NCT00455208

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started May 2007

Typical duration for phase_1 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2007

Completed
28 days until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 19, 2009

Status Verified

March 1, 2007

First QC Date

March 30, 2007

Last Update Submit

February 18, 2009

Conditions

Rheumatoid ArthritisOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is remission of rheumatoid arthritis and osteoarthritis, which will be measured with ACR criteria.

Secondary Outcomes (1)

  • 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.

Interventions

Cura-100DRUG

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cura Biotech LLC

Sunnyvale, California, 94087, United States

Location

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Victor Zhang

    Cura Biotech LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 30, 2007

First Posted

April 3, 2007

Study Start

May 1, 2007

Study Completion

December 1, 2008

Last Updated

February 19, 2009

Record last verified: 2007-03

Locations

US(1)