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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01692899

Collaborator

scientific steering committee of KOL in rheumatology (Other)

780

Enrollment

Duration (Months)

Study Details

Study Description

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 α inhibitors (TNFi).

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis

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 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

Study Design

Study Type:

Observational

Actual Enrollment :

780 participants

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Compare retention rates of adalimumab, etanercept and infliximab administered as first-line biologic therapy in RA [2 years]

Secondary Outcome Measures

Compare retention rates of TNFα inhibitor monoclonal antibodies (adalimumab and infliximab) and the soluble receptor (etanercept) [4 years]
Causes of discontinuing these treatments [4 years]
Determine the factors associated with better retention of the first TNFα inhibitors [4 years]
Compare retention rates of possible second-line TNFα inhibitors [4 years]