Rheumatoid ArthritisNCT01339481
A Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept
An observational study of Rheumatoid Arthritis, run by Astellas Pharma Inc at 7 sites in United States.
Trial summary
The purpose of this study is to characterize CD86 receptor occupancy in subjects with rheumatoid arthritis (RA) receiving abatacept. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- abatacept
- Type of treatment
- Injection or infusion
- How many people
- 26 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2011to Oct 2011
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with Rheumatoid Arthritis
Who may be able to join
- Subject has rheumatoid arthritis (RA), is both abatacept- and belatacept-naïve, and is an eligible candidate to start a course of treatment with abatacept in accordance with the product label
- Subject is willing and able to comply with study visits and procedures
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Metroplex Clinical Research Center
Dallas, Texas, 75231
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
North Shore - Long Island Jewish Health System
Lake Success, New York, 11042
Low County Rheumatology
North Charleston, South Carolina, 29406
Arthritis Research of Florida
Palm Harbor, Florida, 34684
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
About this study
Official title: A Phase 0, Open-Label, Multi-Center, Observational Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept
The purpose of this study is to characterize CD86 receptor occupancy in subjects with rheumatoid arthritis (RA) receiving abatacept.
- Conditions
- Rheumatoid Arthritis
- Being tested
- abatacept
- Keywords
- Orencia, Abatacept, Rheumatoid Arthritis, Infusion
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abataceptDrug
Also called Orencia
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| Subjects with RA initiating abatacept treatment regimen | Subjects naïve to both abatacept and belatacept Receives: Drug: abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD86 Receptor Occupancy
Measured: Day 1, Weeks 2, 4, 8, and 12
Secondary outcomes (5)
CD80 Receptor Occupancy
Measured: Day 1, Weeks 2, 4, 8, and 12
Abatacept serum concentration
Measured: Day 1, Weeks 2, 4, 8 and 12
Change from Day 1 to Week 12 in Subject's Global Assessment of Arthritis
Measured: Day 1 and Week 12
Change from Day 1 to Week 12 in Physician's Global Assessment of Arthritis
Measured: Day 1 and Week 12
Safety assessed by adverse event reporting including Physical Examination findings
Measured: Day 1 through Week 12 post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2011
- Study completionOct 2011
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Perseid Therapeutics LLC
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global DevelopmentPrincipal Investigator, Principal investigator, Metroplex Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339481
- Sponsor's protocol ID
- 2408-CL-0103
- Status last verified
- Nov 2011
- First submitted
- 13 Apr 2011
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0, Open-Label, Multi-Center, Observational Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept
- ClinicalTrials.gov ID
- NCT01339481
- Acronym / sponsor ID
- 2408-CL-0103
- Conditions
- Rheumatoid Arthritis
- Keywords
- Orencia, Abatacept, Rheumatoid Arthritis, Infusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Perseid Therapeutics LLC
- Study start
- Feb 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 20 Apr 2011 (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 this study is to characterize CD86 receptor occupancy in subjects with rheumatoid arthritis (RA) receiving abatacept.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with RA initiating abatacept treatment regimen | – | Drug: abataceptSubjects naïve to both abatacept and belatacept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with Rheumatoid Arthritis
Key inclusion criteria (2 listed)
- Subject has rheumatoid arthritis (RA), is both abatacept- and belatacept-naïve, and is an eligible candidate to start a course of treatment with abatacept in accordance with the product label
- Subject is willing and able to comply with study visits and procedures
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| abataceptAlso: OrenciaIntravenous Infusion | Drug | Subjects with RA initiating abatacept treatment regimen |
Primary outcome
CD86 Receptor Occupancy
Time frame: Day 1, Weeks 2, 4, 8, and 12
5 secondary outcomes
CD80 Receptor Occupancy
Time frame: Day 1, Weeks 2, 4, 8, and 12
Abatacept serum concentration
Time frame: Day 1, Weeks 2, 4, 8 and 12
Change from Day 1 to Week 12 in Subject's Global Assessment of Arthritis
Time frame: Day 1 and Week 12
Change from Day 1 to Week 12 in Physician's Global Assessment of Arthritis
Time frame: Day 1 and Week 12
Safety assessed by adverse event reporting including Physical Examination findings
Time frame: Day 1 through Week 12 post-infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2011.
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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.
Medical Director study director
Astellas Pharma Global Development
Principal Investigator principal investigator
Metroplex Clinical Research Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Astellas Pharma Inc at 7 sites 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 2 inclusion and 0 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: finished, as of the sponsor's last update on 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD86 Receptor Occupancy (time frame: Day 1, Weeks 2, 4, 8, and 12). 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 29 Nov 2011.