A Study Evaluating the Safety and Efficacy of Cura-100 in Subjects With Rheumatoid Arthritis and Osteoarthritis
Recruitment status was Not yet recruiting
The purpose of the study is to evaluate the safety and efficacy of Cura-100 in treating rheumatoid arthritis and osteoarthritis.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study Evaluating Cura-100 in Rheumatoid Arthritis and Osteoarthritis|
- The primary outcome is remission of rheumatoid arthritis and osteoarthritis, which will be measured with ACR criteria.
- 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.
|Study Start Date:||May 2007|
|Estimated Study Completion Date:||December 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455208
|United States, California|
|Cura Biotech LLC||Not yet recruiting|
|Sunnyvale, California, United States, 94087|
|Contact: Victor Zhang 408-774-1832 firstname.lastname@example.org|
|Principal Investigator: Lizhen Wang, MD|
|Study Director:||Victor Zhang||Cura Biotech LLC|