patients with rheumatoid arthritis (RA).

Secondary Objectives:

To describe the laboratory abnormalities (absolute neutrophil count [ANC], platelet counts, total cholesterol, high-density lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL] cholesterol, and liver function tests [LFTs]) following a single dose of sarilumab or tocilizumab administered SC as monotherapy in Japanese patients with RA.

To describe the pharmacokinetics (PK) of sarilumab and tocilizumab.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number 392001, Sendai, Japan

Loading trial locations.

About this study

Total study duration (per patient) is expected to be up to 71 days including screening (3 to 28 days before dosing).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with rheumatoid arthritis (RA) as defined by the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010
  • Rheumatoid Arthritis Classification Criteria.
  • ACR Class I-III functional status, based on the 1991 revised criteria.

Exclusion criteria

  • Patients less than 20 years of age.
  • Prior treatment with any biologic anti-interleukin-6 (anti-IL-6) or interleukin-6 receptor (IL-6R) antagonist.
  • Any parenteral or intraarticular glucocorticoid injection within 4 weeks prior to randomization.
  • Treatment with prednisone higher than 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization.
  • Treatment with disease-modifying antirheumatic drugs (DMARDs), immunosuppressive agents, tumor necrosis factor (TNF) antagonists or any other RA-directed biologic agents within a certain amount of time prior to randomization.
  • 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 longer.
  • Active or suspected tuberculosis (TB) or at high risk of contracting TB.
  • Fever, or chronic, persistent, or recurring infection(s) requiring active treatment.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Sarilumab SAR153191 (REGN88)

Drug

Pharmaceutical form:solution Route of administration: Subcutaneous injection

Tocilizumab

Drug

Pharmaceutical form:solution Route of administration: Subcutaneous injection

Primary outcomes

  1. Percentage of patients with adverse events

    Time frame: 6 weeks

  2. Percentage of patients with potentially clinically significant laboratory abnormalities

    Time frame: 6 weeks

  3. Change from baseline in laboratory parameters (hematology and biochemistry)

    Time frame: Baseline, Day 15

  4. Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)

    Time frame: Baseline, Day 15

Secondary outcomes

  1. Assessment of PK parameter: maximum concentration (Cmax)

    Time frame: Day 1 to Day 43

  2. Assessment of PK parameter: time to Cmax (tmax)

    Time frame: Day 1 to Day 43

  3. Assessment of PK parameter: area under the curve from zero time until the last measurable concentration (AUClast)

    Time frame: Day 1 to Day 43

  4. Change from baseline in laboratory parameters (hematology and biochemistry)

    Time frame: Baseline, Day 29 and Day 43

  5. Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)

    Time frame: Baseline, Day 29 and Day 43

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

An Open-label, Randomized, Parallel Group, Single-dose Study to Describe the Safety of IL-6 Receptor Blockade With Sarilumab or Tocilizumab Monotherapy in Japanese Patients With Rheumatoid Arthritis

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 31, 2015
Registry last updated
Mar 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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