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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02927535
Other study ID # Bourse TNFblockers monotherapy
Secondary ID
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. completion date
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


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
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