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Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab

NCT02792699 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2020-10-06

Study results available
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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

  • Arthritis, Rheumatoid

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-17
Primary Completion
2018-10-08
Completion
2018-10-08

Countries

  • United States
  • Bulgaria
  • Estonia
  • Germany
  • Hungary
  • Poland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02792699 on ClinicalTrials.gov