NCT01981473CompletedNot Applicable
Anti-tnf Inhibitor Antibody-mediated Blockade Of Drug Efficacy In Rheumatoid Arthritis (Antibody-ra)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 605
- Locations
- 53
- Primary Endpoint
- Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab).
Study Overview
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.
Study Design
- Study Type
- Observational
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older.
- •Diagnosis of RA based on the 1987 American College of Rheumatology revised criteria
- •Current continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months and maximum of 24 months.
Exclusion Criteria
- •Treatment with biosimilar or investigational etanercept, adalimumab, or infliximab within past 6 months.
- •Treatment with any other investigational drugs within past 3 months or five half lives of the drug, whichever is longer.
- •Any medical condition that would interfere with rheumatoid arthritis evaluation or other study assessments (eg, fibromyalgia, lupus).
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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).(1 day)
- Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab.(1 Day)
- Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.(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.(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.(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.(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.(1 day)
- Correlation of Antidrug Antibody Titers With Trough Drug Concentration.(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.(1 day)
- Percentage of 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.(1 day)
Investigators
Study Sites (53)
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