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

March 30, 2007
February 18, 2009
May 2007
Not Provided
The primary outcome is remission of rheumatoid arthritis and osteoarthritis, which will be measured with ACR criteria.
Same as current
Complete list of historical versions of study NCT00455208 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
A Study Evaluating the Safety and Efficacy of Cura-100 in Subjects With Rheumatoid Arthritis and Osteoarthritis
Study Evaluating Cura-100 in Rheumatoid Arthritis and Osteoarthritis

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

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Rheumatoid Arthritis
  • Osteoarthritis
Drug: Cura-100
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
December 2008
Not Provided

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
Both
20 Years to 50 Years
Yes
United States
 
NCT00455208
CURA-07-10
Yes
Not Provided
Cura Biotech LLC
Not Provided
Study Director: Victor Zhang Cura Biotech LLC
Cura Biotech LLC
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP