N/A
Completed N=605
Drug Concentration, Immunogenicity, and Efficacy Study in Patients With Rheumatoid Arthritis Currently Treated With Etanercept, Adalimumab, or Infliximab
Source: ClinicalTrials.gov NCT01981473 ↗Enrolled (actual)
605
Serious AEs
0.3%
Results posted
Jan 2016
Primary outcomePrimary: Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab). — 0; 24.4 Percentage of participants — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab). |
0; 24.4 | <0.0001 sig |
| SECONDARY 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). |
56.4; 62.0 | — |
| SECONDARY Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. |
NA; 1.5; 0.2; 1.8; 7.7; 9.8 | — |
| SECONDARY Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab. |
0; 31.2; 17.4 | — |
| SECONDARY The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. |
NA; 17.3; 21.7; 12.6; 16.3; 18.5 | — |
| SECONDARY The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. |
NA; 18.5; 23.1; 13.5; 16.8; 19.2 | — |
| SECONDARY 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. |
NA; 3.1; 3.5; 2.5; 2.8; 3.1 | — |
| SECONDARY 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. |
NA; 3.4; 3.7; 2.9; 3.1; 3.4 | — |
| SECONDARY Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. |
NA; 1.0; 1.2; 0.8; 0.9; 1.0 | — |
| SECONDARY Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. |
NA; 30.6; 20.6; 42.5; 36.5; 26.1 | — |
| SECONDARY Correlation of Antidrug Antibody Titers With Efficacy Measures. |
0.07447; 0.05256; 0.08970; 0.06806; 0.12179; 0.08950 | — |
| SECONDARY Correlation of Antidrug Antibody Titers With Trough Drug Concentration. |
-0.69017; -0.60542 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT01981473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.