To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA)

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2013-002790-22-HU
• Date of registration: 03/04/2014
• Prospective Registration: Yes
• Primary sponsor: sanofi-aventis recherche & développement
• Public title: To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA)
• 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 - SARIL-RA-ONE
• Date of first enrolment: 02/06/2014
• Target sample size: 120
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002790-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: two strengths for sarilumab Number of treatment arms in the trial: 2

Countries of recruitment

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

Contacts

• Name: NA.
• Affiliation: sanofi-aventis Zrt.

• Name: NA.
• Affiliation: sanofi-aventis Zrt.

Key inclusion & exclusion criteria

Inclusion criteria:
Diagnosis of rheumatoid arthitis RA = 3 months.
Moderately to severely active rheumatoid arthritis.
Patients 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 combnation of non-biologic disease modifying anti-rheumatic drugs (DMARDs).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion criteria:
Patients < 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 cardiovasculaire 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.
Patients with a history of malignancy 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 randimization visit. Nonmalignant lymphoproliferative disorders are also excluded.
Patients with active tuberculosis or untreated latent tuberculosis infection.
Pregnant or breast feeding women.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis
MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Sarilumab
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 131.6-

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Sarilumab
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 175-

Primary Outcome(s)

Primary end point(s): The incidence of anti-drug antibody (ADA) from baseline.

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

Main Objective: To evaluate the immunogenicity of sarilumab administered as monotherapy.

Timepoint(s) of evaluation of this end point: Up to 24 weeks.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Up to 24 weeks.

Secondary end point(s): Safety as assessed by adverse events/serious adverse events, vital signs, physical examinations, clinical laboratory, ECGs from baseline.
Sarilumab exposure assessed by pre-dose serum sarilumab concentrations from baseline.

Secondary ID(s)

EFC13752

Source(s) of Monetary Support

sanofi-aventis recherche et développement