Rheumatoid ArthritisPhase 2NCT00162279
The Study of Abatacept in Combination With Etanercept
A Phase 2 study testing Abatacept in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 35 sites in United States.
Trial summary
The Study was designed to look at the safety and efficacy of abatacept in combination with etanercept. 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
- How many people
- 141 participants
- Where
- 35 sitesUnited States
- Study dates
- Oct 2000to Feb 2007
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects who had completed the short term portion of IM101-101.
Who cannot join
None listed.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Local Institution
Albany, New York
Local Institution
Austin, Texas
Local Institution
Bismarck, North Dakota
Local Institution
Boston, Massachusetts
Local Institution
Charleston, South Carolina
Local Institution
Chicago, Illinois
Local Institution
Cincinnati, Ohio
Local Institution
Dallas, Texas
Local Institution
Denver, Colorado
Local Institution
Duluth, Minnesota
Local Institution
Duncansville, Pennsylvania
Local Institution
Edmonds, Washington
Local Institution
Fort Lauderdale, Florida
Local Institution
Glendale, Wisconsin
Local Institution
Hagerstown, Maryland
Local Institution
Huntsville, Alabama
Local Institution
Knoxville, Tennessee
Local Institution
La Jolla, California
Local Institution
Lincoln, Nebraska
Local Institution
Long Beach, California
Local Institution
Los Alamos, New Mexico
Local Institution
Los Angeles, California
Local Institution
Mineola, New York
Local Institution
New Brunswick, New Jersey
Local Institution
New York, New York
Local Institution
Norristown, Pennsylvania
Local Institution
Palo Alto, California
Local Institution
Portland, Oregon
Local Institution
Rome, Georgia
Local Institution
Salt Lake City, Utah
Local Institution
San Francisco, California
Local Institution
Springfield, Massachusetts
Local Institution
Tacoma, Washington
Local Institution
Temple, Texas
Local Institution
Titusville, Florida
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Intravenous Infusions of BMS-188667 (10 mg/kg) Given Monthly in Combination With Subcutaneous Injections of Etanercept (25mg)Given Twice Weekly to Subjects With Active Rheumatoid Arthritis
The Study was designed to look at the safety and efficacy of abatacept in combination with etanercept.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Abatacept
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Abatacept combined with etanercept will have greater clinical efficacy compared to subjects receiving etanercept alone
Measured: at 6 months
Secondary outcomes (1)
ACR 50 and 70 will be evaluated
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startOct 2000
- Primary completionFeb 2007
- Study completionFeb 2007
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.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 141 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162279
- Sponsor's protocol ID
- IM101-101
- Status last verified
- Dec 2010
- First submitted
- 9 Sep 2005
- Last updated
- 6 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Intravenous Infusions of BMS-188667 (10 mg/kg) Given Monthly in Combination With Subcutaneous Injections of Etanercept (25mg)Given Twice Weekly to Subjects With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00162279
- Acronym / sponsor ID
- IM101-101
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2000
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 13 Sep 2005 (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 Study was designed to look at the safety and efficacy of abatacept in combination with etanercept.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All subjects who had completed the short term portion of IM101-101.
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 |
|---|---|---|
| Abatacept | Drug | – |
Primary outcome
Abatacept combined with etanercept will have greater clinical efficacy compared to subjects receiving etanercept alone
Time frame: at 6 months
1 secondary outcome
ACR 50 and 70 will be evaluated
Time frame: at 6 months
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 6 Dec 2010.
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R-2487 in Patients With Sjogren's Syndrome (SjD)
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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.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abatacept in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 35 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 1 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 6 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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.
What does this phase mean?
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?
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?
Abatacept combined with etanercept will have greater clinical efficacy compared to subjects receiving etanercept alone (time frame: at 6 months). 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 6 Dec 2010.