A Study Evaluating the Safety and Efficacy of Cura-100 in Subjects With Rheumatoid Arthritis and Osteoarthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Study Evaluating Cura-100 in Rheumatoid Arthritis and Osteoarthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00455208
• Other study ID #: CURA-07-10
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: March 30, 2007
• Last updated: February 18, 2009
• Start date: May 2007
• Est. completion date: December 2008

Study information

• Verified date: March 2007
• Source: Cura Biotech LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and efficacy of Cura-100 in treating rheumatoid arthritis and osteoarthritis.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Drug:
• Cura-100

Locations

Country	Name	City	State
United States	Cura Biotech LLC	Sunnyvale	California

Sponsors (1)

Lead Sponsor	Collaborator
Cura Biotech LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is remission of rheumatoid arthritis and osteoarthritis, which will be measured with ACR criteria.
Secondary	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.