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

This study is not yet open for participant recruitment.
Verified by Cura Biotech LLC, March 2007

Sponsored by: 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

MedlinePlus related topics:   Osteoarthritis    Rheumatoid Arthritis   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:   Study Evaluating Cura-100 in Rheumatoid Arthritis and Osteoarthritis

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    
      Sunnyvale, California, United States, 94087

Sponsors and Collaborators
Cura Biotech LLC

Investigators
Study Director:     Victor Zhang     Cura Biotech LLC    
  More Information


Introduction to the study of Cura-100  This link exits the ClinicalTrials.gov site
 

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

Study placed in the following topic categories:
Autoimmune Diseases
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on October 22, 2008




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