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Trial record 2 of 531 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

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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Other: no intervention

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.

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Study Type : Observational
Actual Enrollment : 605 participants
Time Perspective: Cross-Sectional
Official Title: Anti-tnf Inhibitor Antibody-mediated Blockade Of Drug Efficacy In Rheumatoid Arthritis (Antibody-ra)
Study Start Date : January 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: no intervention
Other Name: Enbrel

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.
Other: no intervention
Other Name: Humira

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: no intervention
Other Name: Remicade




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. 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.

  10. 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.

  11. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981473


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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01981473     History of Changes
Other Study ID Numbers: B1801364
ANTIBODY-RA ( Other Identifier: Alias Study Number )
First Posted: November 11, 2013    Key Record Dates
Results First Posted: January 12, 2016
Last Update Posted: January 12, 2016
Last Verified: December 2015
Keywords provided by Pfizer:
rheumatoid arthritis
etanercept
adalimumab
infliximab
anti-drug antibody
immunogenicity
drug concentration
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Etanercept
Infliximab
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Immunosuppressive Agents