Trials / Completed
CompletedNCT01970475
Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 526 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the effectiveness and safety of ABP 501 against adalimumab (HUMIRA®) in adults with moderate to severe rheumatoid arthritis (RA) who have an inadequate response to methotrexate (MTX).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ABP 501 | Solution for subcutaneous injection in pre-filled syringe |
| BIOLOGICAL | Adalimumab | Solution for subcutaneous injection in pre-filled syringe |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2014-11-01
- Completion
- 2014-11-01
- First posted
- 2013-10-28
- Last updated
- 2016-12-13
- Results posted
- 2016-12-13
Locations
11 sites across 4 countries: United States, Canada, Germany, United Kingdom
Source: ClinicalTrials.gov record NCT01970475. Inclusion in this directory is not an endorsement.