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| Tracking Information | |||||
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| First Received Date ICMJE | September 25, 2003 | ||||
| Last Updated Date | May 5, 2009 | ||||
| Start Date ICMJE | October 2002 | ||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00069472 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Genetic Registry for Rheumatoid Arthritis | ||||
| Official Title ICMJE | Genetics of Rheumatoid Arthritis Registry | ||||
| Brief Summary | Many genes are thought to contribute to rheumatoid arthritis (RA). Currently only one such gene has been identified. This study will attempt to identify all of the genes that may contribute to RA and determine which specific genetic variations are responsible for the disease. |
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| Detailed Description | The identification of genes for complex disorders such as RA requires large numbers of genetically informative families. This study will enroll patients with RA and their families. This study will enroll 1000 RA patients and their parents. Participants with RA will be evaluated by a study official at his or her doctor's office or other location convenient for the participant. Participants will have a brief interview and physical exam and a blood sample will be obtained. Disease evaluation will be done at one visit and will include a 28 joint count, joint alignment and mobility score (JAMS), administration of a health assessment questionnaire and other related questionnaires. Physician confirmation of diagnosis will also be included in the disease evaluation. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Family-Based, Cross-Sectional | ||||
| Condition ICMJE | Rheumatoid Arthritis | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* 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 ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 3000 | ||||
| Estimated Completion Date | August 2009 | ||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00069472 | ||||
| Responsible Party | Peter K Gregersen, MD, The Feinstein Institute for Medical Research | ||||
| Study ID Numbers ICMJE | NIAMS-107 | ||||
| Study Sponsor ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Collaborators ICMJE | Arthritis Foundation | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Verification Date | May 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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