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

NCT01981473 | Completed Results

• 2 other identifiers: B1801364ANTIBODY-RA
• Study Type: observational
• Target: 605
• Locations: 5 countries
• Sites: 54

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; etanercept; adalimumab; infliximab; anti-drug antibody; immunogenicity; drug concentration

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab).

  Percentage of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab) was determined.

  1 day

Secondary Outcomes (11)

• Percentage of Participants With Low Disease Activity (LDA) (DAS28 ESR Score ≤ 3.2) Among Those Who Are Antidrug Antibody Positive Versus Negative (All Patients Receiving Etanercept, Adalimumab, or Infliximab Combined).

  1 day

• Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.

  1 day

• Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab.

  1 Day

• The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.

  1 Day

• The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.

  1 day

Study Arms (3)

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.

Other: no intervention

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.

Other: no intervention

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.

Other: no intervention

Interventions

no intervention OTHER

Also known as: Enbrel

etanercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population will be selected from patients seen in a rheumatology clinical setting who currently treated with etanercept, adalimumab or infliximab for rheumatoid arthritis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (54)

Arizona Arthritis & Rheumatology

Glendale, Arizona, 85304, United States

Location

Arizona Arthritis & Rheumatology Associates, P. C.

Mesa, Arizona, 85202, United States

Location

Arizona Arthritis & Rheumatology

Phoenix, Arizona, 85032, United States

Location

Arizona Arthritis and Rheumatology Research, PLLC

Phoenix, Arizona, 85032, United States

Location

Arizona Arthritis & Rheumatology Research

Sun City, Arizona, 85351, United States

Location

Mercy Clinic Hot Springs Communities

Hot Springs, Arkansas, 71913, United States

Location

Sutter Institute for Medical Research

Sacramento, California, 95816, United States

Location

Arthritis Care Center, Incorporated

San Jose, California, 95035, United States

Location

Rheumatology Consultants of Delaware dba Delaware Arthritis

Lewes, Delaware, 19958, United States

Location

Omega Research Consultants, LLC

DeBary, Florida, 32713, United States

Location

Center for Rheumatology, Immunology, and Arthritis

Fort Lauderdale, Florida, 33309, United States

Location

Florida Medical Research

Gainesville, Florida, 32607, United States

Location

Arthritis and Rheumatic Care Center

South Miami, Florida, 33143, United States

Location

Health Point Medical Group, Inc.

Tampa, Florida, 33614, United States

Location

Northeast Georgia Diagnostic Clinic, LLC

Gainesville, Georgia, 30501, United States

Location

Via Christi Hospitals Wichita, Inc.

Wichita, Kansas, 67214, United States

Location

Rheumatology Associates of Baltimore

Baltimore, Maryland, 21286, United States

Location

Phase III Clinical Research

Fall River, Massachusetts, 02720, United States

Location

David S. Rosenberg, M.D

Florissant, Missouri, 63031, United States

Location

Dr Melvin Albert Churchill Jr

Lincoln, Nebraska, 68516, United States

Location

Prospect Medical Offices

Midland Park, New Jersey, 07432, United States

Location

Advanced Arthritis Care Center

Brooklyn, New York, 11235, United States

Location

Prem C.Chatpar, M.D., LLC

Plainview, New York, 11803, United States

Location

Box Arthritis and Rheumatology

Charlotte, North Carolina, 28210, United States

Location

Clinical Research Center of Reading, LLC

Wyomissing, Pennsylvania, 19610, United States

Location

Low Country Rheumatology, PA

North Charleston, South Carolina, 29406, United States

Location

Comprehensive Rheumatology Care

Hendersonville, Tennessee, 37075, United States

Location

Elizabeth Marini Simpson

Hixon, Tennessee, 37343, United States

Location

Austin Regional Clinic

Austin, Texas, 78731, United States

Location

Accurate Clinical Research

Houston, Texas, 77084, United States

Location

Clinical Research Institute of Houston

Houston, Texas, 77090, United States

Location

Spring Clinical Research

Tomball, Texas, 77375, United States

Location

Center for Arthritis and Rheumatic Diseases, P.C.

Chesapeake, Virginia, 23320, United States

Location

Arthritis Northwest, PLLC

Spokane, Washington, 99204, United States

Location

Hospital Británico de Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina

Location

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

Ciudad Autónoma de Buenos Aires / Buenos Aires, Buenos Aires / Argentina, C1181ACH, Argentina

Location

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

San Fernando, Buenos Aires / Argentina, 1646, Argentina

Location

Clínica Adventista Belgrano

Ciudad Autónoma de Buenos Aires / Buenos Aires, Ciudad Autónoma de Buenos Aires / Buenos Aires /Argentina., C1430EGF, Argentina

Location

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, C1055AAF, Argentina

Location

Sociedad Española de Beneficiencia y Mutualidad Hospital español de Mendoza

Godoy Cruz, Mendoza / Argentina, M5501AAJ, Argentina

Location

DIM Clinica Privada

Ramos Mejía, Ramos Mejía / Buenos Aires / Argentina, B1704ETD, Argentina

Location

Centro Integral de Reumatología S.R.L.

S.M. de Tucumán / Tucumán, S.M. de Tucumán / Tucumán / Argentina., 4000, Argentina

Location

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, J5402DIL, Argentina

Location

Instituto CAICI SRL.

Rosario, Santa Fe / Argentina, S2000PBJ, Argentina

Location

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

Santa Fé, Santa Fé / Argentina, S3000ASL, Argentina

Location

Southern Clinical Research Pty Ltd

Sandy Bay, Hobart, Tasmania, 7000, Australia

Location

MHAT Burgas

Burgas, 8000, Bulgaria

Location

DCC Sveti Pantaleimon OOD

Pleven, 5800, Bulgaria

Location

MHAT Kaspela EOOD

Plovdiv, 4000, Bulgaria

Location

UMHAT "Sv.Ivan Rilski"

Sofia, 1612, Bulgaria

Location

Cukurova Universitesi Tip Fakultesi Balcalı Hastanesi

Adana, 01030, Turkey (Türkiye)

Location

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, 06100, Turkey (Türkiye)

Location

Ataturk Universitesi Yakutiye Egitim ve Arastirma Hastanesi

Erzurum, 25240, Turkey (Türkiye)

Location

Osmangazi Universitesi Tıp Fakultesi Hastanesi

Eskişehir, 26480, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 29480357 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept; Adalimumab; Infliximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 11, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 12, 2016
• Results First Posted: January 12, 2016

Record last verified: 2015-12

Locations

BU (4); TU (4); AR (11); US (34); AU (1)