A Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Golimumab in Patients With Rheumatoid Arthritis (RA)
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
2 other identifiers
interventional
49
1 country
9
Brief Summary
This is a Phase 1, pharmacokinetic and pharmacodynamic study of intravenous and subcutaneous administered golimumab in patients with rheumatoid arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 rheumatoid-arthritis
Started Dec 2007
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2009
CompletedFirst Submitted
Initial submission to the registry
March 10, 2011
CompletedFirst Posted
Study publicly available on registry
May 30, 2011
CompletedOctober 2, 2017
September 1, 2017
1.2 years
March 10, 2011
September 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Pharmacokinetics (PK) (Cmax, AUClast, AUCinf, t1/2, systemic clearance, and volume of distribution) following IV administration
169 days
Pharmacokinetics (PK) [Cmax, tmax, AUC (0-4wk), t1/2 for last dose only, R[AUC(0-4wk)] following SC administration
211 days
Plasma concentrations of golimumab following IV administration
169 days
Plasma concentrations of golimumab following SC administration
211 days
Secondary Outcomes (4)
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
ACR (American College of Rheumatology) scores
up to 169 days
The number and severity of adverse events
up to 211 days
Efficacy as assessed by percent change in the American College of Rheumatology (ACR) score
up to 169 days
Study Arms (2)
001
EXPERIMENTALGolimumab IV infusions of 2 mg/kg golimumab on Days 1 and 85.
002
EXPERIMENTALGolimumab SC injection of 100 mg every 4 weeks through Week 20
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
Study Sites (9)
Unknown Facility
Glendale, Arizona, United States
Unknown Facility
Aventura, Florida, United States
Unknown Facility
Palm Harbor, Florida, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Baton Rouge, Louisiana, United States
Unknown Facility
Worcester, Massachusetts, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Duncansville, Pennsylvania, United States
Unknown Facility
Houston, Texas, United States
Related Publications (2)
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.
PMID: 23418046DERIVEDZhuang 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.
PMID: 22169051DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2011
First Posted
May 30, 2011
Study Start
December 26, 2007
Primary Completion
February 27, 2009
Study Completion
February 27, 2009
Last Updated
October 2, 2017
Record last verified: 2017-09