NCT00264550

An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Subjects With ActiveRheumatoid Arthritis Despite Methotrexate Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 444 (actual)
• Sponsor: Centocor, 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 golimumab, alone or in combination with methotrexate (MTX), as compared to methotrexate alone in rheumatoid arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX.

Detailed description

This is a randomized (treatment is assigned by chance), double-blind (neither the physician nor the patient is aware of the received treatment), placebo-controlled study of multiple subcutaneous (SC) administrations of golimumab at 2 doses as monotherapy or in combination with MTX in patients with active RA despite treatment with MTX. The duration of participation in the study for an individual patient will be upto 268 weeks. The patients will be randomly assigned in a 3:3:2:2 ratio to receive golimumab 50 mg or 100 mg or placebo injections under the skin every 4 weeks through week 20 and methotrexate or placebo capsules will be given in addition. At Week 24, all subjects will receive golimumab 50mg or 100mg injections, and golimumab continues for all groups for about 4 and a half more years. At Week 16 any patient in the study who meets criteria for \< 20% improvement from baseline in both swollen and tender joint count will enter early escape in a double-blinded fashion. Treatment during the long-term extension will start at Week 52 and continue every 4 weeks thereafter for a total of approximately 5 years from the initial (Week 0) administration of study agent. Patients will return for scheduled follow-up visits generally every 12 weeks for a total length of follow-up of approximately 5 years from the first administration of the study drug.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Golimumab 100 mg	Participants will receive subcutaneous (SC) injections of golimumab 100 mg every 4 weeks.
DRUG	Golimumab 50 mg	Participants will receive subcutaneous (SC) injections of golimumab 50 mg every 4 weeks.
DRUG	Methotrexate	Participants will receive methotrexate capsules weekly.
DRUG	Placebo injection	Participants will receive subcutaneous (SC) injections of placebo every 4 weeks.
DRUG	Placebo capsules	Participants will receive placebo capsules weekly

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-09-01
• Completion: 2012-05-01
• First posted: 2005-12-13
• Last updated: 2014-04-29
• Results posted: 2014-03-21

Locations

50 sites across 12 countries: United States, Argentina, Australia, Canada, Chile, Germany, Hungary, Mexico, New Zealand, Poland, South Korea, Taiwan