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Drug Concentration, Immunogenicity, and Efficacy Study in Patients With Rheumatoid Arthritis Currently Treated With Etanercept, Adalimumab, or Infliximab

Last updated on April 10, 2018

FOR MORE INFORMATION
Study Location
Arizona Arthritis & Rheumatology
Glendale, Arizona, 85304 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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).

NCT01981473
Pfizer
Completed
Drug Concentration, Immunogenicity, and Efficacy Study in Patients With Rheumatoid Arthritis Currently Treated With Etanercept, Adalimumab, or Infliximab

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Similar Trials

Drug Concentration, Immunogenicity, and Efficacy Study in Patients With Rheumatoid Arthritis Currently Treated With Etanercept, Adalimumab, or Infliximab
Anti-tnf Inhibitor Antibody-mediated Blockade Of Drug Efficacy In Rheumatoid Arthritis (Antibody-ra)
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.
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.
Observational
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample
Population will be selected from patients seen in a rheumatology clinical setting who currently treated with etanercept, adalimumab or infliximab for rheumatoid arthritis
Rheumatoid Arthritis
  • Other: no intervention
    Other Name: Enbrel
  • Other: no intervention
    Other Name: Humira
  • Other: no intervention
    Other Name: Remicade
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
605
December 2014
December 2014   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Bulgaria,   Turkey,   United States
 
 
NCT01981473
B1801364
ANTIBODY-RA ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2015

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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