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

Rheumatoid Arthritis Clinical Trial

— MAINTAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692899
• Other study ID #: NRB1800007
• Secondary ID: B1801356
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2012
• Last updated: September 24, 2012
• Start date: June 2011
• Est. completion date: September 2011

Study information

• Verified date: September 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertésFrance: Conseil National de l'Or
• Study type: Observational

Clinical Trial 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 α inhibitors (TNFi).

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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 780
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• RA defined by the 1987 ACR criteria [18]

• first TNFa inhibitor prescribed in the previously mentioned period

• TNFa inhibitor prescribed as first-line biotherapy

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

Exclusion Criteria:

• previously received another biotherapy

• TNFa inhibitor was prescribed in an RCT

• refused to participate

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	scientific steering committee of KOL in rheumatology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare retention rates of adalimumab, etanercept and infliximab administered as first-line biologic therapy in RA		2 years	No
Secondary	Compare retention rates of TNFa inhibitor monoclonal antibodies (adalimumab and infliximab) and the soluble receptor (etanercept)		4 years	No
Secondary	Causes of discontinuing these treatments		4 years	Yes
Secondary	Determine the factors associated with better retention of the first TNFa inhibitors		4 years	Yes
Secondary	Compare retention rates of possible second-line TNFa inhibitors		4 years	Yes

External Links

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