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Completed

NCT Number: NCT02927535

Evaluation of TNFα Blockers Monotherapy in Early Rheumatoid Arthritis in France

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TNF blockers monotherapy

Drug

Primary outcomes

  1. Frequency of use of TNF blocker monotherapy

    Time frame: baseline (day 0)

  2. Frequency of use of TNF blocker monotherapy

    Time frame: 6 months

  3. Frequency of use of TNF blocker monotherapy

    Time frame: 12 months

  4. Frequency of use of TNF blocker monotherapy

    Time frame: 18 months

  5. Frequency of use of TNF blocker monotherapy

    Time frame: 24 months

  6. Frequency of use of TNF blocker monotherapy

    Time frame: 36 months

  7. Frequency of use of TNF blocker monotherapy

    Time frame: 48 months

  8. Frequency of use of TNF blocker monotherapy

    Time frame: 60 months

  9. Frequency of use of TNF blocker monotherapy

    Time frame: 120 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • Pfizer

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 7, 2016
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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