Rheumatoid ArthritisPhase 1/2NCT00455208
A Study Evaluating the Safety and Efficacy of Cura-100 in Subjects With Rheumatoid Arthritis and Osteoarthritis
A Phase 1/2 study testing Cura-100 in people with Rheumatoid Arthritis and Osteoarthritis, run by Cura Biotech LLC at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of Cura-100 in treating rheumatoid arthritis and osteoarthritis. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Osteoarthritis
- What is being tested?
- Cura-100
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Dec 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cura Biotech LLC
Sunnyvale, California, 94087
Victor Zhang, 408-774-1832, victor.zhang@curabio.com
Lizhen Wang, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis
- Being tested
- Cura-100
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cura-100Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2007 (estimated)
- Study startMay 2007
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cura Biotech LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Victor Zhang, Study director, Cura Biotech LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455208
- Sponsor's protocol ID
- CURA-07-10
- Status last verified
- Mar 2007
- First submitted
- 30 Mar 2007
- Last updated
- 19 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating Cura-100 in Rheumatoid Arthritis and Osteoarthritis
- ClinicalTrials.gov ID
- NCT00455208
- Acronym / sponsor ID
- CURA-07-10
- Conditions
- Rheumatoid Arthritis, Osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cura Biotech LLCIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Study completion
- Dec 2008 (estimated)
- First posted
- 3 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety and efficacy of Cura-100 in treating rheumatoid arthritis and osteoarthritis.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cura-100 | Drug | – |
Primary outcome
The primary outcome is remission of rheumatoid arthritis and osteoarthritis, which will be measured with ACR criteria.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Zhang study director
Cura Biotech LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cura-100 in people with Rheumatoid Arthritis and Osteoarthritis, run by Cura Biotech LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is remission of rheumatoid arthritis and osteoarthritis, which will be measured with ACR criteria.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2009.