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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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