Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis

ClinicalTrials.gov ID: NCT01970475

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Official title

A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT01970475
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Amgen; Industry
Enrollment: 526 participants

Conditions and interventions

Conditions

Arthritis, Rheumatoid

Interventions

ABP 501 Biological
Adalimumab Biological

Biological

Eligibility (public fields only)

Age range: 18 Years to 80 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 2013 (Type not available)
Primary completion: Nov 2014 (Actual)
Completion: Nov 2014 (Actual)
Last update posted: Dec 13, 2016

2013 – 2014

United States locations

U.S. sites: 5
U.S. states: 5
U.S. cities: 5

Facility	City	State	ZIP	Site status
Research Site	Victorville	California	92395	—
Research Site	Jupiter	Florida	33458	—
Research Site	Sandy Springs	Georgia	30328	—
Research Site	Lansing	Michigan	48910	—
Research Site	Middleburg Heights	Ohio	44130	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01970475, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 13, 2016 · Synced Nov 12, 2026