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

NCT02121210 | Completed Phase 3 Results DMC

• 3 other identifiers: EFC137522013-002790-22U1111-1143-4344
• Study Type: interventional
• Target: 132
• Locations: 7 countries
• Sites: 28

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Incidence of Antidrug Antibodies (ADA)

  ADA to sarilumab and anti-sarilumab neutralizing antibodies in serum samples were determined using a validated electrochemiluminescence immunoassay method. Percentage of participants with positive ADA during treatment emergent adverse event (TEAE) period (time from first dose of investigational medicinal product \[IMP\] to last dose of IMP + 60 days) was determined. Persistent ADA Response: treatment-emergent ADA detected at 2 or more consecutive sampling time points during the TEAE period, where the first and last ADA positive samples were separated by a period of at least 16 weeks or if the last measured sample was positive. ADA samples were collected prior to IMP administration at Week 0 (baseline), Week 2, 4, 12, 24 and 30.

  From Baseline to Week 30 [End of study (EOS)]

Secondary Outcomes (1)

• Serum Sarilumab Concentration

  Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30

Study Arms (2)

Sarilumab 150 mg q2w

EXPERIMENTAL

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

Drug: sarilumab SAR153191 (REGN88)

Sarilumab 200 mg q2w

EXPERIMENTAL

Sarilumab 200 mg SC injection q2w for 24 weeks.

Drug: sarilumab SAR153191 (REGN88)

Interventions

sarilumab SAR153191 (REGN88) DRUG

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

Sarilumab 150 mg q2w; Sarilumab 200 mg q2w

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (28)

Investigational Site Number 840072

Gilbert, Arizona, 85234, United States

Location

Investigational Site Number 840049

Upland, California, 91786, United States

Location

Investigational Site Number 840220

South Miami, Florida, 33143, United States

Location

Investigational Site Number 840230

Elizabethtown, Kentucky, 42701, United States

Location

Investigational Site Number 840233

Minot, North Dakota, 58701, United States

Location

Investigational Site Number 840127

Oklahoma City, Oklahoma, 73103, United States

Location

Investigational Site Number 840011

Tulsa, Oklahoma, 74104, United States

Location

Investigational Site Number 840009

Duncansville, Pennsylvania, 16635, United States

Location

Investigational Site Number 840025

Jackson, Tennessee, 38305, United States

Location

Investigational Site Number 840032

Amarillo, Texas, 79124, United States

Location

Investigational Site Number 840074

Mesquite, Texas, 75150, United States

Location

Investigational Site Number 840124

Clarksburg, West Virginia, 26301, United States

Location

Investigational Site Number 840231

Franklin, Wisconsin, 53132, United States

Location

Investigational Site Number 152002

Santiago, 7501126, Chile

Location

Investigational Site Number 203034

Pardubice, 53002, Czechia

Location

Investigational Site Number 203001

Prague, 12850, Czechia

Location

Investigational Site Number 203002

Uherské Hradiště, 686 01, Czechia

Location

Investigational Site Number 233010

Tallinn, 10138, Estonia

Location

Investigational Site Number 233002

Tallinn, 13419, Estonia

Location

Investigational Site Number 348014

Budapest, 1027, Hungary

Location

Investigational Site Number 348025

Budapest, 1027, Hungary

Location

Investigational Site Number 348021

Esztergom, 2500, Hungary

Location

Investigational Site Number 616018

Poznan, 61-397, Poland

Location

Investigational Site Number 616031

Warsaw, 01-518, Poland

Location

Investigational Site Number 616012

Wroclaw, 50-044, Poland

Location

Investigational Site Number 643006

Kemerovo, 650000, Russia

Location

Investigational Site Number 643001

Moscow, 115522, Russia

Location

Investigational Site Number 643016

Ryazan, 390026, Russia

Location

Related Publications (1)

• 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.

  PMID: 31090044 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

sarilumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: April 23, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 20, 2017
• Results First Posted: June 20, 2017

Record last verified: 2017-05

Locations

US (13); HU (3); ES (2); CZ (3); PL (3); RU (3); CL (1)