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

NCT01981473

Last updated date
Study Location
Arizona Arthritis & Rheumatology
Glendale, Arizona, 85304, United States
Contact
1-800-718-1021

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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).

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Advanced Information
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 * Bassiouni H, Spargo CE, Vlahos B, Jones HE, Pedersen R, Shirazy K. Maintenance of Remission with Etanercept-DMARD Combination Therapy Compared with DMARDs Alone in African and Middle Eastern Patients with Active Rheumatoid Arthritis. Rheumatol Ther. 2018 Jun;5(1):149-158. doi: 10.1007/s40744-018-0094-6. Epub 2018 Feb 26.

*   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,   Australia,   Bulgaria,   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 CenterPfizer
PRS Account Pfizer
Verification Date December 2015