CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 526 enrolled
Drug / intervention
ABP 501 +1 morebiological
Likely dose
Not stated in 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/NCT01970475
NCT01970475Phase 3Completed

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

Amgen·interventional·Posted Oct 28, 2013·Updated Dec 13, 2016

In Brief

A Phase 3 clinical trial evaluating ABP 501 and Adalimumab for Arthritis, Rheumatoid. Completed, enrolled 526 participants across 11 sites in 4 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Germany, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 28, 2013
Enrollment StartOct 1, 2013
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.7 years ago

Interventions

ABP 501biological

Solution for subcutaneous injection in pre-filled syringe

Adalimumabbiological

Solution for subcutaneous injection in pre-filled syringe