Drug Concentration, Immunogenicity, and Efficacy Study in Patients With Rheumatoid Arthritis Currently Treated With Etanercept, Adalimumab, or Infliximab

NCT ID: NCT01981473

Last Updated: 2016-01-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

605 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to examine the relationship between anti-drug antibodies, serum drug concentrations, and clinical response for rheumatoid arthritis patients being treated with etanercept, adalimumab or infliximab.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

cross-sectional Population will be selected through convenience sampling. Patients sequentially visiting the rheumatology clinic for routine care who are receiving etanercept, adalimumab, or infliximab for between 6 and 24 months will be evaluated for eligibility and interest in participation. A maximum of 200 patients per treatment will be enrolled.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

etanercept

Participants currently receiving etanercept treatment in a clinical setting for a minimum of 6 months and maximum of 24 months prior to study assessment visit.

no intervention

Intervention Type OTHER

adalimumab

Participants currently receiving adalimumab treatment in a clinical setting for a minimum of 6 months and maximum of 24 months prior to study assessment visit.

no intervention

Intervention Type OTHER

infliximab

Participants currently receiving infliximab treatment in a clinical setting for a minimum of 6 months and maximum of 24 months prior to study assessment visit.

no intervention

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

no intervention

Intervention Type OTHER

no intervention

Intervention Type OTHER

no intervention

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Enbrel Humira Remicade

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 18 years or older.
2. Diagnosis of RA based on the 1987 American College of Rheumatology revised criteria
3. Current continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months and maximum of 24 months.

Exclusion Criteria

1. Treatment with biosimilar or investigational etanercept, adalimumab, or infliximab within past 6 months.
2. Treatment with any other investigational drugs within past 3 months or five half lives of the drug, whichever is longer.
3. Any medical condition that would interfere with rheumatoid arthritis evaluation or other study assessments (eg, fibromyalgia, lupus).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arizona Arthritis & Rheumatology

Glendale, Arizona, United States

Site Status

Arizona Arthritis & Rheumatology Associates, P. C.

Mesa, Arizona, United States

Site Status

Arizona Arthritis & Rheumatology

Phoenix, Arizona, United States

Site Status

Arizona Arthritis and Rheumatology Research, PLLC

Phoenix, Arizona, United States

Site Status

Arizona Arthritis & Rheumatology Research

Sun City, Arizona, United States

Site Status

Mercy Clinic Hot Springs Communities

Hot Springs, Arkansas, United States

Site Status

Sutter Institute for Medical Research

Sacramento, California, United States

Site Status

Arthritis Care Center, Incorporated

San Jose, California, United States

Site Status

Rheumatology Consultants of Delaware dba Delaware Arthritis

Lewes, Delaware, United States

Site Status

Omega Research Consultants, LLC

DeBary, Florida, United States

Site Status

Center for Rheumatology, Immunology, and Arthritis

Fort Lauderdale, Florida, United States

Site Status

Florida Medical Research

Gainesville, Florida, United States

Site Status

Arthritis and Rheumatic Care Center

South Miami, Florida, United States

Site Status

Health Point Medical Group, Inc.

Tampa, Florida, United States

Site Status

Northeast Georgia Diagnostic Clinic, LLC

Gainesville, Georgia, United States

Site Status

Via Christi Hospitals Wichita, Inc.

Wichita, Kansas, United States

Site Status

Rheumatology Associates of Baltimore

Baltimore, Maryland, United States

Site Status

Phase III Clinical Research

Fall River, Massachusetts, United States

Site Status

David S. Rosenberg, M.D

Florissant, Missouri, United States

Site Status

Dr Melvin Albert Churchill Jr

Lincoln, Nebraska, United States

Site Status

Prospect Medical Offices

Midland Park, New Jersey, United States

Site Status

Advanced Arthritis Care Center

Brooklyn, New York, United States

Site Status

Prem C.Chatpar, M.D., LLC

Plainview, New York, United States

Site Status

Box Arthritis and Rheumatology

Charlotte, North Carolina, United States

Site Status

Clinical Research Center of Reading, LLC

Wyomissing, Pennsylvania, United States

Site Status

Low Country Rheumatology, PA

North Charleston, South Carolina, United States

Site Status

Comprehensive Rheumatology Care

Hendersonville, Tennessee, United States

Site Status

Elizabeth Marini Simpson

Hixon, Tennessee, United States

Site Status

Austin Regional Clinic

Austin, Texas, United States

Site Status

Accurate Clinical Research

Houston, Texas, United States

Site Status

Clinical Research Institute of Houston

Houston, Texas, United States

Site Status

Spring Clinical Research

Tomball, Texas, United States

Site Status

Center for Arthritis and Rheumatic Diseases, P.C.

Chesapeake, Virginia, United States

Site Status

Arthritis Northwest, PLLC

Spokane, Washington, United States

Site Status

Hospital Británico de Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Sociedad Italiana de Beneficencia en Buenos Aires (Hospital Italiano de Buenos Aires)

Ciudad Autónoma de Buenos Aires / Buenos Aires, Buenos Aires / Argentina, Argentina

Site Status

Instituto de Asistencia Reumatológica Integral I.A.R.I

San Fernando, Buenos Aires / Argentina, Argentina

Site Status

Clínica Adventista Belgrano

Ciudad Autónoma de Buenos Aires / Buenos Aires, Ciudad Autónoma de Buenos Aires / Buenos Aires /Argentina., Argentina

Site Status

CIER, centro de investigaciones en enfermedades reumáticas (Razón social: ARIES MEDICA S.R.L.)

Ciudad de Buenos Aires / Buenos Aires, Ciudad de Buenos Aires, Buenos Aires, Argentina, Argentina

Site Status

Sociedad Española de Beneficiencia y Mutualidad Hospital español de Mendoza

Godoy Cruz, Mendoza / Argentina, Argentina

Site Status

DIM Clinica Privada

Ramos Mejía, Ramos Mejía / Buenos Aires / Argentina, Argentina

Site Status

Centro Integral de Reumatología S.R.L.

S.M. de Tucumán / Tucumán, S.M. de Tucumán / Tucumán / Argentina., Argentina

Site Status

C.E.R - Centro Polivalente de Asistencia e Investigación Clínica propiedad de CER SAN JUAN S.R.L.

San Juan, San Juan / San Juan / Buenos Aires, Argentina

Site Status

Instituto CAICI SRL.

Rosario, Santa Fe / Argentina, Argentina

Site Status

I.N.Ne.L S.R.L. (Instituto de Neurología y Neurorrehabilitación del Litoral S.R.L.)

Santa Fé, Santa Fé / Argentina, Argentina

Site Status

Southern Clinical Research Pty Ltd

Sandy Bay, Hobart, Tasmania, Australia

Site Status

MHAT Burgas

Burgas, , Bulgaria

Site Status

DCC Sveti Pantaleimon OOD

Pleven, , Bulgaria

Site Status

MHAT Kaspela EOOD

Plovdiv, , Bulgaria

Site Status

UMHAT "Sv.Ivan Rilski"

Sofia, , Bulgaria

Site Status

Cukurova Universitesi Tip Fakultesi Balcalı Hastanesi

Adana, , Turkey (Türkiye)

Site Status

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Ataturk Universitesi Yakutiye Egitim ve Arastirma Hastanesi

Erzurum, , Turkey (Türkiye)

Site Status

Osmangazi Universitesi Tıp Fakultesi Hastanesi

Eskişehir, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Bulgaria Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Bassiouni H, Spargo CE, Vlahos B, Jones HE, Pedersen R, Shirazy K. Maintenance of Remission with Etanercept-DMARD Combination Therapy Compared with DMARDs Alone in African and Middle Eastern Patients with Active Rheumatoid Arthritis. Rheumatol Ther. 2018 Jun;5(1):149-158. doi: 10.1007/s40744-018-0094-6. Epub 2018 Feb 26.

Reference Type DERIVED
PMID: 29480357 (View on PubMed)

Related Links

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ANTIBODY-RA

Identifier Type: OTHER

Identifier Source: secondary_id

B1801364

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Enbrel Liquid Immunogenicity Protocol
NCT00249041 COMPLETED PHASE3