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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01981473
Registration number
NCT01981473
Ethics application status
Date submitted
5/11/2013
Date registered
11/11/2013
Date last updated
12/01/2016
Titles & IDs
Public title
Drug Concentration, Immunogenicity, and Efficacy Study in Patients With Rheumatoid Arthritis Currently Treated With Etanercept, Adalimumab, or Infliximab
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Scientific title
Anti-tnf Inhibitor Antibody-mediated Blockade Of Drug Efficacy In Rheumatoid Arthritis (Antibody-ra)
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Secondary ID [1]
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ANTIBODY-RA
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Secondary ID [2]
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B1801364
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Universal Trial Number (UTN)
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Trial acronym
ANTIBODY-RA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - no intervention
Other interventions - no intervention
Other interventions - no intervention
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.
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.
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 interventions: no intervention
Other interventions: no intervention
Other interventions: no intervention
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab).
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Assessment method [1]
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Percentage of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab) was determined.
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Timepoint [1]
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1 day
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Secondary outcome [1]
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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).
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Assessment method [1]
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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).
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Timepoint [1]
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1 day
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Secondary outcome [2]
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Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
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Assessment method [2]
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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.
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Timepoint [2]
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1 day
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Secondary outcome [3]
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Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab.
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Assessment method [3]
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Percentage of participants positive for antidrug antibodies among those treated with etanercept, adalimumab, or infliximab were determined.
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Timepoint [3]
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1 Day
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Secondary outcome [4]
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The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
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Assessment method [4]
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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.
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Timepoint [4]
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1 Day
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Secondary outcome [5]
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The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
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Assessment method [5]
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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.
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Timepoint [5]
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1 day
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Secondary outcome [6]
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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.
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Assessment method [6]
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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.
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Timepoint [6]
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1 day
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Secondary outcome [7]
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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.
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Assessment method [7]
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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.
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Timepoint [7]
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1 day
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Secondary outcome [8]
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Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
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Assessment method [8]
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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).
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Timepoint [8]
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1 day
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Secondary outcome [9]
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Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
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Assessment method [9]
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HAQ DI (<=0.5) scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative.
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Timepoint [9]
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1 day
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Secondary outcome [10]
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Correlation of Antidrug Antibody Titers With Efficacy Measures.
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Assessment method [10]
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Correlation of antidrug antibody titers with efficacy measures analysed using Spearman correlation coefficient.
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Timepoint [10]
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1 day
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Secondary outcome [11]
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Correlation of Antidrug Antibody Titers With Trough Drug Concentration.
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Assessment method [11]
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Correlation of antidrug antibody titers with trough drug concentration analysed using Spearman correlation coefficient.
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Timepoint [11]
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1 day
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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).
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Study design
Purpose
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Duration
Cross-sectional
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2014
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Sample size
Target
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Accrual to date
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Final
605
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Recruitment in Australia
Recruitment state(s)
TAS
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Recruitment hospital [1]
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Southern Clinical Research Pty Ltd - Sandy Bay, Hobart
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Recruitment postcode(s) [1]
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7000 - Sandy Bay, Hobart
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Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Delaware
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Florida
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Georgia
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Kansas
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Maryland
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Massachusetts
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Missouri
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Nebraska
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Argentina
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Buenos Aires / Argentina
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Buenos Aires
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Ciudad Autónoma de Buenos Aires / Buenos Aires /Argentina.
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Argentina
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Ciudad de Buenos Aires, Buenos Aires, Argentina
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Argentina
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Mendoza / Argentina
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Bulgaria
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Burgas
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Adana
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Turkey
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Ankara
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Turkey
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Erzurum
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Turkey
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Eskisehir
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01981473
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01981473
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