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

Centocor Ortho Biotech

Status and phase

Completed

Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Drug: Golimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01362153

C0524T14 (Other Identifier)

CR015550

Details and patient eligibility

About

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

Full 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.

Enrollment

49 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No 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)