Evaluation of TNFα Blockers Monotherapy in Early Rheumatoid Arthritis in France

Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927535
• Other study ID #: Bourse TNFblockers monotherapy
• Status: Completed
• Phase: N/A
• First received: September 16, 2016
• Last updated: October 6, 2016
• Start date: January 2015

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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:

1. 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.

2. 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.

3. 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.

4. 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.

Expected results:

Increase knowledge on the use of TNF blocker monotherapy, its efficacy and retention rate, and on predictive factors for TNF blocker monotherapy response in early RA patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 813
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• TNF blockers monotherapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of use of TNF blocker monotherapy		baseline (day 0)	No
Primary	Frequency of use of TNF blocker monotherapy		6 months	No
Primary	Frequency of use of TNF blocker monotherapy		12 months	No
Primary	Frequency of use of TNF blocker monotherapy		18 months	No
Primary	Frequency of use of TNF blocker monotherapy		24 months	No
Primary	Frequency of use of TNF blocker monotherapy		36 months	No
Primary	Frequency of use of TNF blocker monotherapy		48 months	No
Primary	Frequency of use of TNF blocker monotherapy		60 months	No
Primary	Frequency of use of TNF blocker monotherapy		120 months	No