Back to resultsA Study Evaluating the Safety and Efficacy of Cura-100 in Subjects With Rheumatoid Arthritis and Osteoarthritis
Primary Purpose
Rheumatoid Arthritis, Osteoarthritis
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cura-100
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
- Cura Biotech LLC
Outcomes
Primary Outcome Measures
The primary outcome is remission of rheumatoid arthritis and osteoarthritis, which will be measured with ACR criteria.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00455208
Brief Title
A Study Evaluating the Safety and Efficacy of Cura-100 in Subjects With Rheumatoid Arthritis and Osteoarthritis
Official Title
Study Evaluating Cura-100 in Rheumatoid Arthritis and Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Cura Biotech LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cura-100
Primary Outcome Measure Information:
Title
The primary outcome is remission of rheumatoid arthritis and osteoarthritis, which will be measured with ACR criteria.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Zhang
Organizational Affiliation
Cura Biotech LLC
Official's Role
Study Director
Facility Information:
Facility Name
Cura Biotech LLC
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94087
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Zhang
Phone
408-774-1832
Email
victor.zhang@curabio.com
First Name & Middle Initial & Last Name & Degree
Lizhen Wang, MD
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating the Safety and Efficacy of Cura-100 in Subjects With Rheumatoid Arthritis and Osteoarthritis
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