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NCT02114931 Clinical Trial

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

Arthritis, Rheumatoid Clinical Trial

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02114931
Other study ID # 20130258
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received April 11, 2014
Last updated February 3, 2016
Start date April 2014
Est. completion date April 2016

Study information
Verified date February 2016
Source Amgen
Contact n/a
Is FDA regulated No
Health authority Argentina: Ministry of HealthArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBulgaria: Ministry of HealthCanada: Ethics Review CommitteeCanada: Health CanadaCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlGermany: Ethics CommissionGermany: Paul-Ehrlich-InstitutHungary: Institutional Ethics CommitteeHungary: National Institute of PharmacyMexico: Ethics CommitteeMexico: Ministry of HealthPoland: Ethics CommitteePoland: Ministry of HealthRomania: Ethics CommitteeRomania: National Medicines AgencyRussia: Ethics CommitteeRussia: Pharmacological Committee, Ministry of HealthSpain: Agencia Española de Medicamentos y Productos SanitariosSpain: Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this open-label study is to evaluate the long-term safety and efficacy of ABP 501.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 467
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 81 Years
Eligibility Inclusion Criteria:

- Subject was randomized into protocol 20120262 and has 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 has 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ABP 501
ABP 501 (Open Label)

Locations
Country Name City State
Bulgaria Research Site Plovdiv
Bulgaria Research Site Plovdiv
Bulgaria Research Site Ruse
Bulgaria Research Site Soifia Sofiya
Canada Research Site St. John's Newfoundland and Labrador
Canada Research Site Windsor Ontario
Canada Research Site Winnipeg Manitoba
Czech Republic Research Site Hlucín Severomoravsky Kraj
Czech Republic Research Site Ostrava Severomoravsky Kraj
Czech Republic Research Site Praha
Czech Republic Research Site Praha 2 Praha
Czech Republic Research Site Praha 4 Praha
Czech Republic Research Site Praha 4
Czech Republic Research Site Zlín Severomoravsky Kraj
Germany Research Site Göttingen Niedersachsen
Germany Research Site Hamburg
Germany Research Site Leipzig Sachsen
Germany Research Site Ratingen Nordrhein-westfalen
Hungary Research Site Balatonfüred Veszprem
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Szentes Csongrad
Hungary Research Site Veszprém Veszprem
Poland Research Site Bialystok Podlaskie
Poland Research Site Bialystok Podlaskie
Poland Research Site Bydgoszcz Kujawsko-pomorskie
Poland Research Site Dzialdowo Warminsko-mazurskie
Poland Research Site Elblag Warminsko-mazurskie
Poland Research Site Gdansk Pomorskie
Poland Research Site Gdynia Pomorskie
Poland Research Site Koscian Wielkopolskie
Poland Research Site Lublin Lubelskie
Poland Research Site Lublin Lubelskie
Poland Research Site Poznan Wielkopolskie
Poland Research Site Poznan Wielkopolskie
Poland Research Site Torun Kujawsko-pomorskie
Poland Research Site Warszawa Mazowieckie
Poland Research Site Warszawa Mazowieckie
Poland Research Site Wroclaw Dolnoslaskie
Poland Research Site Wroclaw Dolnoslaskie
Romania Research Site Braila
Russian Federation Research Site Petrozavodsk
Spain Research Site La Coruña La Coruna
Spain Research Site Madrid
Spain Research Site Santiago de Compostela A Coruna
Spain Research Site Sevilla
United Kingdom Research Site Suffolk England
United States Research Site Bethlehem Pennsylvania
United States Research Site Brooklyn New York
United States Research Site Carrollton Texas
United States Research Site Charleston South Carolina
United States Research Site Covina California
United States Research Site Dallas Texas
United States Research Site Danbury Connecticut
United States Research Site Duncansville Pennsylvania
United States Research Site El Cajon California
United States Research Site Hagerstown Maryland
United States Research Site Hemet California
United States Research Site Huntsville Alabama
United States Research Site Lexington Kentucky
United States Research Site Memphis Tennessee
United States Research Site Miami Florida
United States Research Site Mineola New York
United States Research Site Oklahoma City Oklahoma
United States Research Site Omaha Nebraska
United States Research Site Orlando Florida
United States Research Site Palm Desert California
United States Research Site Peoria Arizona
United States Research Site Reno Nevada
United States Research Site Saint Louis Missouri
United States Research Site Sandy Springs Georgia
United States Research Site Sarasota Florida
United States Research Site Scottsdale Arizona
United States Research Site Spokane Washington
United States Research Site Van Nuys California
United States Research Site Wheaton Maryland
United States Research Site Whittier California

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czech Republic,  Germany,  Hungary,  Poland,  Romania,  Russian Federation,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Subject incidence of adverse events and serious adverse events Up to week 72 Yes
Primary Clinically significant changes in laboratory values and vital signs Up to week 72 Yes
Primary Incidence of anti-drug antibodies Up to week 72 Yes
Secondary ACR 20 (20% improvement in American College of Rheumatology (ACR) core set measurements at all measured time points) Up to week 70 No
Secondary Disease Activity Score (DAS) 28-CRP at all timepoints Up to week 70 No
See also
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Completed NCT00975130 - Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2) Phase 3
Completed NCT00913458 - Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis Phase 4
Completed NCT00973479 - An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy Phase 3
Completed NCT00550446 - A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis Phase 2
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