At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating SC golimumab and IV golimumab for Arthritis, Rheumatoid. Completed, enrolled 3,366 participants.
Detailed 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.
Study Details
Timeline
Interventions
Subcutaneous golimumab at a dose of 50 mg administered once monthly.
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.