CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 311 enrolled
Drug / intervention
ABP 798 +2 moredrug
Likely dose
ABP 798 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02792699
NCT02792699Phase 3Completed

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

Amgen·interventional·Posted Jun 7, 2016·Updated Oct 6, 2020

In Brief

A Phase 3 clinical trial evaluating ABP 798, Rituximab (US), and 1 other intervention for Arthritis, Rheumatoid. Completed, enrolled 311 participants across 55 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Estonia, Germany, Hungary, Poland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 7, 2016
Enrollment StartMay 17, 2016
Primary CompletionOct 8, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.1 years ago

Interventions

ABP 798drug

Supplied as a 10 mg/mL liquid concentrate for intravenous (IV) administration.

Rituximab (US)drug

Supplied as a 10 mg/mL liquid concentrate for IV administration.

Rituximab (EU)drug

Supplied as a 10 mg/mL liquid concentrate for IV administration.