Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)

Conditions

• Arthritis
• Arthritis, Rheumatoid
• Autoimmune Diseases

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Golimumab 50 mg SC — DRUG
  Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks.
• Golimumab 2 mg/kg IV — DRUG
  Golimumab 2 milligram per kilogram (mg/kg) intravenous infusion every 8 weeks.
• Methotrexate (MTX) — DRUG
  Participants will continue taking their current Methotrexate (MTX) treatment regimen.
• Placebo SC — DRUG
  Placebo matched to golimumab SC injection every 4 weeks.
• Placebo IV — DRUG
  Placebo matched to golimumab intravenous infusion every 8 weeks.

Study Details

The purpose of this study is to evaluate the efficacy and safety of switching rheumatoid arthritis (RA) participants who have an inadequate response to their current treatment with either etanercept + methotrexate or adalimumab + methotrexate to treatment with golimumab 50 milligram (mg) subcutaneous (SC) injection (a needle inserted under the skin in the back of upper arm, upper thigh or stomach area) every 4 weeks + methotrexate. This study is also designed to evaluate the benefit and safety of switching participants from treatment with golimumab 50 mg subcutaneous injection every 4 weeks + methotrexate to golimumab 2 milligram per kilogram (mg/kg) intravenous every 8 weeks + methotrexate, for those who do not achieve a marked improvement of their RA at Week 16.

Key Dates

Start date

Dec 31, 2009

Status verified

Apr 2015

Primary completion

Jul 31, 2013

Completion

Oct 31, 2013

Study Design

Enrollment

433 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX
  All enrolled and dosed participants receive golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 0 to Week 12.
• Experimental: Double blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX
  Participants, who do not achieve Disease Activity Score in 28 joints (DAS28) good response at Week 16, will be randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
• Experimental: DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX
  Participants, who do not achieve DAS28 good response at Week 16, will be randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
• Experimental: OL Group 1: Golimumab 50 mg SC + MTX
  Participants, who achieve DAS28 good response at Week 16, will receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48.
• Experimental: OL Study Extension Group: Golimumab 50 mg SC + MTX
  Participants who complete the main study (Week 0 to Week 52), do not meet lack of efficacy criteria, and participate in the OL study extension, will receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.

Primary Outcome Measure

Percentage of Participants Achieving Erythrocyte Sedimentation Rate (ESR)-Based American College of Rheumatology [ACR] 20 Response at Week 14 [ Time Frame: Week 14 ]

Locations (89)

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