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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2007 by Cura Biotech LLC. Recruitment status was Not yet recruiting

First Received on March 30, 2007. Last Updated on February 18, 2009 History of Changes

Sponsor:	Cura Biotech LLC
Information provided by:	Cura Biotech LLC
ClinicalTrials.gov Identifier:	NCT00455208

Purpose

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

Condition	Intervention	Phase
Rheumatoid Arthritis Osteoarthritis	Drug: Cura-100	Phase I Phase II

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Cura Biotech LLC:

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.

Estimated Enrollment:	20
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2008

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.

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455208

Locations

United States, California
Cura Biotech LLC	Not yet recruiting
Sunnyvale, California, United States, 94087
Contact: Victor Zhang 408-774-1832 victor.zhang@curabio.com
Principal Investigator: Lizhen Wang, MD

Sponsors and Collaborators

Cura Biotech LLC

Investigators

Study Director:

Victor Zhang

Cura Biotech LLC

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00455208 History of Changes
Other Study ID Numbers:	CURA-07-10
Study First Received:	March 30, 2007
Last Updated:	February 18, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012