Osteoarthritis, Rheumatoid Arthritis
Conditions
Brief summary
The purpose of the study is to evaluate the safety and efficacy of Cura-100 in treating rheumatoid arthritis and osteoarthritis.
Detailed description
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.
Interventions
DRUGCura-100
Sponsors
Cura Biotech LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Having a diagnosis of rheumatoid arthritis and osteoarthritis at active stage * Able and willing to comply with study visits and procedures specified in this protocol for at least six months period * Able to understand and willing to sign and date the written informed consent form prior to admission of the study * Able and willing to provide adequate information for locator purposes * Able and willing to provide self evaluation information and diagnostic report of arthritis as required for efficacy evaluation
Exclusion criteria
* Pregnant women * Over-weighted * Hypertension, or diabetes, or a history of cardiovascular disease or kidney disease, or serious skin allergy or other concurrent clinically significant illness or medical condition (other than arthritis) which, in the viewpoint of the study doctor, may put the subject at a possible risk for participation * Patients used biologic modifier therapy or currently taking immunosuppressive agents might be excluded * Unable to spend 3 hours for treatment at the study center
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is remission of rheumatoid arthritis and osteoarthritis, which will be measured with ACR criteria. | — |
Secondary
| Measure | 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. | — |
Countries
United States
Outcome results
None listed