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

NCT ID: NCT01692899

Last Updated: 2012-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

780 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-09-30

Brief Summary

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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 α inhibitors (TNFi).

Detailed Description

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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 TNFα 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

Conditions

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Rheumatoid Arthritis

Keywords

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Retention Rates of Adalimumab Etanercept and Infliximab as First and Second-Line Biotherapy in Patients with Rheumatoid Arthritis in Daily Practice. TNF inhibitors biotherapy retrospective study

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Etanercept

Etanercept: administered as first line biotherapy in RA during the period of the study

No interventions assigned to this group

Adalimumab

Adalimumab: administered as first line biotherpy in RA during the period of the study

No interventions assigned to this group

Infliximab

Infliximab: administered as first line biotherpy in RA during the period of the study

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

* previously received another biotherapy
* TNFα inhibitor was prescribed in an RCT
* refused to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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scientific steering committee of KOL in rheumatology

UNKNOWN

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

References

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Frazier-Mironer A, Dougados M, Mariette X, Cantagrel A, Deschamps V, Flipo RM, Logeart I, Schaeverbeke T, Sibilia J, Le Loet 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.

Reference Type DERIVED
PMID: 24721422 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=NRB1800007&StudyName=Retention%20Rates%20of%20Adalimumab%2C%20Etanercept%20and%20Infliximab%20as%20First%20and%20Second-Line%20Biotherapy%20in%20Patients%20with%20Rheumatoid%20Arthritis%20in%20

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Other Identifiers

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B1801356

Identifier Type: -

Identifier Source: secondary_id

NRB1800007

Identifier Type: -

Identifier Source: org_study_id