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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
Anti-tnf Inhibitor Antibody-mediated Blockade Of Drug Efficacy In Rheumatoid Arthritis (Antibody-ra)
Secondary ID [1] 0 0
ANTIBODY-RA
Secondary ID [2] 0 0
B1801364
Universal Trial Number (UTN)
Trial acronym
ANTIBODY-RA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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


Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
1 day
Secondary outcome [1] 0 0
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). - 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).
Timepoint [1] 0 0
1 day
Secondary outcome [2] 0 0
Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. - 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.
Timepoint [2] 0 0
1 day
Secondary outcome [3] 0 0
Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab. - Percentage of participants positive for antidrug antibodies among those treated with etanercept, adalimumab, or infliximab were determined.
Timepoint [3] 0 0
1 Day
Secondary outcome [4] 0 0
The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. - 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.
Timepoint [4] 0 0
1 Day
Secondary outcome [5] 0 0
The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. - 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.
Timepoint [5] 0 0
1 day
Secondary outcome [6] 0 0
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. - 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.
Timepoint [6] 0 0
1 day
Secondary outcome [7] 0 0
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. - 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.
Timepoint [7] 0 0
1 day
Secondary outcome [8] 0 0
Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. - 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).
Timepoint [8] 0 0
1 day
Secondary outcome [9] 0 0
Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. - HAQ DI (<=0.5) scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative.
Timepoint [9] 0 0
1 day
Secondary outcome [10] 0 0
Correlation of Antidrug Antibody Titers With Efficacy Measures. - Correlation of antidrug antibody titers with efficacy measures analysed using Spearman correlation coefficient.
Timepoint [10] 0 0
1 day
Secondary outcome [11] 0 0
Correlation of Antidrug Antibody Titers With Trough Drug Concentration. - Correlation of antidrug antibody titers with trough drug concentration analysed using Spearman correlation coefficient.
Timepoint [11] 0 0
1 day

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 0 0
Southern Clinical Research Pty Ltd - Sandy Bay, Hobart
Recruitment postcode(s) [1] 0 0
7000 - Sandy Bay, Hobart
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires / Argentina
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Ciudad Autónoma de Buenos Aires / Buenos Aires /Argentina.
Country [24] 0 0
Argentina
State/province [24] 0 0
Ciudad de Buenos Aires, Buenos Aires, Argentina
Country [25] 0 0
Argentina
State/province [25] 0 0
Mendoza / Argentina
Country [26] 0 0
Argentina
State/province [26] 0 0
Ramos Mejía / Buenos Aires / Argentina
Country [27] 0 0
Argentina
State/province [27] 0 0
S.M. de Tucumán / Tucumán / Argentina.
Country [28] 0 0
Argentina
State/province [28] 0 0
San Juan / San Juan / Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Santa Fe / Argentina
Country [30] 0 0
Argentina
State/province [30] 0 0
Santa Fé / Argentina
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Burgas
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Pleven
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Plovdiv
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Sofia
Country [35] 0 0
Turkey
State/province [35] 0 0
Adana
Country [36] 0 0
Turkey
State/province [36] 0 0
Ankara
Country [37] 0 0
Turkey
State/province [37] 0 0
Erzurum
Country [38] 0 0
Turkey
State/province [38] 0 0
Eskisehir

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01981473
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications