Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis

March 13, 2017 updated by: Amgen

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis

The purpose of this open-label study is to evaluate the long-term safety and efficacy of ABP 501 in adults with moderate to severe rheumatoid arthritis (RA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

467

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4003
        • Research Site
      • Plovdiv, Bulgaria, 4002
        • Research Site
      • Ruse, Bulgaria, 7012
        • Research Site
    • Sofiya
      • Soifia, Sofiya, Bulgaria, 1612
        • Research Site
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3N 0K6
        • Research Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 5E8
        • Research Site
    • Ontario
      • Windsor, Ontario, Canada, N8X 5A6
        • Research Site
  • Czech Republic
      • Praha, Czech Republic, 140 59
        • Research Site
      • Praha 4, Czech Republic, 140 00
        • Research Site
    • Praha
      • Praha 2, Praha, Czech Republic, 128 50
        • Research Site
      • Praha 4, Praha, Czech Republic, 140 00
        • Research Site
    • Severomoravsky Kraj
      • Hlučín, Severomoravsky Kraj, Czech Republic, 748 01
        • Research Site
      • Ostrava, Severomoravsky Kraj, Czech Republic, 702 00
        • Research Site
      • Zlín, Severomoravsky Kraj, Czech Republic, 760 01
        • Research Site
  • Germany
      • Hamburg, Germany, 22391
        • Research Site
    • Niedersachsen
      • Göttingen, Niedersachsen, Germany, 37075
        • Research Site
    • Nordrhein-westfalen
      • Ratingen, Nordrhein-westfalen, Germany, 40882
        • Research Site
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Research Site
  • Hungary
      • Budapest, Hungary, 1036
        • Research Site
      • Budapest, Hungary, 1027
        • Research Site
      • Budapest, Hungary, 1023
        • Research Site
    • Csongrad
      • Szentes, Csongrad, Hungary, 6600
        • Research Site
    • Veszprem
      • Balatonfüred, Veszprem, Hungary, 8230
        • Research Site
      • Veszprém, Veszprem, Hungary, 8200
        • Research Site
  • Poland
    • Dolnoslaskie
      • Wrocław, Dolnoslaskie, Poland, 50-088
        • Research Site
      • Wrocław, Dolnoslaskie, Poland, 52-416
        • Research Site
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
        • Research Site
      • Toruń, Kujawsko-pomorskie, Poland, 87-100
        • Research Site
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-582
        • Research Site
      • Lublin, Lubelskie, Poland, 20-022
        • Research Site
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 01-192
        • Research Site
      • Warszawa, Mazowieckie, Poland, 01-518
        • Research Site
    • Podlaskie
      • Białystok, Podlaskie, Poland, 15-099
        • Research Site
      • Białystok, Podlaskie, Poland, 15-351
        • Research Site
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-307
        • Research Site
      • Gdynia, Pomorskie, Poland, 81-338
        • Research Site
    • Warminsko-mazurskie
      • Działdowo, Warminsko-mazurskie, Poland, 13-200
        • Research Site
      • Elbląg, Warminsko-mazurskie, Poland, 82-300
        • Research Site
    • Wielkopolskie
      • Kościan, Wielkopolskie, Poland, 64-000
        • Research Site
      • Poznań, Wielkopolskie, Poland, 60-218
        • Research Site
      • Poznań, Wielkopolskie, Poland, 61-113
        • Research Site
  • Romania
      • Braila, Romania, 810019
        • Research Site
  • Russian Federation
      • Petrozavodsk, Russian Federation, 185019
        • Research Site
  • Spain
      • Madrid, Spain, 28041
        • Research Site
      • Sevilla, Spain, 41009
        • Research Site
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15705
        • Research Site
    • La Coruna
      • La Coruña, La Coruna, Spain, 15006
        • Research Site
  • United Kingdom
    • England
      • Suffolk, England, United Kingdom, IP33 2QZ
        • Research Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Research Site
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Research Site
      • Scottsdale, Arizona, United States, 85258
        • Research Site
    • California
      • Covina, California, United States, 91723
        • Research Site
      • El Cajon, California, United States, 92020
        • Research Site
      • Hemet, California, United States, 92543
        • Research Site
      • Palm Desert, California, United States, 92260
        • Research Site
      • Van Nuys, California, United States, 91405
        • Research Site
      • Whittier, California, United States, 90602
        • Research Site
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Research Site
    • Florida
      • Miami, Florida, United States, 33015
        • Research Site
      • Orlando, Florida, United States, 32804
        • Research Site
      • Sarasota, Florida, United States, 34233
        • Research Site
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Research Site
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Research Site
      • Wheaton, Maryland, United States, 20902
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Research Site
    • New York
      • Brooklyn, New York, United States, 11201
        • Research Site
      • Mineola, New York, United States, 11501
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Research Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Research Site
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Research Site
    • Texas
      • Carrollton, Texas, United States, 75007
        • Research Site
      • Dallas, Texas, United States, 75231
        • Research Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject was randomized into protocol 20120262 (NCT01970475) and completed the week 26 visit

Exclusion Criteria:

  • Subject experienced a serious adverse event (SAE) or an adverse event (AE) in the 20120262 study that could cause extension treatment to be detrimental
  • Subject completed study 20120262 but cannot be dosed within 4 weeks of the week 26 visit of study 20120262
  • Current infection requiring the use of oral or intravenous antibiotics

Other Inclusion/Exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABP 501
Participants received ABP 501 40 mg subcutaneously (SC) every other week for up to 18 months.
Biological: ABP 501
Solution for subcutaneous injection in a syringe containing 40 mg/0.8 mL ABP 501
Other Names:
  • Adalimumab-atto
  • AMJEVITA™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks

Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale:

1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal. A treatment-related AE is defined as an event where the answer to the question "is there a reasonable possibility that the event may have been caused by the Investigational Medicinal Product" was yes.

A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria:

  • fatal
  • life threatening (places the subject at immediate risk of death)
  • requires inpatient hospitalization or prolongation of existing hospitalization
  • results in persistent or significant disability/incapacity
  • congenital anomaly/birth defect
  • other medically important serious event.
From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks
Number of Participants With Grade ≥ 3 Hematology and Chemistry Laboratory Results
Time Frame: From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks

Laboratory results were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale:

1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal.
From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks
Percentage of Participants Who Developed Antibodies to ABP 501
Time Frame: Up to week 72

Two validated assays were used to detect the presence of anti-drug antibodies. All samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies against ABP 501 (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.

Preexisting antibody positive indicates participants with a positive result at baseline of the extension study. Developing antibody positive indicates participants with a negative or no result at baseline of the extension study who were positive at any time point post-baseline during the extension study.
Up to week 72

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response
Time Frame: Parent study baseline, extension study baseline and weeks 4, 24, 48, and 70

A participant was a responder if the following 3 criteria for improvement from Baseline of the parent study were met:

  • ≥ 20% improvement in tender joint count;
  • ≥ 20% improvement in swollen joint count; and

  • ≥ 20% improvement in at least 3 of the 5 following parameters:

    • Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
    • Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);
    • Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);
    • Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
    • C-Reactive Protein level.
Parent study baseline, extension study baseline and weeks 4, 24, 48, and 70
Change From Parent Study Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)
Time Frame: Parent study baseline, extension study baseline and weeks 4, 24, 48 and 70

The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:

  • The number of swollen and tender joints assessed using the 28-joint count;
  • C-reactive protein (CRP) level
  • Patient's global assessment of disease activity assessed on a score from 0 to 100 transformed from the result measured on a horizontal scale from 0 (no RA activity at all) to 10 (worst RA activity imaginable).

The DAS28-CRP score ranges from approximately zero to ten. Higher DAS28-CRP scores indicate higher disease activity.
Parent study baseline, extension study baseline and weeks 4, 24, 48 and 70

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: Amgen MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

April 11, 2014

First Submitted That Met QC Criteria

April 11, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Actual)

April 24, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130258
  • 2013-004654-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthritis, Rheumatoid

Clinical Trials on ABP 501

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe