Clinical trial NCT01981473: Drug Concentration, Immunogenicity, and Efficacy Study in Patients With Rheumatoid Arthritis Currently Treated With Etanercept, Adalimumab, or Infliximab
Official title: Anti-tnf Inhibitor Antibody-mediated Blockade Of Drug Efficacy In Rheumatoid Arthritis (Antibody-ra)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
etanercept
adalimumab
infliximab
anti-drug antibody
immunogenicity
drug concentration
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-11-11
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
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

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab).
timeFrame: 1 day
Secondary outcomes:
measure: 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).
timeFrame: 1 day
measure: Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
timeFrame: 1 day
measure: Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab.
timeFrame: 1 Day
measure: The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
timeFrame: 1 Day
measure: The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
timeFrame: 1 day
measure: 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.
timeFrame: 1 day
measure: 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.
timeFrame: 1 day
measure: Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
timeFrame: 1 day
measure: Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
timeFrame: 1 day
measure: Correlation of Antidrug Antibody Titers With Efficacy Measures.
timeFrame: 1 day
measure: Correlation of Antidrug Antibody Titers With Trough Drug Concentration.
timeFrame: 1 day
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P. C.
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis and Rheumatology Research, PLLC
state: Arizona
city: Sun City
country: United States
facility: Arizona Arthritis & Rheumatology Research
state: Arizona
city: Hot Springs
country: United States
facility: Mercy Clinic Hot Springs Communities
state: Arkansas
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: San Jose
country: United States
facility: Arthritis Care Center, Incorporated
state: California
city: Lewes
country: United States
facility: Rheumatology Consultants of Delaware dba Delaware Arthritis
state: Delaware
city: Debary
country: United States
facility: Omega Research Consultants, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Center for Rheumatology, Immunology, and Arthritis
state: Florida
city: Gainesville
country: United States
facility: Florida Medical Research
state: Florida
city: South Miami
country: United States
facility: Arthritis and Rheumatic Care Center
state: Florida
city: Tampa
country: United States
facility: Health Point Medical Group, Inc.
state: Florida
city: Gainesville
country: United States
facility: Northeast Georgia Diagnostic Clinic, LLC
state: Georgia
city: Wichita
country: United States
facility: Via Christi Hospitals Wichita, Inc.
state: Kansas
city: Baltimore
country: United States
facility: Rheumatology Associates of Baltimore
state: Maryland
city: Fall River
country: United States
facility: Phase III Clinical Research
state: Massachusetts
city: Florissant
country: United States
facility: David S. Rosenberg, M.D
state: Missouri
city: Lincoln
country: United States
facility: Dr Melvin Albert Churchill Jr
state: Nebraska
city: Midland Park
country: United States
facility: Prospect Medical Offices
state: New Jersey
city: Brooklyn
country: United States
facility: Advanced Arthritis Care Center
state: New York
city: Plainview
country: United States
facility: Prem C.Chatpar, M.D., LLC
state: New York
city: Charlotte
country: United States
facility: Box Arthritis and Rheumatology
state: North Carolina
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading, LLC
state: Pennsylvania
city: North Charleston
country: United States
facility: Low Country Rheumatology, PA
state: South Carolina
city: Hendersonville
country: United States
facility: Comprehensive Rheumatology Care
state: Tennessee
city: Hixon
country: United States
facility: Elizabeth Marini Simpson
state: Tennessee
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: Houston
country: United States
facility: Clinical Research Institute of Houston
state: Texas
city: Tomball
country: United States
facility: Spring Clinical Research
state: Texas
city: Chesapeake
country: United States
facility: Center for Arthritis and Rheumatic Diseases, P.C.
state: Virginia
city: Spokane
country: United States
facility: Arthritis Northwest, PLLC
state: Washington
city: Ciudad Autónoma de Buenos Aires / Buenos Aires
country: Argentina
facility: Sociedad Italiana de Beneficencia en Buenos Aires (Hospital Italiano de Buenos Aires)
state: Buenos Aires / Argentina
city: San Fernando
country: Argentina
facility: Instituto de Asistencia Reumatológica Integral I.A.R.I
state: Buenos Aires / Argentina
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires / Buenos Aires
country: Argentina
facility: Clínica Adventista Belgrano
state: Ciudad Autónoma de Buenos Aires / Buenos Aires /Argentina.
city: Ciudad de Buenos Aires / Buenos Aires
country: Argentina
facility: CIER, centro de investigaciones en enfermedades reumáticas (Razón social: ARIES MEDICA S.R.L.)
state: Ciudad de Buenos Aires, Buenos Aires, Argentina
city: Godoy Cruz
country: Argentina
facility: Sociedad Española de Beneficiencia y Mutualidad Hospital español de Mendoza
state: Mendoza / Argentina
city: Ramos Mejía
country: Argentina
facility: DIM Clinica Privada
state: Ramos Mejía / Buenos Aires / Argentina
city: S.M. de Tucumán / Tucumán
country: Argentina
facility: Centro Integral de Reumatología S.R.L.
state: S.M. de Tucumán / Tucumán / Argentina.
city: San Juan
country: Argentina
facility: C.E.R - Centro Polivalente de Asistencia e Investigación Clínica propiedad de CER SAN JUAN S.R.L.
state: San Juan / San Juan / Buenos Aires
city: Rosario
country: Argentina
facility: Instituto CAICI SRL.
state: Santa Fe / Argentina
city: Santa Fé
country: Argentina
facility: I.N.Ne.L S.R.L. (Instituto de Neurología y Neurorrehabilitación del Litoral S.R.L.)
state: Santa Fé / Argentina
city: Sandy Bay, Hobart
country: Australia
facility: Southern Clinical Research Pty Ltd
state: Tasmania
city: Burgas
country: Bulgaria
facility: MHAT Burgas
city: Pleven
country: Bulgaria
facility: DCC Sveti Pantaleimon OOD
city: Plovdiv
country: Bulgaria
facility: MHAT Kaspela EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv.Ivan Rilski"
city: Adana
country: Turkey
facility: Cukurova Universitesi Tip Fakultesi Balcalı Hastanesi
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi
city: Erzurum
country: Turkey
facility: Ataturk Universitesi Yakutiye Egitim ve Arastirma Hastanesi
city: Eskisehir
country: Turkey
facility: Osmangazi Universitesi Tıp Fakultesi Hastanesi
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.