Back to results

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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Golimumab

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Golimumab, Simponi, Rheumatoid Arthritis, PK, PD

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

001

002

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK) (Cmax, AUClast, AUCinf, t1/2, systemic clearance, and volume of distribution) following IV administration

Pharmacokinetics (PK) [Cmax, tmax, AUC (0-4wk), t1/2 for last dose only, R[AUC(0-4wk)] following SC administration

Plasma concentrations of golimumab following IV administration

Plasma concentrations of golimumab following SC administration

Secondary Outcome Measures

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

ACR (American College of Rheumatology) scores

The number and severity of adverse events

Efficacy as assessed by percent change in the American College of Rheumatology (ACR) score

Full Information

NCT ID

NCT01362153

First Posted

March 10, 2011

Last Updated

September 28, 2017

Sponsor

Centocor, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01362153

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

December 26, 2007 (Actual)

Primary Completion Date

February 27, 2009 (Actual)

Study Completion Date

February 27, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centocor, Inc.

4. Oversight

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Golimumab, Simponi, Rheumatoid Arthritis, PK, PD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

001

Arm Type

Experimental

Arm Description

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

Arm Title

002

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Golimumab

Intervention Description

SC injection of 100 mg every 4 weeks through Week 20

Intervention Type

Drug

Intervention Name(s)

Golimumab

Intervention Description

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

Primary Outcome Measure Information:

Title

Pharmacokinetics (PK) (Cmax, AUClast, AUCinf, t1/2, systemic clearance, and volume of distribution) following IV administration

Time Frame

169 days

Title

Pharmacokinetics (PK) [Cmax, tmax, AUC (0-4wk), t1/2 for last dose only, R[AUC(0-4wk)] following SC administration

Time Frame

211 days

Title

Plasma concentrations of golimumab following IV administration

Time Frame

169 days

Title

Plasma concentrations of golimumab following SC administration

Time Frame

211 days

Secondary Outcome Measure Information:

Title

Time Frame

up to 211 days

Title

ACR (American College of Rheumatology) scores

Time Frame

up to 169 days

Title

The number and severity of adverse events

Time Frame

up to 211 days

Title

Efficacy as assessed by percent change in the American College of Rheumatology (ACR) score

Time Frame

up to 169 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Centocor, Inc. Clinical Trial

Organizational Affiliation

Centocor, Inc.

Official's Role

Study Director

Facility Information:

City

Glendale

State/Province

Arizona

Country

United States

City

Aventura

State/Province

Florida

Country

United States

City

Palm Harbor

State/Province

Florida

Country

United States

City

Lexington

State/Province

Kentucky

Country

United States

City

Baton Rouge

State/Province

Louisiana

Country

United States

City

Worcester

State/Province

Massachusetts

Country

United States

City

Oklahoma City

State/Province

Oklahoma

Country

United States

City

Duncansville

State/Province

Pennsylvania

Country

United States

City

Houston

State/Province

Texas

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23418046

Citation

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.

Results Reference

derived

PubMed Identifier

22169051

Citation

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.

Results Reference

derived

Links:

URL

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

Description

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs