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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)

This study has been completed.
Sponsor:
Collaborator:
scientific steering committee of KOL in rheumatology
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01692899
First received: September 21, 2012
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Phase
Rheumatoid Arthritis
 Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Compare retention rates of adalimumab, etanercept and infliximab administered as first-line biologic therapy in RA [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare retention rates of TNFα inhibitor monoclonal antibodies (adalimumab and infliximab) and the soluble receptor (etanercept) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Causes of discontinuing these treatments [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Determine the factors associated with better retention of the first TNFα inhibitors [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Compare retention rates of possible second-line TNFα inhibitors [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Enrollment: 780
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692899

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01692899     History of Changes
Other Study ID Numbers: NRB1800007, B1801356
Study First Received: September 21, 2012
Last Updated: September 24, 2012
Health Authority: France: The Commission nationale de l’informatique et des libertés
France: Conseil National de l'Or

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
Urinary Retention
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Urination Disorders
Urologic Diseases
TNFR-Fc fusion protein
Infliximab
Adalimumab
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013