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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT02404558
• Date of registration: 26/03/2015
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis
• Scientific 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
• Date of first enrolment: May 2015
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02404558
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Japan

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

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.



Age minimum: 20 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: sarilumab SAR153191 (REGN88)

Drug: tocilizumab

Primary Outcome(s)

Change from baseline in laboratory parameters (hematology and biochemistry) [Time Frame: Baseline, Day 15]

Weighted average of change from baseline in laboratory parameters (hematology and biochemistry) [Time Frame: Baseline, Day 15]

Percentage of patients with potentially clinically significant laboratory abnormalities [Time Frame: 6 weeks]

Percentage of patients with adverse events [Time Frame: 6 weeks]

Secondary Outcome(s)

Assessment of PK parameter: area under the curve from zero time until the last measurable concentration (AUClast) [Time Frame: Day 1 to Day 43]

Assessment of PK parameter: maximum concentration (Cmax) [Time Frame: Day 1 to Day 43]

Change from baseline in laboratory parameters (hematology and biochemistry) [Time Frame: Baseline, Day 29 and Day 43]

Assessment of PK parameter: time to Cmax (tmax) [Time Frame: Day 1 to Day 43]

Weighted average of change from baseline in laboratory parameters (hematology and biochemistry) [Time Frame: Baseline, Day 29 and Day 43]

Secondary ID(s)

PDY14191

U1111-1163-1359

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Regeneron Pharmaceuticals