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

NCT ID: NCT02121210

Last Updated: 2017-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-05-31

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]).

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sarilumab 150 mg q2w

Sarilumab 150 mg subcutaneous (SC) injection every two weeks (q2w) for 24 weeks.

Group Type: EXPERIMENTAL

sarilumab SAR153191 (REGN88)

Intervention Type: DRUG

Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous

Sarilumab 200 mg q2w

Sarilumab 200 mg SC injection q2w for 24 weeks.

Group Type: EXPERIMENTAL

sarilumab SAR153191 (REGN88)

Intervention Type: DRUG

Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous

Interventions

sarilumab SAR153191 (REGN88)

Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840072

Gilbert, Arizona, United States

Investigational Site Number 840049

Upland, California, United States

Investigational Site Number 840220

South Miami, Florida, United States

Investigational Site Number 840230

Elizabethtown, Kentucky, United States

Investigational Site Number 840233

Minot, North Dakota, United States

Investigational Site Number 840127

Oklahoma City, Oklahoma, United States

Investigational Site Number 840011

Tulsa, Oklahoma, United States

Investigational Site Number 840009

Duncansville, Pennsylvania, United States

Investigational Site Number 840025

Jackson, Tennessee, United States

Investigational Site Number 840032

Amarillo, Texas, United States

Investigational Site Number 840074

Mesquite, Texas, United States

Investigational Site Number 840124

Clarksburg, West Virginia, United States

Investigational Site Number 840231

Franklin, Wisconsin, United States

Investigational Site Number 152002

Santiago, , Chile

Investigational Site Number 203034

Pardubice, , Czechia

Investigational Site Number 203001

Prague, , Czechia

Investigational Site Number 203002

Uherské Hradiště, , Czechia

Investigational Site Number 233010

Tallinn, , Estonia

Investigational Site Number 233002

Tallinn, , Estonia

Investigational Site Number 348014

Budapest, , Hungary

Investigational Site Number 348025

Budapest, , Hungary

Investigational Site Number 348021

Esztergom, , Hungary

Investigational Site Number 616018

Poznan, , Poland

Investigational Site Number 616031

Warsaw, , Poland

Investigational Site Number 616012

Wroclaw, , Poland

Investigational Site Number 643006

Kemerovo, , Russia

Investigational Site Number 643001

Moscow, , Russia

Investigational Site Number 643016

Ryazan, , Russia

Countries

United States; Chile; Czechia; Estonia; Hungary; Poland; Russia

References

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.

Reference Type: DERIVED

PMID: 31090044 (View on PubMed)

Other Identifiers

2013-002790-22

Identifier Type: -

Identifier Source: secondary_id

U1111-1143-4344

Identifier Type: OTHER

Identifier Source: secondary_id

EFC13752

Identifier Type: -

Identifier Source: org_study_id