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

Part of paid clinical trials in Glendale, Arizona.

Sponsor
Centocor, Inc.
Study ID
NCT01362153
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Golimumab — DRUG
    SC injection of 100 mg every 4 weeks through Week 20
  • Golimumab — DRUG
    IV infusions of 2 mg/kg golimumab on Days 1 and 85.

Study Details

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

Key Dates

Start date
Dec 26, 2007
Status verified
Sep 2017
Primary completion
Feb 27, 2009
Completion
Feb 27, 2009

Study Design

Enrollment
49 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 001
    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

Primary Outcome Measure

Pharmacokinetics (PK) (Cmax, AUClast, AUCinf, t1/2, systemic clearance, and volume of distribution) following IV administration [ Time Frame: 169 days ]

Locations (9)

FacilityCityStateZIPSite coordinators
-GlendaleArizona--
-AventuraFlorida--
-Palm HarborFlorida--
-LexingtonKentucky--
-Baton RougeLouisiana--
-WorcesterMassachusetts--
-Oklahoma CityOklahoma--
-DuncansvillePennsylvania--
-HoustonTexas--

Find similar trials in Glendale, AZ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders

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