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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01004432 | Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA) | PHASE3 | COMPLETED | 433 | — | — | Dec 1, 2009 | Oct 1, 2013 | Apr 30, 2015 | 117 | United States, Austria +6 |
Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (\>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and \>=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters \[cm\]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.
| Arm | Type | Description |
|---|---|---|
| Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX | EXPERIMENTAL | All enrolled and dosed participants receive golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 0 to Week 12. |
| Double blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX | EXPERIMENTAL | Participants, who do not achieve Disease Activity Score in 28 joints (DAS28) good response at Week 16, will be randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44. |
| DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX | EXPERIMENTAL | Participants, who do not achieve DAS28 good response at Week 16, will be randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48. |
| OL Group 1: Golimumab 50 mg SC + MTX | EXPERIMENTAL | Participants, who achieve DAS28 good response at Week 16, will receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48. |
| OL Study Extension Group: Golimumab 50 mg SC + MTX | EXPERIMENTAL | Participants who complete the main study (Week 0 to Week 52), do not meet lack of efficacy criteria, and participate in the OL study extension, will receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72. |
| Name | Type | Description |
|---|---|---|
| Golimumab 50 mg SC | DRUG | Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks. |
| Golimumab 2 mg/kg IV | DRUG | Golimumab 2 milligram per kilogram (mg/kg) intravenous infusion every 8 weeks. |
| Methotrexate (MTX) | DRUG | Participants will continue taking their current Methotrexate (MTX) treatment regimen. |
| Placebo SC | DRUG | Placebo matched to golimumab SC injection every 4 weeks. |
| Placebo IV | DRUG | Placebo matched to golimumab intravenous infusion every 8 weeks. |
Inclusion Criteria: * Have inadequate RA disease control prior to the first administration of study agent despite treatment with etanercept (Enbrel) + methotrexate or adalimumab (Humira) + methotrexate (MTX) * Must have received a stable dose of MTX greater than or equal to (\>=) 7.5 milligram (mg)...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 5 | PHASE4 | Undisclosed |
| Smith & Nephew plc Sponsored ADR | SNN | 3 | PHASE4 | Undisclosed |
| Johnson & Johnson | JNJ | 1 | PHASE4 | Undisclosed |