Rheumatoid ArthritisPhase 1NCT00279734
Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers
A Phase 1 study testing Tetanus + pnemococcal vaccines alone and Abatacept + vaccines in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
Study to assess the ability of healthy subjects to build anitbodies to tetanus and pneumococcal vaccines after receiving a single intravenous dose of Abatacept, a drug which is being developed for the treatment of Rheumatoid Arthritis and which can affect the immune system. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tetanus + pnemococcal vaccines alone and Abatacept + vaccines
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2004to Jan 2005
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Subjects
- Body Weight between 60 and 100 kg.
- Males and Females must be using adequate contraceptive methods during study and for 10 weeks after dose of study mediciation.
Who cannot join
- Females who are prgnant or breastfeeding
- History of autoimmune disorder, immunodeficiency, or infection within past 3 months.
- Active TB requiring treatment within the previous 3 years.
- Positive breast cancer screen, PPD test.
- Vaccination with tetanus or pneumococcal vaccine within 5 years.
- Vaccination with any live vaccine within 4 weeks.
- History of drug or alcohol abuse.
- Any significant allergy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
PPD Development
Austin, Texas
Parexel International Corp
Baltimore, Maryland
Qutintiles Phase I Services
Lenexa, Kansas
About this study
Official title: An Exploratory Study to Evaluate the Effect of Abatacept (BMS-188667) on the Antibody Response Following Tetanus Toxoid and 23-Valent Pneumococcal Vaccinations in Healthy Subjects
Study to assess the ability of healthy subjects to build anitbodies to tetanus and pneumococcal vaccines after receiving a single intravenous dose of Abatacept, a drug which is being developed for the treatment of Rheumatoid Arthritis and which can affect the immune system.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tetanus + pnemococcal vaccines alone, Abatacept + vaccines
- Keywords
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus + pnemococcal vaccines aloneDrug
0 mg + vaccines, Single dose, 28 days.
Abatacept + vaccinesDrug
Also called Orencia
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days.
Abatacept + vaccinesDrug
Also called Orencia
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 56 days.
Abatacept + VaccinesDrug
Also called Orencia
parenteral, IV, 750 mg abatacept + vaccines, Single dose, 84 days.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Drug: Tetanus + pnemococcal vaccines alone |
| Group 2 | Active comparator | Not described Receives: Drug: Abatacept + vaccines |
| Group 3 | Active comparator | Not described Receives: Drug: Abatacept + vaccines |
| Group 4 | Active comparator | Not described Receives: Drug: Abatacept + Vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines.
Secondary outcomes (1)
Assess safety and tolerability of Abatacept given in conjunction with tetanus toxoid and 23-valent pneumococcal vaccines.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2006 (estimated)
- Study startAug 2004
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279734
- Sponsor's protocol ID
- IM101-049
- Status last verified
- Apr 2011
- First submitted
- 19 Jan 2006
- Last updated
- 13 Apr 2011
- Results posted
- No
Publications
Tay L, Leon F, Vratsanos G, Raymond R, Corbo M. Vaccination response to tetanus toxoid and 23-valent pneumococcal vaccines following administration of a single dose of abatacept: a randomized, open-label, parallel group study in healthy subjects. Arthritis Res Ther. 2007;9(2):R38. doi: 10.1186/ar2174.
PubMed 17425783
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate the Effect of Abatacept (BMS-188667) on the Antibody Response Following Tetanus Toxoid and 23-Valent Pneumococcal Vaccinations in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00279734
- Acronym / sponsor ID
- IM101-049
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 20 Jan 2006 (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.
Study to assess the ability of healthy subjects to build anitbodies to tetanus and pneumococcal vaccines after receiving a single intravenous dose of Abatacept, a drug which is being developed for the treatment of Rheumatoid Arthritis and which can affect the immune system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Tetanus + pnemococcal vaccines alone |
| Group 2 | Active comparator | Drug: Abatacept + vaccines |
| Group 3 | Active comparator | Drug: Abatacept + vaccines |
| Group 4 | Active comparator | Drug: Abatacept + Vaccines |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy Subjects
- Body Weight between 60 and 100 kg.
- Males and Females must be using adequate contraceptive methods during study and for 10 weeks after dose of study mediciation.
Key exclusion criteria (8 listed)
- Females who are prgnant or breastfeeding
- History of autoimmune disorder, immunodeficiency, or infection within past 3 months.
- Active TB requiring treatment within the previous 3 years.
- Positive breast cancer screen, PPD test.
- Vaccination with tetanus or pneumococcal vaccine within 5 years.
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 |
|---|---|---|
| Tetanus + pnemococcal vaccines alone0 mg + vaccines, Single dose, 28 days. | Drug | Group 1 |
| Abatacept + vaccinesAlso: OrenciaParenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days. | Drug | Group 2 |
| Abatacept + vaccinesAlso: OrenciaParenteral, IV, 750 mg abatacept + vaccines, Single dose, 56 days. | Drug | Group 3 |
| Abatacept + VaccinesAlso: Orenciaparenteral, IV, 750 mg abatacept + vaccines, Single dose, 84 days. | Drug | Group 4 |
Primary outcome
Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines.
1 secondary outcome
Assess safety and tolerability of Abatacept given in conjunction with tetanus toxoid and 23-valent pneumococcal vaccines.
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 13 Apr 2011.
- Derived from this study: PubMed 17425783Tay L, Leon F, Vratsanos G, Raymond R, Corbo M. Vaccination response to tetanus toxoid and 23-valent pneumococcal vaccines following administration of a single dose of abatacept: a randomized, open-label, parallel group study in healthy subjects. Arthritis Res Ther. 2007;9(2):R38. doi: 10.1186/ar2174.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tetanus + pnemococcal vaccines alone and Abatacept + vaccines in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 3 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 3 inclusion and 8 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 13 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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.
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?
Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00279734, which also lists 1 linked publication.
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 13 Apr 2011.