Trials / Completed
CompletedNCT02792699
Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab
A Randomized, Double-blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 311 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe RA. This study will also assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABP 798 | Supplied as a 10 mg/mL liquid concentrate for intravenous (IV) administration. |
| DRUG | Rituximab (US) | Supplied as a 10 mg/mL liquid concentrate for IV administration. |
| DRUG | Rituximab (EU) | Supplied as a 10 mg/mL liquid concentrate for IV administration. |
Timeline
- Start date
- 2016-05-17
- Primary completion
- 2018-10-08
- Completion
- 2018-10-08
- First posted
- 2016-06-07
- Last updated
- 2020-10-06
- Results posted
- 2019-10-23
Locations
55 sites across 6 countries: United States, Bulgaria, Estonia, Germany, Hungary, Poland
Source: ClinicalTrials.gov record NCT02792699. Inclusion in this directory is not an endorsement.