A Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Golimumab in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis Clinical Trial

Official title:

An Open-label Randomized Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of Subcutaneous and Intravenous Administrations of Golimumab to Subjects With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362153
• Other study ID #: CR015550
• Secondary ID: C0524T14
• Status: Completed
• Phase: Phase 1
• First received: March 10, 2011
• Last updated: September 28, 2017
• Start date: December 26, 2007
• Est. completion date: February 27, 2009

Study information

• Verified date: September 2017
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1, pharmacokinetic and pharmacodynamic study of intravenous and subcutaneous administered golimumab in patients with rheumatoid arthritis.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 27, 2009
• Est. primary completion date: February 27, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Have a diagnosis of RA for at least 3 months prior to screening

• Have no history of latent or active tuberculosis (TB) and test negative for TB

Exclusion Criteria:

• Have inflammatory diseases other than RA

• Have been treated with disease-modifying anti-rheumatic drugs (DMARDs)/systemic immunosuppressives other than methotrexate (MTX), sulfasalazine, or hydroxychloroquine during the 4 weeks prior to the first administration of study agent

• Have received intramuscular (IM), IV, or intra-articular corticosteroids within 4 weeks of study agent administration

• Have a known hypersensitivity to human Ig proteins

• Have received infliximab, golimumab, adalimumab or abatacept within 3 months, or etanercept or anakinra within 1 month prior to the first administration of study agent

• Have received alefacept, efalizumab, natalizumab, rituximab, or any B-cell-depleting agent

• Have been treated with any other biologics or investigational drugs, within 5 half-lives of that drug prior to the first administration of study agent

• Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis, prior to screening

• Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening

• Have had a serious infection (eg, hepatitis, pneumonia, pyelonephritis, or sepsis)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Golimumab
SC injection of 100 mg every 4 weeks through Week 20
• Golimumab
IV infusions of 2 mg/kg golimumab on Days 1 and 85.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK) (Cmax, AUClast, AUCinf, t1/2, systemic clearance, and volume of distribution) following IV administration		169 days
Primary	Pharmacokinetics (PK) [Cmax, tmax, AUC (0-4wk), t1/2 for last dose only, R[AUC(0-4wk)] following SC administration		211 days
Primary	Plasma concentrations of golimumab following IV administration		169 days
Primary	Plasma concentrations of golimumab following SC administration		211 days
Secondary	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		up to 211 days
Secondary	ACR (American College of Rheumatology) scores		up to 169 days
Secondary	The number and severity of adverse events		up to 211 days
Secondary	Efficacy as assessed by percent change in the American College of Rheumatology (ACR) score		up to 169 days

External Links

•   An Open-label Randomized Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of Subcutaneous and Intravenous Administrations of Golimumab to Subjects with Rheumatoid Arthritis