Multiple SclerosisPhase 2NCT00035529
A Study to Evaluate the Preliminary Efficacy Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-remitting Multiple Sclerosis
A Phase 2 study testing BMS 188667 (Abatacept) in people with Multiple Sclerosis, run by Bristol-Myers Squibb at 10 sites in United States.
Trial summary
The purpose of this study is to determine whether BMS-188667 will decrease multiple sclerosis disease activity on MRI examinations, as well as decrease the rate of clinical MS exacerbations, compared to placebo Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- BMS 188667 (Abatacept)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 10 sitesUnited States
- Study dates
- Nov 2001to Dec 2003
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- relapsing-remitting MS
- at least 1 exacerbation in preceding 2 years
- at least 1 MRI lesion
- stable for 2 months prior to dosing
Who cannot join
- progressive MS
- currently treated with an immunomodulatory therapy
- previously treated with an approved MS drug where treatment was discontinued for lack of efficacy
- active bacterial or viral infections
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Local Institution
Burlington, Vermont
Local Institution
Charlotte, North Carolina
Local Institution
Dallas, Texas
Local Institution
Louisville, Kentucky
Local Institution
Madison, Wisconsin
Local Institution
New Haven, Connecticut
Local Institution
New York, New York
Local Institution
Newark, New Jersey
Local Institution
Philadelphia, Pennsylvania
Local Institution
Worcester, Massachusetts
About this study
Official title: A Phase II,Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Preliminary Efficacy, Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-Remitting Multiple Sclerosis
The purpose of this study is to determine whether BMS-188667 will decrease multiple sclerosis disease activity on MRI examinations, as well as decrease the rate of clinical MS exacerbations, compared to placebo
- Conditions
- Multiple Sclerosis
- Being tested
- Placebo, BMS 188667 (Abatacept)
- Keywords
- MS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Solution, i.v infusion, 0 mg, Days 1 \& 15 then monthly, 10 months.
BMS 188667 (Abatacept)Drug
Also called Orencia
Vial, i.v infusion, 2mg/kg, Days 1 \& 15 then monthly, 10 months.
BMS 188667 (Abatacept)Drug
Also called Orencia
Vial, i.v infusion, 10 mg/kg, Days 1 \& 15 then monthly, 10 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Drug: Placebo |
| 2 | Active comparator | Not described Receives: Drug: BMS 188667 (Abatacept) |
| 3 | Active comparator | Not described Receives: Drug: BMS 188667 (Abatacept) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preliminary efficacy- Reduction in cumulative nr of new or recurrent Gd-enhancing lesions.
Secondary outcomes (1)
Preliminary efficacy: 1) Decrease in annualized relapse rate and 2) Reduction in cumulative nr of new or enlarging T2-weighted MRI lesions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2002 (estimated)
- Study startNov 2001
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035529
- Sponsor's protocol ID
- IM101-200
- Status last verified
- Dec 2010
- First submitted
- 3 May 2002
- 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 Phase II,Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Preliminary Efficacy, Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00035529
- Acronym / sponsor ID
- IM101-200
- Conditions
- Multiple Sclerosis
- Keywords
- MS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 6 May 2002 (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 determine whether BMS-188667 will decrease multiple sclerosis disease activity on MRI examinations, as well as decrease the rate of clinical MS exacerbations, compared to placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Placebo |
| 2 | Active comparator | Drug: BMS 188667 (Abatacept) |
| 3 | Active comparator | Drug: BMS 188667 (Abatacept) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- relapsing-remitting MS
- at least 1 exacerbation in preceding 2 years
- at least 1 MRI lesion
- stable for 2 months prior to dosing
Key exclusion criteria (4 listed)
- progressive MS
- currently treated with an immunomodulatory therapy
- previously treated with an approved MS drug where treatment was discontinued for lack of efficacy
- active bacterial or viral infections
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 |
|---|---|---|
| PlaceboSolution, i.v infusion, 0 mg, Days 1 \& 15 then monthly, 10 months. | Drug | 1 |
| BMS 188667 (Abatacept)Also: OrenciaVial, i.v infusion, 2mg/kg, Days 1 \& 15 then monthly, 10 months. | Drug | 2 |
| BMS 188667 (Abatacept)Also: OrenciaVial, i.v infusion, 10 mg/kg, Days 1 \& 15 then monthly, 10 months. | Drug | 3 |
Primary outcome
Preliminary efficacy- Reduction in cumulative nr of new or recurrent Gd-enhancing lesions.
1 secondary outcome
Preliminary efficacy: 1) Decrease in annualized relapse rate and 2) Reduction in cumulative nr of new or enlarging T2-weighted MRI lesions.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2010.
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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.
10 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 BMS 188667 (Abatacept) in people with Multiple Sclerosis, run by Bristol-Myers Squibb at 10 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 4 inclusion and 4 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: stopped early, 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 10 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 was stopped early. Results are not available in the source record.
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?
Preliminary efficacy- Reduction in cumulative nr of new or recurrent Gd-enhancing lesions.. 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.