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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02121210
• Date of registration: 21/04/2014
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA) SARIL-RA-ONE
• Scientific title: An Open-label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid Arthritis
• Date of first enrolment: June 2014
• Target sample size: 132
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02121210
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Chile, Czech Republic, Czechia, Estonia, Hungary, Poland, Russian Federation, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: sarilumab SAR153191 (REGN88)

Primary Outcome(s)

Percentage of Participants With Incidence of Antidrug Antibodies (ADA) [Time Frame: From Baseline to Week 30 [End of study (EOS)]]

Secondary Outcome(s)

Serum Sarilumab Concentration [Time Frame: Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30]

Secondary ID(s)

U1111-1143-4344

2013-002790-22

EFC13752

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Regeneron Pharmaceuticals

Results

• Results available: Yes
• Date Posted: 20/06/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02121210