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The purpose of the study is to evaluate the safety and efficacy of Cura-100 in treating rheumatoid arthritis and osteoarthritis.
This is the Phase I/II trial, which monitors both safety and efficacy of Cura-100 in subjects with rheumatoid arthritis and osteoarthritis at one clinical study center. The open-label clinical study will be used in the study. The study is expected to last for one and a half year after it has been officially started, which include recruitment, study treatment and follow-ups. The healthy volunteers are also included to study the safety of the intervention.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cura-100 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome is remission of rheumatoid arthritis and osteoarthritis, which will be measured with ACR criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary outcome is the reduction in signs and symptoms of rheumatoid arthritis and osteoarthritis for a continuous three or six month period, measured with ACR20 and the change from baseline in HAQ. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor Zhang | Cura Biotech LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cura Biotech LLC | Sunnyvale | California | 94087 | United States |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |