Trials / Completed
CompletedNCT02378506
Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects
A Single-arm, Open-label Study To Assess The Immunogenicity, Safety, And Efficacy Of Etanercept Manufactured Using The High Capacity Process Administered To Subjects With Rheumatoid Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 188 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the high capacity process. Descriptive results will be provided however a formal hypothesis will not be tested in this trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | etanercept | 50mg subcutaneous, once weekly, 24 weeks |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2016-05-01
- Completion
- 2016-06-01
- First posted
- 2015-03-04
- Last updated
- 2017-05-15
- Results posted
- 2017-05-15
Locations
31 sites across 9 countries: Bulgaria, Croatia, Germany, Greece, Hungary, Poland, Serbia, Slovakia, South Africa
Source: ClinicalTrials.gov record NCT02378506. Inclusion in this directory is not an endorsement.