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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
Sponsor:
Information provided by:
Cura Biotech LLC
ClinicalTrials.gov Identifier:
NCT00455208
First received: March 30, 2007
Last updated: February 18, 2009
Last verified: March 2007
History of Changes
  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 1
Phase 2

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:

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 May 16, 2013