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

NCT01692899 | Completed

• 2 other identifiers: NRB1800007B1801356
• Study Type: observational
• Target: 780
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Rheumatoid Arthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (4)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• previously received another biotherapy
• TNFα inhibitor was prescribed in an RCT
• refused to participate

Sponsors & Collaborators

• Pfizer: lead
• scientific steering committee of KOL in rheumatology: collaborator

Related Publications (1)

• Frazier-Mironer A, Dougados M, Mariette X, Cantagrel A, Deschamps V, Flipo RM, Logeart I, Schaeverbeke T, Sibilia J, Le Loet X, Combe B. Retention rates of adalimumab, etanercept and infliximab as first and second-line biotherapy in patients with rheumatoid arthritis in daily practice. Joint Bone Spine. 2014 Jul;81(4):352-9. doi: 10.1016/j.jbspin.2014.02.014. Epub 2014 Apr 8.

  PMID: 24721422 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: September 25, 2012
• Study Start: June 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 25, 2012

Record last verified: 2012-09