Drug Concentration, Immunogenicity, and Efficacy Study in Patients With Rheumatoid Arthritis Currently Treated With Etanercept, Adalimumab, or Infliximab (ANTIBODY-RA)

December 8, 2015 updated by: Pfizer

Anti-tnf Inhibitor Antibody-mediated Blockade Of Drug Efficacy In Rheumatoid Arthritis (Antibody-ra)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

605

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

  • Argentina
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
        • Hospital Británico de Buenos Aires
    • Buenos Aires / Argentina
      • Ciudad Autónoma de Buenos Aires / Buenos Aires, Buenos Aires / Argentina, Argentina, C1181ACH
        • Sociedad Italiana de Beneficencia en Buenos Aires (Hospital Italiano de Buenos Aires)
      • San Fernando, Buenos Aires / Argentina, Argentina, 1646
        • Instituto de Asistencia Reumatológica Integral I.A.R.I
    • Ciudad Autónoma de Buenos Aires / Buenos Aires /Argentina.
      • Ciudad Autónoma de Buenos Aires / Buenos Aires, Ciudad Autónoma de Buenos Aires / Buenos Aires /Argentina., Argentina, C1430EGF
        • Clinica Adventista Belgrano
    • Ciudad de Buenos Aires, Buenos Aires, Argentina
      • Ciudad de Buenos Aires / Buenos Aires, Ciudad de Buenos Aires, Buenos Aires, Argentina, Argentina, C1055AAF
        • CIER, centro de investigaciones en enfermedades reumáticas (Razón social: ARIES MEDICA S.R.L.)
    • Mendoza / Argentina
      • Godoy Cruz, Mendoza / Argentina, Argentina, M5501AAJ
        • Sociedad Española de Beneficiencia y Mutualidad Hospital español de Mendoza
    • Ramos Mejía / Buenos Aires / Argentina
      • Ramos Mejía, Ramos Mejía / Buenos Aires / Argentina, Argentina, B1704ETD
        • DIM Clínica Privada
    • S.M. de Tucumán / Tucumán / Argentina.
      • S.M. de Tucumán / Tucumán, S.M. de Tucumán / Tucumán / Argentina., Argentina, 4000
        • Centro Integral de Reumatología S.R.L.
    • San Juan / San Juan / Buenos Aires
      • San Juan, San Juan / San Juan / Buenos Aires, Argentina, J5402DIL
        • C.E.R - Centro Polivalente de Asistencia e Investigación Clínica propiedad de CER SAN JUAN S.R.L.
    • Santa Fe / Argentina
      • Rosario, Santa Fe / Argentina, Argentina, S2000PBJ
        • Instituto Caici Srl.
    • Santa Fé / Argentina
      • Santa Fé, Santa Fé / Argentina, Argentina, S3000ASL
        • I.N.Ne.L S.R.L. (Instituto de Neurología y Neurorrehabilitación del Litoral S.R.L.)
  • Australia
    • Tasmania
      • Sandy Bay, Hobart, Tasmania, Australia, 7000
        • Southern Clinical Research Pty Ltd
  • Bulgaria
      • Burgas, Bulgaria, 8000
        • MHAT Burgas
      • Pleven, Bulgaria, 5800
        • DCC Sveti Pantaleimon OOD
      • Plovdiv, Bulgaria, 4000
        • MHAT Kaspela EOOD
      • Sofia, Bulgaria, 1612
        • UMHAT "Sv.Ivan Rilski"
  • Turkey
      • Adana, Turkey, 01030
        • Cukurova Universitesi Tip Fakultesi Balcalı Hastanesi
      • Ankara, Turkey, 06100
        • Hacettepe Universitesi Tip Fakultesi Hastanesi
      • Erzurum, Turkey, 25240
        • Ataturk Universitesi Yakutiye Egitim ve Arastirma Hastanesi
      • Eskisehir, Turkey, 26480
        • Osmangazi Universitesi Tıp Fakultesi Hastanesi
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Arizona Arthritis & Rheumatology
      • Mesa, Arizona, United States, 85202
        • Arizona Arthritis & Rheumatology Associates, P. C.
      • Phoenix, Arizona, United States, 85032
        • Arizona Arthritis and Rheumatology Research, PLLC
      • Phoenix, Arizona, United States, 85032
        • Arizona Arthritis & Rheumatology
      • Sun City, Arizona, United States, 85351
        • Arizona Arthritis & Rheumatology Research
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Mercy Clinic Hot Springs Communities
    • California
      • Sacramento, California, United States, 95816
        • Sutter Institute for Medical Research
      • San Jose, California, United States, 95035
        • Arthritis Care Center, Incorporated
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Rheumatology Consultants of Delaware dba Delaware Arthritis
    • Florida
      • Debary, Florida, United States, 32713
        • Omega Research Consultants, LLC
      • Fort Lauderdale, Florida, United States, 33309
        • Center for Rheumatology, Immunology, and Arthritis
      • Gainesville, Florida, United States, 32607
        • Florida Medical Research
      • South Miami, Florida, United States, 33143
        • Arthritis and Rheumatic Care Center
      • Tampa, Florida, United States, 33614
        • Health Point Medical Group, Inc.
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Diagnostic Clinic, LLC
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Via Christi Hospitals Wichita, Inc.
    • Maryland
      • Baltimore, Maryland, United States, 21286
        • Rheumatology Associates of Baltimore
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Phase Iii Clinical Research
    • Missouri
      • Florissant, Missouri, United States, 63031
        • David S. Rosenberg, M.D
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Dr Melvin Albert Churchill Jr
    • New Jersey
      • Midland Park, New Jersey, United States, 07432
        • Prospect Medical Offices
    • New York
      • Brooklyn, New York, United States, 11235
        • Advanced Arthritis Care Center
      • Plainview, New York, United States, 11803
        • Prem C.Chatpar, M.D., LLC
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Box Arthritis and Rheumatology
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
        • Clinical Research Center of Reading, LLC
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Low Country Rheumatology, PA
    • Tennessee
      • Hendersonville, Tennessee, United States, 37075
        • Comprehensive Rheumatology Care
      • Hixon, Tennessee, United States, 37343
        • Elizabeth Marini Simpson
    • Texas
      • Austin, Texas, United States, 78731
        • Austin Regional Clinic
      • Houston, Texas, United States, 77084
        • Accurate Clinical Research
      • Houston, Texas, United States, 77090
        • Clinical Research Institute of Houston
      • Tomball, Texas, United States, 77375
        • Spring Clinical Research
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Center for Arthritis and Rheumatic Diseases, P.C.
    • Washington
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest, PLLC

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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).

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

  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other Names:
  • Remicade
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
Other Names:
  • Remicade
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
Other Names:
  • Remicade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab).
Time Frame: 1 day
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 1 day
Percentage of participants with Low Disease Activity (LDA) (Disease Activity Score based on a 28-joint count [DAS28] Erythrocyte sedimentation rate [ESR] score ≤3.2) among those who are antidrug antibody positive versus negative (all participants 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.
Time Frame: 1 day
Serum trough drug concentrations for etanercept, adalimumab, and infliximab compared between participants who are antidrug antibody positive versus negative. Units of measurement for Serum trough drug concentration is µg/mL.
1 day
Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab.
Time Frame: 1 Day
Percentage of participants positive for antidrug antibodies among those treated with etanercept, adalimumab, or infliximab were determined.
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.
Time Frame: 1 Day
The CDAI total scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. CDAI = Disease activity score (DAS) 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician's Global Assessment (0-10) + Subject's Global Assessment (0-10). The total score range is 0-76. Score interpretation: Remission ≤ 2.8; Low Disease Activity CDAI > 2.8 and ≤ 10; Moderate Disease Activity CDAI > 10 and ≤ 22; High Disease Activity CDAI > 22.
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.
Time Frame: 1 day
The SDAI Total Scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. SDAI = DAS 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician's Global Assessment (0-10) + Subject's Global Assessment (0-10) + C-reactive protein (CRP) (in mg/dL). The total score range is 0-86. Score interpretation: Remission SDAI ≤ 3.3; Low Disease Activity SDAI > 3.3 and ≤ 11; Moderate Disease Activity SDAI > 11 and ≤ 26; High Disease Activity SDAI > 26.
1 day
Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Time Frame: 1 day
The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0-100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0- 100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject's General Health VAS assessment.
1 day
Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Time Frame: 1 day
The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0 100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0-100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject's General Health VAS assessment.
1 day
Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Time Frame: 1 day
The HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do." Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. The total score range for the HAQ-DI scale, minimum score was 0 (best), maximum score was 3 (worst).
1 day
Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Time Frame: 1 day
HAQ DI (<=0.5) scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative.
1 day
Correlation of Antidrug Antibody Titers With Efficacy Measures.
Time Frame: 1 day
Correlation of antidrug antibody titers with efficacy measures analysed using Spearman correlation coefficient.
1 day
Correlation of Antidrug Antibody Titers With Trough Drug Concentration.
Time Frame: 1 day
Correlation of antidrug antibody titers with trough drug concentration analysed using Spearman correlation coefficient.
1 day

Collaborators and Investigators

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

Sponsor

Pfizer

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

January 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Estimate)

January 12, 2016

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1801364
  • ANTIBODY-RA (Other Identifier: Alias Study 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.

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