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NCT01970475 Clinical Trial

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

Arthritis, Rheumatoid Clinical Trial

— RA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01970475
Other study ID # 20120262
Secondary ID 2013-000525-31
Status Completed
Phase Phase 3
First received October 23, 2013
Last updated May 14, 2015
Start date October 2013
Est. completion date November 2014

Study information
Verified date May 2015
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 study is to compare the effectiveness and safety of ABP 501 against Adalimumab (Humira®) in adult subjects with moderate to severe rheumatoid arthritis (RA) who have an inadequate response to methotrexate (MTX).

Recruitment information / eligibility
Status Completed
Enrollment 526
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Men or women = 18 and = 80 years old

2. Subjects must be diagnosed with Rheumatoid Arthritis for at least 3 months before baseline

3. Active RA defined as = 6 swollen joints and = 6 tender joints at screening and baseline

4. Subjects must be taking MTX for = 12 consecutive weeks and on a stable dose of 7.5 to 25 mg/week for > 8 weeks prior to receiving the study drug and be willing to remain on stable dose throughout the study

5. Subject has no known history of active tuberculosis

Exclusion Criteria:

1. Class IV RA, Felty's syndrome or history of prosthetic or native joint infection

2. Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome

3. Prior use of 2 or more biologic therapies for RA

4. Previous receipt of Humira® (adalimumab) or a biosimilar of adalimumab

5. Ongoing use of prohibited treatments

Other Inclusion/Exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ABP 501

• Adalimumab (Humira®)

Locations
Country Name City State
Bulgaria Research Site Plovdiv
Bulgaria Research Site Plovdiv
Bulgaria Research Site Ruse
Bulgaria Research Site Sofia Sofiya
Bulgaria Research Site Soifia Sofiya
Canada Research Site Montreal Quebec
Canada Research Site St. John's Newfoundland and Labrador
Canada Research Site Windsor Ontario
Canada Research Site Winnipeg Manitoba
Canada Research Site Winnipeg Manitoba
Czech Republic Research Site Hlucín Severomoravsky Kraj
Czech Republic Research Site Hostivice Stredocesky 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 Berlin
Germany Research Site Göttingen Niedersachsen
Germany Research Site Hamburg
Germany Research Site Hattingen Nordrhein-westfalen
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 Székesfehérvár Fejer
Hungary Research Site Szentes Csongrad
Hungary Research Site Veszprém Veszprem
Mexico Research Site Leon Guanajuato
Mexico Research Site Toluca
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
Romania Research Site Bucuresti
Romania Research Site Iasi
Romania Research Site Targoviste Dimbovita
Russian Federation Research Site Petrozavodsk
Russian Federation Research Site Yaroslavl
Spain Research Site Barakaldo Vizcaya
Spain Research Site La Coruña La Coruna
Spain Research Site Madrid
Spain Research Site Mérida Badajoz
Spain Research Site Santiago de Compostela A Coruna
Spain Research Site Sevilla
United Kingdom Research Site Barnsley England
United Kingdom Research Site Cardiff Wales
United Kingdom Research Site Doncaster England
United Kingdom Research Site North Shields England
United Kingdom Research Site Suffolk England
United Kingdom Research Site Suffolk England
United States Research Site Albany New York
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 Dallas Texas
United States Research Site Danbury Connecticut
United States Research Site Duncansville Pennsylvania
United States Research Site Eagan Minnesota
United States Research Site El Cajon California
United States Research Site Fort Lauderdale Florida
United States Research Site Frederick Maryland
United States Research Site Hagerstown Maryland
United States Research Site Hemet California
United States Research Site Huntsville Alabama
United States Research Site Jupiter Florida
United States Research Site Lansing Michigan
United States Research Site Lebanon New Hampshire
United States Research Site Lexington Kentucky
United States Research Site Memphis Tennessee
United States Research Site Miami Florida
United States Research Site Middleburg Heights Ohio
United States Research Site Mineola New York
United States Research Site Oklahoma City Oklahoma
United States Research Site Omaha Nebraska
United States Research Site Orange Park Florida
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 Scottsdale Arizona
United States Research Site Spokane Washington
United States Research Site Tustin California
United States Research Site Van Nuys California
United States Research Site Venice Florida
United States Research Site Victorville California
United States Research Site Voorhees New Jersey
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,  Mexico,  Poland,  Romania,  Russian Federation,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary efficacy endpoint is ACR20 (20% improvement in ACR core set measurements) at week 24. 20% improvement in ACR (American College of Rheumatology) core set measurements Week 24 No
Secondary Disease Activity Score 28-CRP Week 24 No
Secondary ACR50 and ACR70 response 50% or 70% improvement in ACR core set measurements Week 24 No
Secondary Incidence of anti-drug antibodies Week 26 Yes
Secondary Subject incidence of adverse events and serious adverse events Week 26 Yes
Secondary Clinically significant changes in laboratory values and vital signs Week 26 Yes
Secondary ACR20 response 20% improvement in ACR core set measurements Weeks 2 and 8 No
See also
  Status Clinical Trial Phase
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Completed NCT00539760 - A Phase I Rheumatoid Arthritis Study in Healthy Volunteers Phase 1
Active, not recruiting NCT03312465 - Anatomical Shoulder Domelock System Study
Completed NCT01208181 - A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107) Phase 3
Completed NCT03254810 - Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects Phase 1
Completed NCT01711814 - A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study Phase 2
Completed NCT03315494 - Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SKI-O-703 in Healthy Volunteers Phase 1
Withdrawn NCT03241446 - Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA) Phase 1
Completed NCT02553018 - Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe Phase 3
Completed NCT02748785 - MTX Discontinuation and Vaccine Response Phase 4
Active, not recruiting NCT02260778 - Treat-to-target in RA: Collaboration To Improve adOption and adhereNce N/A
Completed NCT02569736 - Characterization of the Effect of Tocilizumab in Vivo and in Vitro on T Follicular Helper Cells in Rheumatoid Arthritis Patients and Consequence on B Cells Maturation
Completed NCT01750931 - This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets. Phase 2
Withdrawn NCT01204138 - Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA Phase 2
Not yet recruiting NCT01154647 - Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes N/A
Completed NCT00975130 - Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2) Phase 3
Completed NCT00973479 - An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy Phase 3
Completed NCT00913458 - Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis Phase 4
Completed NCT00550446 - A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis Phase 2
Completed NCT00660647 - Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA) Phase 3

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