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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	17 October 2016
Main ID:	NCT02927535
Date of registration:	16/09/2016
Prospective Registration:	No
Primary sponsor:	Centre Hospitalier Universitaire de Nimes
Public title:	Evaluation of TNFa Blockers Monotherapy in Early Rheumatoid Arthritis in France
Scientific title:
Date of first enrolment:	January 2015
Target sample size:	813
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02927535
Study type:	Observational
Study design:	Observational Model: Cohort, Time Perspective: Prospective
Phase:	N/A

Countries of recruitment

Contacts

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: TNF blockers monotherapy

Primary Outcome(s)

Frequency of use of TNF blocker monotherapy [Time Frame: 12 months]

Frequency of use of TNF blocker monotherapy [Time Frame: 18 months]

Frequency of use of TNF blocker monotherapy [Time Frame: 6 months]

Frequency of use of TNF blocker monotherapy [Time Frame: baseline (day 0)]

Frequency of use of TNF blocker monotherapy [Time Frame: 24 months]

Frequency of use of TNF blocker monotherapy [Time Frame: 60 months]

Frequency of use of TNF blocker monotherapy [Time Frame: 48 months]

Frequency of use of TNF blocker monotherapy [Time Frame: 120 months]

Frequency of use of TNF blocker monotherapy [Time Frame: 36 months]

Secondary Outcome(s)

Secondary ID(s)

Bourse TNFblockers monotherapy

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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