NCT01004432

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

A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment With Etanercept (ENBREL) or Adalimumab (HUMIRA)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 433 (actual)
• Sponsor: Janssen Biotech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study consists of a main study and a voluntary, open-label (participants and researchers are aware about the treatment participants are receiving), 24-week study extension. The main study includes a Screening Run-in Period (Week -6 to Week 0), an Open-label Treatment Period (Week 0 to Week 16), an Open-label or Double-blind Treatment Period (Week 16 to Week 52). The main study also includes a Follow-up Period from Week 52 through Week 64 for those participants who will not participate in the 24-week study extension. Participants, participating in 24-week extension (at Week 52), will receive open-label golimumab SC injections every 4 weeks from Week 52 up to Week 72 and will be followed-up up to Week 88. All eligible participants will initiate the treatment with open-label golimumab SC injection every 4 weeks up to Week 12. At Week 16, depending upon the treatment response either participants will continue to receive open-label golimumab SC injection every 4 weeks up to Week 48 or participants will be randomly assigned to receive following 2 treatments: 1- golimumab 50mg SC injection every 4 weeks along with placebo intravenous infusion every 8 weeks through Week 48; 2- Placebo SC injection every 4 weeks along with golimumab 2mg/kg intravenous infusion every 8 weeks through Week 48. At Week 52, participants who choose to participate in the 24-week study extension will receive open-label golimumab 50 mg SC injections every 4 weeks through Week 72. Participants' safety will be monitored throughout the study.

Conditions

• Arthritis
• Arthritis, Rheumatoid
• Autoimmune Diseases

Interventions

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

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-07-01
• Completion: 2013-10-01
• First posted: 2009-10-30
• Last updated: 2015-04-30
• Results posted: 2014-05-13

Locations

117 sites across 8 countries: United States, Austria, Belgium, Canada, Germany, Greece, Sweden, United Kingdom