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Also known as etanercept pre-filled syringe subcutaneous injection
etanercept pre-filled syringe · 1 trial · 1 indication
The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3.
| Arm | Type | Description |
|---|---|---|
| Open Label Run-In: Etanercept plus Methotrexate | EXPERIMENTAL | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 24 weeks. Participants also receive folic acid as standard of care. |
| Double-Blind Treatment: Methotrexate Monotherapy | EXPERIMENTAL | Oral methotrexate 10 to 25 mg weekly plus placebo for etanercept for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening will initiate rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg). |
| Double-Blind Treatment: Etanercept Monotherapy | EXPERIMENTAL | Etanercept 50 mg weekly by subcutaneous injection plus placebo for methotrexate for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening will initiate rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg). |
| Double-Blind Treatment: Etanercept plus Methotrexate | EXPERIMENTAL | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening will continue on the assigned treatments (as rescue treatment). |
| Name | Type | Description |
|---|---|---|
| etanercept pre-filled syringe subcutaneous injection | DRUG | etanercept for injection in pre-filled syringes |
| Oral methotrexate | DRUG | During the open-label run-in period, methotrexate will be provided as 2.5 mg tablets. During the double-blind treatment period, methotrexate will be provided as 2.5 mg capsules. |
| Placebo for etanercept subcutaneous injection | DRUG | etanercept placebo for injection in pre-filled syringes |
| Placebo for methotrexate | DRUG | methotrexate placebo capsules |
| Folic acid (non-investigational product) | DIETARY_SUPPLEMENT | Folic acid 5 to 7 mg per week as per investigator judgment or according to local standard of care. |
Inclusion Criteria (Part 1, Run-In Period): * Subjects must be adults with a history of moderate to severe rheumatoid arthritis; * Subjects must be in very good rheumatoid arthritis disease control for ≥ 6 months and be in remission as defined by a Simplified Disease Activity Index ≤ 3.3 at screeni...
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Etanercept pre-filled syringe is a subcutaneous injection form of etanercept, a TNF inhibitor developed by Amgen Inc. (ticker AMGN). It is being studied in Phase 3 clinical development for rheumatoid arthritis, an immunology condition. The pre-filled syringe format delivers the drug by subcutaneous injection.
Etanercept pre-filled syringe is being developed for rheumatoid arthritis, including maintenance of remission. A completed Phase 3 trial, NCT02373813, studied etanercept monotherapy versus methotrexate monotherapy for maintaining rheumatoid arthritis remission in 371 enrolled patients across the United States, Europe, Latin America, Canada, and South Africa.
Etanercept pre-filled syringe targets TNF, or tumor necrosis factor, and acts as a TNF inhibitor. By inhibiting TNF, the subcutaneous injection is designed to reduce the inflammatory signaling associated with rheumatoid arthritis. This mechanism places it in the immunology therapeutic area.
Amgen Inc., which trades under the ticker AMGN, is the developer of etanercept pre-filled syringe. The company is responsible for the subcutaneous injection form of etanercept studied in rheumatoid arthritis.
Etanercept pre-filled syringe is in Phase 3 clinical development for rheumatoid arthritis. It is investigational and has not been approved by the FDA. The Phase 3 program includes one completed trial, and no active trials are currently listed.
Etanercept pre-filled syringe has been evaluated in the Phase 3 trial NCT02373813, titled Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission. The trial was completed, enrolled 371 patients, was randomized, double-blind, and controlled, and included participants aged 18 years and older.
Yes. Etanercept pre-filled syringe is also known as etanercept pre-filled syringe subcutaneous injection. Both names refer to the same Amgen Inc. (AMGN) product candidate, a TNF inhibitor administered by subcutaneous injection and studied in Phase 3 for rheumatoid arthritis.