Evaluation of Tumour Necrosis Factor Alpha (TNFα) Blockers in Early Rheumatoid Arthritis in France

NCT02927509

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Advanced Information
Descriptive Information
Brief Title Evaluation of Tumour Necrosis Factor Alpha (TNF?) Blockers in Early Rheumatoid Arthritis in France
Official Title Not Provided
Brief Summary

Aim: To describe 1) The use of TNF blockers in early arthritis in daily clinical practice in France 2) To evaluate symptomatic, structural efficacy, and retention rate over 5 years 3) To evaluate predictive factors for TNF blocker response 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 ACREULAR 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: the % of patients initiating TNF blockers will be calculated (Kaplan-Meier method), and the type of TNF blocker will be described, the route of administration, the dosage, the association with other DMARDs and the place of the TNF blockers in the treatment strategy during the first 5 years.
    2. Implementation of EULAR recommendations: the percentage of patients that initiate TNF blockers meeting the EULAR criteria for initiation will be estimated, and the concordance coefficient Kappa with regard to such fulfilment and the initiation of TNF blockers will be calculated, and disease severity outcome measures will be compared depending on the fulfilment or not.
    3. Identification of potential predictive factors for initiation of TNF blockers: a survival curve (Kaplan-Meier) will be performed. The baseline characteristics of the patients with regard to the initiation of TNF blocker 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.
    4. Therapeutical effect:the retention rate over time will be calculated, the changes in different variables will be compared in the group of patients who have received TNF blockers matched (using a propensity score) to 1,2 or 3 patients who have not. The DAS28 and HAQ will be assessed and compared at the 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.The drug effect will be identically estimated depending on the TNF blocker used, by calculating the retention rate and comparing DAS28 at short term and long term.

    6) Identification of predictive factors for TNF blocker 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 optimal use of TNF blocker and on predictive factors for TNF blocker response in early RA patients.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population - Patients: All patients in the ESPOIR cohort (multicentre French cohort study of early RA).A sub-analysis will be conducted among patients satisfying the ACREULAR 2010 criteria.
Condition Rheumatoid Arthritis
Intervention Drug: TNF alpha blockers
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 6, 2016)
813
Original Actual Enrollment Same as current
Study Completion Date Not Provided
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02927509
Other Study ID Numbers Bourse Passerelle TNF blockers
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire de N?mes
Study Sponsor Centre Hospitalier Universitaire de N?mes
Collaborators Pfizer
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire de N?mes
Verification Date September 2016