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Tracking Information | |||||||||
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First Received Date † | February 14, 2006 | ||||||||
Last Updated Date | February 14, 2006 | ||||||||
Start Date † | May 2004 | ||||||||
Current Primary Outcome Measures † |
Disease Activity Score | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Multicenter Randomized Prospective Trial Comparing Methotrexate Alone or in Combination With Adalimumab in Early Arthritis | ||||||||
Official Title † | Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis | ||||||||
Brief Summary | Evaluation of two treatment modalities in early potentially severe early arthritis ( Methotrexate alone or in combination with adalimumab) |
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Detailed Description | Patients: early ( less than 6 months), active ( DAS>5.2),potentially severe ( Leiden score>6) Study design:12 months, prospective , randomized, open Study treatments: Methotrexate at a weekly dose of 0.3mg/kilo alone or in combination with adalimumab 40 mg every the other week Outcome measures: DAS over the 12 months |
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Study Phase | Phase IV | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 80 | ||||||||
Completion Date | March 2007 | ||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | France | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00291915 | ||||||||
Responsible Party | |||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Goupe d'Etudes et de Recherche Clinique En Rhumatologie | ||||||||
Collaborators †† | |||||||||
Investigators † |
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Information Provided By | Goupe d'Etudes et de Recherche Clinique En Rhumatologie | ||||||||
Verification Date | February 2006 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |