Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00975130 | Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2) | PHASE3 | COMPLETED | 3,366 | — | — | Sep 1, 2009 | Feb 1, 2012 | Apr 13, 2017 | - | — |
EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease \>1.2 units and a final DAS28-ESR \< 3.2 units, while a moderate response was defined as a decrease \> 1.2 units and final DAS28-ESR \>= 3.2 units, OR a decrease of 0.6 to 1.2 units AND final DAS28-ESR \<= 5.1 units
The number of participants experiencing DAS28-ESR remission was evaluated at the start of study Month 11 and the end of study Month 12. The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR \<2.6.
| Arm | Type | Description |
|---|---|---|
| SC-GLM50 | EXPERIMENTAL | In Part 1 of the study, participants received subcutaneous golimumab treatment at a dose of 50 mg once monthly for 6 months in combination with background DMARD treatment. |
| IV GLM 2 mg/kg + GLM50-SC | EXPERIMENTAL | After 6 months of treatment in study Part 1, participants with good or moderate response but not in remission will receive intravenous (IV) golimumab at a dose of 2 mg/kg once monthly for a period of 6 months or until remission is achieved. Participants will receive IV GLM at a dose of 2 mg/kg at the start of Month 7, and then at the start of Month 8 and Month 10 if the subject has not achieved remission at any of these IV administration visits. If remission is achieved, participants were switched to subcutaneous golimumab at a dose of 50 mg once monthly until study end, in combination with background DMARD treatment. |
| GLM50-SC | EXPERIMENTAL | After 6 months of treatment in study Part 1, participants with good or moderate response but not in remission will receive subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months, in combination with background DMARD treatment. |
| Name | Type | Description |
|---|---|---|
| SC golimumab | BIOLOGICAL | Subcutaneous golimumab at a dose of 50 mg administered once monthly. |
| IV golimumab | BIOLOGICAL | 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. |
Inclusion Criteria: For Part 1: * Age \>=18 years, either sex, any race. * Diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria. * Active disease despite DMARD treatment * Subject must be taking at least one of the allowed DMARDs, and must be able to contin...