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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
Timepoint [9] 0 0
1 day
Secondary outcome [10] 0 0
Correlation of Antidrug Antibody Titers With Efficacy Measures.
Timepoint [10] 0 0
1 day
Secondary outcome [11] 0 0
Correlation of Antidrug Antibody Titers With Trough Drug Concentration.
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
Sex
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
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
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
605
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01981473