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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02986139 | Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis | PHASE3 | COMPLETED | 111 | — | — | Nov 29, 2016 | Oct 9, 2017 | Jul 18, 2019 | 30 | United States, Puerto Rico |
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...