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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided by Pfizer

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

ClinicalTrials.gov processed this record on November 23, 2014