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Trial record 2 of 538 for:    Argentina | Bulgaria

Drug Concentration, Immunogenicity, and Efficacy Study in Patients With Rheumatoid Arthritis Currently Treated With Etanercept, Adalimumab, or Infliximab (ANTIBODY-RA)

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ClinicalTrials.gov Identifier: NCT01981473
Recruitment Status : Completed
First Posted : November 11, 2013
Results First Posted : January 12, 2016
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date November 5, 2013
First Posted Date November 11, 2013
Results First Submitted Date September 11, 2015
Results First Posted Date January 12, 2016
Last Update Posted Date January 12, 2016
Study Start Date January 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 8, 2015)
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.
Original Primary Outcome Measures
 (submitted: November 5, 2013)
Percentage of Patients Positive for Antidrug Antibodies Among Those Treated with etanercept Versus Those Treated with Monoclonal Antibodies (adalimumab or infliximab) [ Time Frame: 1 day ]
Change History Complete list of historical versions of study NCT01981473 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 8, 2015)
  • 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). [ Time Frame: 1 day ]
    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).
  • Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. [ Time Frame: 1 day ]
    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.
  • Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab. [ Time Frame: 1 Day ]
    Percentage of participants positive for antidrug antibodies among those treated with etanercept, adalimumab, or infliximab were determined.
  • The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. [ Time Frame: 1 Day ]
    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.
  • The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. [ Time Frame: 1 day ]
    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.
  • 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. [ Time Frame: 1 day ]
    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.
  • 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. [ Time Frame: 1 day ]
    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.
  • Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. [ Time Frame: 1 day ]
    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).
  • Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. [ Time Frame: 1 day ]
    HAQ DI (<=0.5) scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative.
  • Correlation of Antidrug Antibody Titers With Efficacy Measures. [ Time Frame: 1 day ]
    Correlation of antidrug antibody titers with efficacy measures analysed using Spearman correlation coefficient.
  • Correlation of Antidrug Antibody Titers With Trough Drug Concentration. [ Time Frame: 1 day ]
    Correlation of antidrug antibody titers with trough drug concentration analysed using Spearman correlation coefficient.
Original Secondary Outcome Measures
 (submitted: November 5, 2013)
  • Proportion of patients with Low Disease Activity (LDA) [ Time Frame: 1 Day ]
    LDA is defined as a Disease Activity Score using 28 joint count (DAS28) of ≤ 3.2. Patient DAS28 (ESR) score is calculated from the number of tender and swollen joints, erythrocyte sedimentation rate, and Subject General Health VAS assessment. Lower scores indicate better disease status.
  • Concentration of Serotype-Specific Antibodies [ Time Frame: 1 day ]
  • Proportion of Patients Positive for Antidrug Antibodies [ Time Frame: 1 Day ]
  • Clinical Disease Activity Index (CDAI) Scores [ Time Frame: 1 Day ]
    CDAI is calculated from DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician's Global Assessment (PGA) (0-10) + Subject's Global Assessment (0-10)
  • Simplified Disease Activity Index (SDAI) Scores [ Time Frame: 1 day ]
    SDAI is calculated from DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician's Global Assessment (PGA) (0-10) + Subject's Global Assessment (0-10) + c-reactive protein
  • Disease Activity Score, 28 Joint Count, calculated with erythrocyte sedimentation rate (DAS28-ESR) [ Time Frame: 1 day ]
    DAS28 (ESR) score is calculated from the number of tender and swollen joints, erythrocyte sedimentation rate, and Subject General Health VAS assessment.
  • Disease Activity Score, 28 Joint Count, calculated with c-reactive protein (DAS28-CRP) [ Time Frame: 1 day ]
    DAS28 (CRP) score is calculated from the number of tender and swollen joints, c-reactive protein, and Subject General Health VAS assessment.
  • Health Assessment Questionnaire (Disability and Discomfort Scales ) (HAQ-DI) Scores [ Time Frame: 1 day ]
    HAQ-DI is a questionnaire that assesses the degree of difficulty a patient has experienced during the past week in dressing, grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each question is answered with a level of difficulty score ranging from 0-3 with 0 representing "no difficulty" and 3 representing "unable to do".
  • Spearman's Correlation Coefficient of Antidrug Antibody Titers with DAS28-ESR [ Time Frame: 1 day ]
  • Spearman's Correlation Coefficient of Antidrug Antibody Titers with DAS28-CRP [ Time Frame: 1 Day ]
  • Spearman's Correlation Coefficient of Antidrug Antibody Titers with CDAI [ Time Frame: 1 day ]
  • Spearman's Correlation Coefficient of Antidrug Antibody Titers SDAI [ Time Frame: 1 day ]
  • Spearman's Correlation Coefficient of Antidrug Antibody Titers with Trough Drug Concentration [ Time Frame: 1 day ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Drug Concentration, Immunogenicity, and Efficacy Study in Patients With Rheumatoid Arthritis Currently Treated With Etanercept, Adalimumab, or Infliximab
Official Title Anti-tnf Inhibitor Antibody-mediated Blockade Of Drug Efficacy In Rheumatoid Arthritis (Antibody-ra)
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 Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Population will be selected from patients seen in a rheumatology clinical setting who currently treated with etanercept, adalimumab or infliximab for rheumatoid arthritis
Condition Rheumatoid Arthritis
Intervention
  • Other: no intervention
    Other Name: Enbrel
  • Other: no intervention
    Other Name: Humira
  • Other: no intervention
    Other Name: Remicade
Study Groups/Cohorts
  • 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.
    Intervention: Other: no intervention
  • 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.
    Intervention: Other: no intervention
  • 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.
    Intervention: Other: no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 31, 2015)
605
Original Estimated Enrollment
 (submitted: November 5, 2013)
600
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina,   Bulgaria,   Australia,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01981473
Other Study ID Numbers B1801364
ANTIBODY-RA ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2015