Retention Rates of Adalimumab, Etanercept and Infliximab as First and Second-Line Biotherapy in Patients With Rheumatoid Arthritis in Daily Practice

NCT01692899

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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

- RA defined by the 1987 ACR criteria [18]

- first TNFα inhibitor prescribed in the previously mentioned period

- TNFα inhibitor prescribed as first-line biotherapy

- undergone at least one evaluation in the center after treatment initiation

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


- previously received another biotherapy


- TNFα inhibitor was prescribed in an RCT


- refused to participate

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Advanced Information
Descriptive Information
Brief Title Retention Rates of Adalimumab, Etanercept and Infliximab as First and Second-Line Biotherapy in Patients With Rheumatoid Arthritis in Daily Practice
Official Title Retention Rates of Adalimumab, Etanercept and Infliximab as First and Second-Line Biotherapy in Patients With Rheumatoid Arthritis in Daily Practice
Brief Summary To compare retention rates of adalimumab, etanercept and infliximab as first-line biotherapy in rheumatoid arthritis (RA), to determine causes of discontinuation, retention-associated factors, and retention rates of possible second-line tumor necrosis factor ? inhibitors (TNFi).
Detailed Description In this retrolective, multicentric study, medical charts of RA patients starting TNFi between March 2005 and April 2009 were reviewed, with follow-up between 2 and 6 years. The retention rate was estimated using the Kaplan-Meier method. Comparison between TNFi was done after adjustment using a Cox model. Factors associated with better retention were identified by multivariate analysis. Medical charts of all patients with RA starting a first TNF? inhibitor therapy between March 1, 2005 (start of commercialization of adalimumab in France) and April 30, 2009 (allowing at least 2 years of follow-up) were systematically reviewed in detail by 2 rheumatologist investigators
Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population RA defined by the 1987 ACR criteria [18]; first TNF? inhibitor prescribed in the previously mentioned period; TNF? inhibitor prescribed as first-line biotherapy; and patients had undergone at least one evaluation in the center after treatment initiation. Patients were excluded if: they had previously received another biotherapy; the TNF? inhibitor was prescribed in an RCT; or they refused to participate.
Condition Rheumatoid Arthritis
Intervention Not Provided
Study Groups/Cohorts
  • Etanercept
    Etanercept: administered as first line biotherapy in RA during the period of the study
  • Adalimumab
    Adalimumab: administered as first line biotherpy in RA during the period of the study
  • Infliximab
    Infliximab: administered as first line biotherpy in RA during the period of the study
Publications * Frazier-Mironer A, Dougados M, Mariette X, Cantagrel A, Deschamps V, Flipo RM, Logeart I, Schaeverbeke T, Sibilia J, Le Loët X, Combe B. Retention rates of adalimumab, etanercept and infliximab as first and second-line biotherapy in patients with rheumatoid arthritis in daily practice. Joint Bone Spine. 2014 Jul;81(4):352-9. doi: 10.1016/j.jbspin.2014.02.014. Epub 2014 Apr 8.

*   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: September 24, 2012)
780
Original Actual Enrollment Same as current
Actual Study Completion Date September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • RA defined by the 1987 ACR criteria [18]
  • first TNF? inhibitor prescribed in the previously mentioned period
  • TNF? inhibitor prescribed as first-line biotherapy
  • undergone at least one evaluation in the center after treatment initiation

Exclusion Criteria:

  • previously received another biotherapy
  • TNF? inhibitor was prescribed in an RCT
  • refused to participate
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01692899
Other Study ID Numbers NRB1800007
B1801356
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators scientific steering committee of KOL in rheumatology
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2012