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
18 Years
N/A
Both
Rheumatoid Arthritis
Trial Information
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
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.
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pharmacokinetics (PK) (Cmax, AUClast, AUCinf, t1/2, systemic clearance, and volume of distribution) following IV administration
Outcome Time Frame:
169 days
Safety Issue:
No
Principal Investigator
Centocor, Inc. Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Centocor, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
CR015550
NCT ID:
NCT01362153
Start Date:
December 2007
Completion Date:
February 2009
Related Keywords:
- Rheumatoid Arthritis
- Golimumab
- Simponi
- Rheumatoid Arthritis
- PK
- PD
- Arthritis
- Arthritis, Rheumatoid
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