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

NCT ID: NCT01362153

Last Updated: 2017-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-26
• Study Completion Date: 2009-02-27

Brief Summary

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

Detailed 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.

Conditions

Rheumatoid Arthritis

Study Design

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

Study Groups

001

Golimumab IV infusions of 2 mg/kg golimumab on Days 1 and 85.

Group Type: EXPERIMENTAL

Golimumab

Intervention Type: DRUG

IV infusions of 2 mg/kg golimumab on Days 1 and 85.

002

Golimumab SC injection of 100 mg every 4 weeks through Week 20

Group Type: EXPERIMENTAL

Golimumab

Intervention Type: DRUG

SC injection of 100 mg every 4 weeks through Week 20

Interventions

Golimumab

SC injection of 100 mg every 4 weeks through Week 20

Intervention Type: DRUG

Golimumab

IV infusions of 2 mg/kg golimumab on Days 1 and 85.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Centocor, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Centocor, Inc.

Locations

Glendale, Arizona, United States

Aventura, Florida, United States

Palm Harbor, Florida, United States

Lexington, Kentucky, United States

Baton Rouge, Louisiana, United States

Worcester, Massachusetts, United States

Oklahoma City, Oklahoma, United States

Duncansville, Pennsylvania, United States

Houston, Texas, United States

Countries

United States

References

Doyle MK, Rahman MU, Frederick B, Birbara CA, de Vries D, Toedter G, Wu X, Chen D, Ranganath VK, Westerman ME, Furst DE. Effects of subcutaneous and intravenous golimumab on inflammatory biomarkers in patients with rheumatoid arthritis: results of a phase 1, randomized, open-label trial. Rheumatology (Oxford). 2013 Jul;52(7):1214-9. doi: 10.1093/rheumatology/kes381. Epub 2013 Feb 14.

Reference Type: DERIVED

PMID: 23418046 (View on PubMed)

Zhuang Y, Xu Z, Frederick B, de Vries DE, Ford JA, Keen M, Doyle MK, Petty KJ, Davis HM, Zhou H. Golimumab pharmacokinetics after repeated subcutaneous and intravenous administrations in patients with rheumatoid arthritis and the effect of concomitant methotrexate: an open-label, randomized study. Clin Ther. 2012 Jan;34(1):77-90. doi: 10.1016/j.clinthera.2011.11.015. Epub 2011 Dec 14.

Reference Type: DERIVED

PMID: 22169051 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=1&filename=CR015550_CSR.pdf

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

Other Identifiers

C0524T14

Identifier Type: OTHER

Identifier Source: secondary_id

CR015550

Identifier Type: -

Identifier Source: org_study_id