Rheumatoid ArthritisPhase 1NCT00162201
An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy
A Phase 1 study testing Abatacept in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 1 site in United Kingdom.
Trial summary
Study to assess changes in synovial tissue before and after treatment with Abatacept in subjects with RA who remained on their background disease modifying anti-arthritis medications but who have failed previous therapy with anti-TNF (tumor necrosing factor)blocking agents. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2003to Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RA for at least 1 year
- Clear clinical signs of active RA in 1 knee joint
- Meet ARA (1987) criteria for diagnosis of RA and ACR (1991) criteria for RA functional classes I, II, or III
- Inadequate clinical response to a minimum of 3 months of therapy with anti-TNF-blocking agents
- Taking background DMARDs for a minimum of 3 months and at stable doses for at least 28 days
Who cannot join
- Serious bacterial infection in last 3 months
- History of TB
- History of cancer within 5 years
- Evidence of latent or active bacterial or viral infection
- Intra-articular corticosteroids within 3 months
- Exposure to live vaccines
- Exposure to CTLA4Ig or BMS-188667
- Treatment with immunoadsorption column(s), mycophenolate mofetil, leflunomide, anakinra, cyclosporine, etanercept, adalimumab, infliximab, azathioprine, oral or parenteral gold, D-penacillamine, calcineurin inhibitors, cyclophosphamide or other alkylating agents
Trial locations and contacts
1 site in 1 country.
About this study
Study to assess changes in synovial tissue before and after treatment with Abatacept in subjects with RA who remained on their background disease modifying anti-arthritis medications but who have failed previous therapy with anti-TNF (tumor necrosing factor)blocking agents.
- 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
Also called Orencia
Parenteral, IV, 500 mg if < 60 kg; 750 mg if > 60 \& < 100 kg; 1000 mg if > 100 kg, Monthly, 4 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of each subject's synovial tissue markers
Measured: at baseline and after 4 months of treatment with abatacept
Secondary outcomes (2)
assess baseline & post treatment synovitis by dynamic gadolinium enhanced MRI; determine concentrations of abatacept in synovial fluid & serum
Measured: after 4 months of treatment
assess safety & tolerability of abatacept
Measured: administered for 4 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 2003
- Primary completionApr 2005
- Study completionApr 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
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
- NCT00162201
- Sponsor's protocol ID
- IM101-015
- Status last verified
- Apr 2011
- First submitted
- 9 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
Publications
Buch MH, Boyle DL, Rosengren S, Saleem B, Reece RJ, Rhodes LA, Radjenovic A, English A, Tang H, Vratsanos G, O'Connor P, Firestein GS, Emery P. Mode of action of abatacept in rheumatoid arthritis patients having failed tumour necrosis factor blockade: a histological, gene expression and dynamic magnetic resonance imaging pilot study. Ann Rheum Dis. 2009 Jul;68(7):1220-7. doi: 10.1136/ard.2008.091876. Epub 2008 Sep 4.
PubMed 18772191
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy
- ClinicalTrials.gov ID
- NCT00162201
- Acronym / sponsor ID
- IM101-015
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (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.
Study to assess changes in synovial tissue before and after treatment with Abatacept in subjects with RA who remained on their background disease modifying anti-arthritis medications but who have failed previous therapy with anti-TNF (tumor necrosing factor)blocking agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Abatacept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- RA for at least 1 year
- Clear clinical signs of active RA in 1 knee joint
- Meet ARA (1987) criteria for diagnosis of RA and ACR (1991) criteria for RA functional classes I, II, or III
- Inadequate clinical response to a minimum of 3 months of therapy with anti-TNF-blocking agents
- Taking background DMARDs for a minimum of 3 months and at stable doses for at least 28 days
Key exclusion criteria (8 listed)
- Serious bacterial infection in last 3 months
- History of TB
- History of cancer within 5 years
- Evidence of latent or active bacterial or viral infection
- Intra-articular corticosteroids within 3 months
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: OrenciaParenteral, IV, 500 mg if < 60 kg; 750 mg if > 60 \& < 100 kg; 1000 mg if > 100 kg, Monthly, 4 months. | Drug | 1 |
Primary outcome
Comparison of each subject's synovial tissue markers
Time frame: at baseline and after 4 months of treatment with abatacept
2 secondary outcomes
assess baseline & post treatment synovitis by dynamic gadolinium enhanced MRI; determine concentrations of abatacept in synovial fluid & serum
Time frame: after 4 months of treatment
assess safety & tolerability of abatacept
Time frame: administered for 4 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 12 Jan 2017.
- Background: PubMed 18772191Buch MH, Boyle DL, Rosengren S, Saleem B, Reece RJ, Rhodes LA, Radjenovic A, English A, Tang H, Vratsanos G, O'Connor P, Firestein GS, Emery P. Mode of action of abatacept in rheumatoid arthritis patients having failed tumour necrosis factor blockade: a histological, gene expression and dynamic magnetic resonance imaging pilot study. Ann Rheum Dis. 2009 Jul;68(7):1220-7. doi: 10.1136/ard.2008.091876. Epub 2008 Sep 4.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abatacept in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 1 site in United Kingdom.
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 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 12 Jan 2017. 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 Kingdom. 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?
Comparison of each subject's synovial tissue markers (time frame: at baseline and after 4 months of treatment with abatacept). 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 NCT00162201, 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 12 Jan 2017.