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To assess whether the anti-inflammatory effects of rosiglitazone result in improvements in Rheumatoid Arthritis symptoms in patients for whom their existing Disease Modifying Anti-Rheumatic Drug (DMARD) treatment does not give adequate relief.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rosiglitazone XR | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score (DAS) following 6 months of treatment | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease activity at 3 months and 6 months, e.g., number of affected joints Patient Assessments of Improvements in Disease Activity, e.g., fatigue and pain assessment Assessment of safety, tolerability and biological activity | Disease activity at 3 months and 6 months |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Kaunas | LT-45130 | Lithuania | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | This study has not been published in the scientific literature. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| ARA102198 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 6, 2017 | |
| Reset | Feb 1, 2018 | |
| Release | Mar 5, 2018 | |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 6, 2017 | Feb 1, 2018 | |||
| Mar 5, 2018 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Vilnius |
| LT-08661 |
| Lithuania |
| GSK Investigational Site | Glasgow | Lanarkshire | G12 0YN | United Kingdom |
| GSK Investigational Site | Glasgow | Lanarkshire | G21 3UW | United Kingdom |
| GSK Investigational Site | Glasgow | Lanarkshire | G31 2ER | United Kingdom |
For additional information about this study please refer to the GSK Clinical Study Register |
| ARA102198 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ARA102198 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ARA102198 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ARA102198 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ARA102198 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ARA102198 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |