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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 (MAINTAIN)

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ClinicalTrials.gov Identifier: NCT01692899
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : September 25, 2012
Sponsor:
Collaborator:
scientific steering committee of KOL in rheumatology
Information provided by (Responsible Party):
Pfizer

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
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 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 : June 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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



Primary Outcome Measures :
  1. Compare retention rates of adalimumab, etanercept and infliximab administered as first-line biologic therapy in RA [ Time Frame: 2 years ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
RA defined by the 1987 ACR criteria [18]; first TNFα inhibitor prescribed in the previously mentioned period; TNFα 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 TNFα inhibitor was prescribed in an RCT; or they refused to participate.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692899


Sponsors and Collaborators
Pfizer
scientific steering committee of KOL in rheumatology
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01692899     History of Changes
Other Study ID Numbers: NRB1800007
B1801356
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: September 25, 2012
Last Verified: September 2012

Keywords provided by Pfizer:
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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Etanercept
Infliximab
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors
Dermatologic Agents