An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Centocor, Inc.
Study ID
NCT00973479
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Golimumab — DRUG
    Participants will receive 2 mg/kg of golimumab intravenously over 30 ± 10 minutes. Group 1: at Weeks 0, 4, and every 8 weeks thereafter (up to Week 100). Group II: Weeks 24, 28, and every 8 weeks thereafter (up to Week 100); Early escape: at Week 16, 20 and every 8 weeks thereafter (up to Week 100).
  • Placebo — OTHER
    Participants will receive placebo intravenous infusion over 30 ± 10 minutes as: Group I: at Week 16 and 24; Group II: at Weeks 0, 4, 12, 16, and 20; and for early escape: at Week 24.
  • methotrexate (MTX) — DRUG
    Participants will be maintained on their stable dose of commercial MTX (between 15 to 25 mg/week) throughout the study.

Study Details

The purpose of this study is to evaluate clinical effectiveness and safety of golimumab with methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) when compared to MTX alone.

Key Dates

Start date
Sep 30, 2009
Status verified
Nov 2013
Primary completion
Mar 31, 2011
Completion
Feb 28, 2013

Study Design

Enrollment
592 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group I: Placebo + Methotrexate (MTX)
    Participants will receive placebo at Weeks 0, 4, 12, and 16. Participants will cross over to golimumab at Week 24, and receive administrations at Weeks 24, 28, and every 8 weeks thereafter. They will be maintained on their stable dose of commercial methotrexate throughout the study. Participants will be eligible for early escape (receive golimumab) at Week 16 if they demonstrate a less than 10 percent improvement in both tender and swollen joint count. These participants will receive golimumab at Weeks 16, 20, and every 8 weeks thereafter.
  • Placebo Comparator: Group II: Golimumab + Methotrexate (MTX)
    Participants will receive golimumab at Weeks 0, 4, and every 8 weeks thereafter. They will be maintained on their stable dose of commercial methotrexate throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.

Primary Outcome Measure

Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 [ Time Frame: Week 14 ]

Locations (9)

FacilityCityStateZIPSite coordinators
-Daytona BeachFlorida--
-MiamiFlorida--
-Palm HarborFlorida--
-MolineIllinois--
-WheatonMaryland--
-WorcesterMassachusetts--
-LincolnNebraska--
-CincinnatiOhio--
-LubbockTexas--

Find similar trials in Daytona Beach, FL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders

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