This is a Phase 1, pharmacokinetic and pharmacodynamic study of intravenous and subcutaneous administered golimumab in patients with rheumatoid arthritis.
A Phase 1, randomized (study drug route of administration assigned by chance), open label (both physician and patient know that golimumab has been assigned), study of golimumab in patients with rheumatoid arthritis (RA). The purpose of this study is to compare the pharmacokinetic (how the body effects the drug) and pharmacodynamic (how the drug effects the body) effects of golimumab administered through a vein in the arm or by injection under the skin. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (eg, blood pressure), and the occurrence and severity of adverse events. The study will also assess the clinical effects of golimumab on RA. The study is planned for approximately 45 patients, which are randomized at a 2:1 ratio to receive golimumab SC or IV. Male or female patients who have been diagnosed with RA for at least 3 months and who are 18 years of age or older may be able to participate. Subcutaneous (SC) injections of 100 mg golimumab every 4 weeks through Week 20 or intravenous (IV) administrations of 2 mg/kg golimumab on Days 1 and 85.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Unnamed facility
Glendale, Arizona, United States
Unnamed facility
Aventura, Florida, United States
Unnamed facility
Palm Harbor, Florida, United States
Unnamed facility
Lexington, Kentucky, United States
Pharmacokinetics (PK) (Cmax, AUClast, AUCinf, t1/2, systemic clearance, and volume of distribution) following IV administration
Time frame: 169 days
Pharmacokinetics (PK) [Cmax, tmax, AUC (0-4wk), t1/2 for last dose only, R[AUC(0-4wk)] following SC administration
Time frame: 211 days
Plasma concentrations of golimumab following IV administration
Time frame: 169 days
Plasma concentrations of golimumab following SC administration
Time frame: 211 days
Pharmacodynamics (PD), including C-reactive protein, IL 6, serum amyloid A, tumor necrosis factor alpha, IL 18, E selectin, vascular endothelial growth factor, matrix metalloproteinases, leptin, and haptoglobin
Time frame: up to 211 days
ACR (American College of Rheumatology) scores
Time frame: up to 169 days
The number and severity of adverse events
Time frame: up to 211 days
Efficacy as assessed by percent change in the American College of Rheumatology (ACR) score
Time frame: up to 169 days
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Unnamed facility
Baton Rouge, Louisiana, United States
Unnamed facility
Worcester, Massachusetts, United States
Unnamed facility
Oklahoma City, Oklahoma, United States
Unnamed facility
Duncansville, Pennsylvania, United States
Unnamed facility
Houston, Texas, United States