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Trial record 87 of 1254 for:    arthritis+management

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

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ClinicalTrials.gov Identifier: NCT01362153
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Golimumab Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 26, 2007
Actual Primary Completion Date : February 27, 2009
Actual Study Completion Date : February 27, 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Golimumab

Arm Intervention/treatment
Experimental: 001
Golimumab IV infusions of 2 mg/kg golimumab on Days 1 and 85.
Drug: Golimumab
IV infusions of 2 mg/kg golimumab on Days 1 and 85.

Experimental: 002
Golimumab SC injection of 100 mg every 4 weeks through Week 20
Drug: Golimumab
SC injection of 100 mg every 4 weeks through Week 20




Primary Outcome Measures :
  1. Pharmacokinetics (PK) (Cmax, AUClast, AUCinf, t1/2, systemic clearance, and volume of distribution) following IV administration [ Time Frame: 169 days ]
  2. Pharmacokinetics (PK) [Cmax, tmax, AUC (0-4wk), t1/2 for last dose only, R[AUC(0-4wk)] following SC administration [ Time Frame: 211 days ]
  3. Plasma concentrations of golimumab following IV administration [ Time Frame: 169 days ]
  4. Plasma concentrations of golimumab following SC administration [ Time Frame: 211 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. ACR (American College of Rheumatology) scores [ Time Frame: up to 169 days ]
  3. The number and severity of adverse events [ Time Frame: up to 211 days ]
  4. Efficacy as assessed by percent change in the American College of Rheumatology (ACR) score [ Time Frame: up to 169 days ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362153


Locations
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United States, Arizona
Glendale, Arizona, United States
United States, Florida
Aventura, Florida, United States
Palm Harbor, Florida, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Louisiana
Baton Rouge, Louisiana, United States
United States, Massachusetts
Worcester, Massachusetts, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Centocor, Inc.
Investigators
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Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT01362153     History of Changes
Other Study ID Numbers: CR015550
C0524T14 ( Other Identifier: Centocor )
First Posted: May 30, 2011    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centocor, Inc.:
Golimumab
Simponi
Rheumatoid Arthritis
PK
PD
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs