Evaluation of TNFα Blockers Monotherapy in Early Rheumatoid Arthritis in France

NCT02927535 | Completed

• 1 other identifier: Bourse TNFblockers monotherapy
• Study Type: observational
• Target: 813
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim: To describe 1) The use of TNF blockers monotherapy in early arthritis in daily clinical practice in France 2) To evaluate symptomatic, structural efficacy, and retention rate over 5 years of TNF blockers monotherapy 3) To evaluate predictive factors for TNF blocker response monotherapy Type of study: Observational cohort study using cross-section and longitudinal data. Description of the project methodology

• Patients: All patients in the ESPOIR cohort (multicentre French cohort study of early RA).A sub-analysis will be conducted among patients satisfying the ACR-EULAR 2010 criteria.
• Data collected: Patient characteristics, Clinical data regarding RA and related pathologies, Characteristics of treatments received The analysis will be conducted using data collected at baseline, 6, 12, 18, 24, 36, 48, 60 months.
• Analyses:
• Frequency of use of TNF blockers monotherapy: we will calculate the % of patients initiating TNF blockers monotherapy (Kaplan-Meier method), and we will describe the type of TNF blocker, the route of administration, the dosage, and the place of the TNF blockers monotherapy in the treatment strategy during the first 5 years.
• Identification of potential predictive factors for initiation of TNF blockers monotherapy: a survival curve (Kaplan-Meier) will be performed. The baseline characteristics of the patients with regard to the initiation of TNF blocker monotherapy during the first 5 years of the disease will be compared by univariate analysis and Log-rank test will be performed in all variables. A stepwise multivariate analysis (Cox analysis) will be performed.
• Therapeutical effect: we will calculate the retention rate over time, and will compare the changes in different variables in the group of patients who have received TNF blockers monotherapy matched (using a propensity score) to 1,2 or 3 patients who have received TNF blockers in combination with synthetic DMARDs. We will assess and compare DAS28 and HAQ at short term (after at least 8 weeks of treatment) and long term (last available visit) in groups. The structural efficacy was evaluated by the radiographic progression at last available visit. We will identically estimate the drug effect depending on the TNF blocker used, by calculating the retention rate and comparing DAS28 at short term and long term.
• Identification of predictive factors for TNF blocker monotherapy response: To evaluate the impact of baseline demographics and disease conditions on the DAS28 and HAQ response during the first 5 years will be compared by univariate and multivariate analysis.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (9)

• Frequency of use of TNF blocker monotherapy

  baseline (day 0)

• Frequency of use of TNF blocker monotherapy

  6 months

• Frequency of use of TNF blocker monotherapy

  12 months

• Frequency of use of TNF blocker monotherapy

  18 months

• Frequency of use of TNF blocker monotherapy

  24 months

• Frequency of use of TNF blocker monotherapy

  36 months

• Frequency of use of TNF blocker monotherapy

  48 months

• Frequency of use of TNF blocker monotherapy

  60 months

• Frequency of use of TNF blocker monotherapy

  120 months

Interventions

TNF blockers monotherapy DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients in the ESPOIR cohort (multicentre French cohort study of early RA). A sub-analysis will be conducted among patients satisfying the ACR-EULAR 2010 criteria.

You may qualify if:

• age 18 to 70 years
• more than 2 swollen joints for \>6 weeks and \<6 months
• suspected or confirmed diagnosis of RA
• no previous intake of DMARDs or steroids (except if \<2 weeks).

You may not qualify if:

• Patients were excluded if the referring physician judged they had other clearly defined inflammatory rheumatic diseases.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• Pfizer: collaborator

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: October 7, 2016
• Study Start: January 1, 2015
• Primary Completion: September 1, 2016
• Last Updated: October 7, 2016

Record last verified: 2016-09