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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00291915 |
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Date of registration:
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14/02/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Multicenter Randomized Prospective Trial Comparing Methotrexate Alone or in Combination With Adalimumab in Early Arthritis
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Scientific title:
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Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis |
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Date of first enrolment:
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May 2004 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00291915 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Maxime DOUGADOS, md |
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Address:
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Telephone:
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00 33 1 58 41 25 62 |
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Email:
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maxime.dougados@cch.aphp.fr |
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Affiliation:
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Name:
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Maxime DOUGADOS, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hopital Cochin Paris FRance |
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Name:
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Maxime r DOUGADOS, MD |
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Address:
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Telephone:
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00 33 1 58 41 25 62 |
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Email:
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maxime.dougados@cch.aphp.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Early Active Potentially severe arthritis
Exclusion Criteria:
- contra indication of methotrexate or anti TNF
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Arthritis
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Adalimumab
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Drug: Methotrexate
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Primary Outcome(s)
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Disease Activity Score
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Secondary Outcome(s)
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-Pain (VAS)
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-Functional impairment ( HAQ)
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-Radiological score
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Secondary ID(s)
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GUEPARD-GERCER 2122
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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