Clinical trial NCT02121210: To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)
Official title: An Open-label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2014-04-23
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Total study duration was up to 34 weeks: Up to 4-week screening period, 24-week open-label treatment phase, 6-week post-treatment observation. After completion of the treatment phase of this study, participants were eligible to enter a long term safety study (LTS11210 - SARIL-RA-EXTEND) for continuous treatment with sarilumab (SAR153191 \[REGN88\]).

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.

Primary outcomes:
measure: Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
timeFrame: From Baseline to Week 30 [End of study (EOS)]
Secondary outcomes:
measure: Serum Sarilumab Concentration
timeFrame: Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Investigational Site Number 840072
state: Arizona
city: Upland
country: United States
facility: Investigational Site Number 840049
state: California
city: South Miami
country: United States
facility: Investigational Site Number 840220
state: Florida
city: Elizabethtown
country: United States
facility: Investigational Site Number 840230
state: Kentucky
city: Minot
country: United States
facility: Investigational Site Number 840233
state: North Dakota
city: Oklahoma City
country: United States
facility: Investigational Site Number 840127
state: Oklahoma
city: Tulsa
country: United States
facility: Investigational Site Number 840011
state: Oklahoma
city: Duncansville
country: United States
facility: Investigational Site Number 840009
state: Pennsylvania
city: Jackson
country: United States
facility: Investigational Site Number 840025
state: Tennessee
city: Amarillo
country: United States
facility: Investigational Site Number 840032
state: Texas
city: Mesquite
country: United States
facility: Investigational Site Number 840074
state: Texas
city: Clarksburg
country: United States
facility: Investigational Site Number 840124
state: West Virginia
city: Franklin
country: United States
facility: Investigational Site Number 840231
state: Wisconsin
city: Santiago
country: Chile
facility: Investigational Site Number 152002
city: Pardubice
country: Czechia
facility: Investigational Site Number 203034
city: Praha 2
country: Czechia
facility: Investigational Site Number 203001
city: Uherske Hradiste
country: Czechia
facility: Investigational Site Number 203002
city: Tallinn
country: Estonia
facility: Investigational Site Number 233010
city: Tallinn
country: Estonia
facility: Investigational Site Number 233002
city: Budapest
country: Hungary
facility: Investigational Site Number 348014
city: Budapest
country: Hungary
facility: Investigational Site Number 348025
city: Esztergom
country: Hungary
facility: Investigational Site Number 348021
city: Poznan
country: Poland
facility: Investigational Site Number 616018
city: Warszawa
country: Poland
facility: Investigational Site Number 616031
city: Wroclaw
country: Poland
facility: Investigational Site Number 616012
city: Kemerovo
country: Russian Federation
facility: Investigational Site Number 643006
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643001
city: Ryazan
country: Russian Federation
facility: Investigational Site Number 643016
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Wells AF, Parrino J, Mangan EK, Paccaly A, Lin Y, Xu C, Fan C, Graham NMH, van Hoogstraten H, Torri A. Immunogenicity of Sarilumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Inadequate Responders or Intolerant to Disease-Modifying Antirheumatic Drugs. Rheumatol Ther. 2019 Sep;6(3):339-352. doi: 10.1007/s40744-019-0157-3. Epub 2019 May 14.