NCT00975130

Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)

An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,366 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Part 1 of this trial will assess the safety and effectiveness of subcutaneous (SC) golimumab administered by autoinjector once monthly, when combined with different disease-modifying antirheumatic drug (DMARD) regimens used in daily rheumatology practice. Subsequently, Part 2 will study if a strategy of intravenous (IV) golimumab to induce remission followed by SC golimumab to retain remission is superior to continuing a SC regimen.

Detailed description

Participants who had a good or moderate European League Against Rheumatism (EULAR) response but not achieve remission at the end of Part 1 were invited to participate in Part 2 and were randomized to either intravenous golimumab (IV GLM) + subcutaneous golimumab (SC GLM) or SC GLM alone.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
BIOLOGICAL	SC golimumab	Subcutaneous golimumab at a dose of 50 mg administered once monthly.
BIOLOGICAL	IV golimumab	Intravenous golimumab administered up to 3 times (month 7, 8, 10) during a period of 6 months at a dose of 2 mg/kg of body weight.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-08-01
• Completion: 2012-02-01
• First posted: 2009-09-11
• Last updated: 2017-04-13
• Results posted: 2012-12-07