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OpenTrials
Completed

NCT Number: NCT01692899

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

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).

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Compare retention rates of adalimumab, etanercept and infliximab administered as first-line biologic therapy in RA

    Time frame: 2 years

Secondary outcomes

  1. Compare retention rates of TNFα inhibitor monoclonal antibodies (adalimumab and infliximab) and the soluble receptor (etanercept)

    Time frame: 4 years

  2. Causes of discontinuing these treatments

    Time frame: 4 years

  3. Determine the factors associated with better retention of the first TNFα inhibitors

    Time frame: 4 years

  4. Compare retention rates of possible second-line TNFα inhibitors

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • scientific steering committee of KOL in rheumatology

Registry information

Acronym: MAINTAIN

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 25, 2012
Registry last updated
Sep 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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