Sarilumab Effect on the Pharmacokinetics of Simvastatin

Completed · Phase 1

Conditions studied: Rheumatoid Arthritis

In brief

Primary Objective: To evaluate the effect of a single 200 mg subcutaneous injection of sarilumab on the pharmacokinetics of simvastatin in patients with rheumatoid arthritis Secondary Objective: To describe the safety and efficacy (exploratory) of sarilumab

Key facts

Study ID

NCT02017639

Run by

Sanofi

People needed

19

Starts

2014-01-01

Expected to finish

2016-03-01

Last updated by the study team

2016-04-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, between 18 and 75 years of age, inclusive. Body weight between 50.0 and 120.0 kg, inclusive, if male, and between 40.0 and 110.0 kg, inclusive, if female.
• Diagnosis of RA, according to the ACR/European League against Rheumatism (EULAR) 2010 Rheumatoid Arthritis Classification Criteria with ≥ 3 months disease duration, ACR Class I-III functional status, based on 1991 revised criteria (Appendix B, 5). Moderate-to-severely active RA, defined as:
• o high sensitivity C-reactive protein (hs-CRP) ≥ 6 mg/L
• Laboratory parameters within the normal range (or defined screening threshold for the Investigator site), unless the Investigator considers an abnormality to be clinically irrelevant for RA patients; however following lab values must be met:
• Hemoglobin >8.5 g/dL
• White blood cells >3000/mm3
• Neutrophils >2000/mm3
• Platelet count >150 000 cells/mm3

You may not qualify if…

• Prior or current significant concomitant illness(es) that, according to Investigator's judgment, would adversely affect the patient's participation in the study.
• Women of childbearing potential not protected by highly-effective contraceptive method(s) of birth control (as defined in the informed consent form), and/or who are unwilling or unable to be tested for pregnancy.
• Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the Screening, whichever is longer.
• Patients with active TB or a history of incompletely treated TB. History of chronic infection or active infection. History of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA.
• A systemic hypersensitivity reaction, other than localized injection site reaction, to any biologic drug.
• History or presence of drug or alcohol abuse. Prior or current interstitial lung disease diagnosed by high resolution computed tomography and/or lung biopsy with consistent findings on pulmonary function tests and corroborating clinical findings.
• Prior or current history of malignancy, including lymphoproliferative diseases, 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 screening visit.
• Uncontrolled diabetes mellitus, defined as glycosylated hemoglobin (HbA1c) ≥9% at the screening visit.
• Current treatment with anti-TNF agents or other biologics. Current treatment with RA-directed biologic agents with non- TNF-α antagonist. Any contra-indications to simvastatin, according to the applicable labeling. Current treatment with a statin within 14 days before inclusion.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840002 — Duncansville, Pennsylvania, United States
• Investigational Site Number 840003 — Jackson, Tennessee, United States
• Investigational Site Number 840001 — Dallas, Texas, United States
• Investigational Site Number 498001 — Chisinau, Moldova
• Investigational Site Number 410002 — Seoul, South Korea

Full record on ClinicalTrials.gov

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