Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Commercial Formulation Etanercept · 1 trial · 1 indication
Injection site pain was assessed using a 100 mm visual analog scale (VAS), from 0 mm (No Pain At All) to 100 mm (Worst Pain Imaginable). Participants were asked to indicate the severity of their pain at the injection site by placing a vertical line on the scale.
| Arm | Type | Description |
|---|---|---|
| Sequence AB | EXPERIMENTAL | Participants received a single 50 mg subcutaneous (SC) dose of the commercial formulation etanercept in a prefilled SureClick autoinjector on day 1 (Treatment A) followed by a single 50 mg SC dose of the new formulation of etanercept in a prefilled SureClick autoinjector on day 8 (Treatment B). |
| Sequence BA | EXPERIMENTAL | Participants received a single 50 mg SC dose of the new formulation of etanercept in a prefilled SureClick autoinjector on day 1 (Treatment B) followed by a single 50 mg SC dose of the commercial formulation etanercept in a prefilled SureClick autoinjector on day 8 (Treatment A). |
| Name | Type | Description |
|---|---|---|
| Commercial Formulation Etanercept | DRUG | Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the commercial formulation. |
| New Formulation Etanercept | DRUG | Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the new formulation. |
Inclusion Criteria * Subject has provided informed consent prior to initiation of any study specific activities/procedures. * Male or female subject is 18 years of age or older at time of signing the informed consent form. * Subject has a diagnosis of RA or PsA and indicated for treatment with etan...
Commercial Formulation Etanercept is used for rheumatoid arthritis and psoriatic arthritis. It is being studied in adults with these conditions to assess injection site pain associated with a new etanercept formulation. The drug is currently in Phase 3 clinical development.
Commercial Formulation Etanercept is developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen is conducting clinical trials to evaluate this formulation in patients with rheumatoid arthritis and psoriatic arthritis.
Commercial Formulation Etanercept is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed to evaluate its effects in adults with rheumatoid arthritis or psoriatic arthritis.
Commercial Formulation Etanercept has one completed Phase 3 trial, NCT02986139, titled 'Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis.' The trial enrolled 111 participants in the United States and Puerto Rico.
Yes, Commercial Formulation Etanercept is classified as a small molecule. It is being studied in the therapeutic area of immunology for the treatment of rheumatoid arthritis and psoriatic arthritis.