Evaluation of Tumour Necrosis Factor Alpha (TNFα) Blockers in Early Rheumatoid Arthritis in France
NCT02927509
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- 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).
- Patients were excluded if the referring physician judged they had other clearly
defined inflammatory rheumatic diseases.
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Descriptive Information | |||
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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
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 | 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:
Exclusion Criteria:
| ||
Sex/Gender |
| ||
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 |