Rheumatoid ArthritisPhase 2/3NCT01333878
Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage
A Phase 2/3 study testing Subcutaneous Abatacept in people with Rheumatoid Arthritis, run by Orrin M Troum, M.D. and Medical Associates at 1 site in United States.
Trial summary
The hypothesis of this study is that subcutaneous Abatacept is effective in reducing synovial inflammation, osteitis, and erosions in Rheumatoid Arthritis as assessed by low field extremity MRI and X-ray. 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?
- Subcutaneous Abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jan 2014
- Phase
- Phase 2/3
- 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
- Subjects currently experiencing active moderate to severe RA according to the revised 1987 ACR criteria for the diagnosis of RA at screening. The ESR-based DAS 28 must be equal or greater than 3.2
- MTX inadequate responders with moderate to severe RA. Subjects currently receiving MTX for at least 12 weeks and who have received MTX at a stable dose (≥15mg/week) for at least 6 weeks prior to treatment (Day 0). They must be biologic drug naive
- All subjects must receive at least 5 mg oral folic acid weekly.
- At screening active RA as defined by ≥ 6 swollen joints and ≥ 6 tender joints with erythrocyte sedimentation rate (ESR) ≥ 28 mm/h.
- Subjects must be seropositive with documented rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti CCP) positivity. If a documented history of RF or anti CCP positivity is not available, RF and anti CCP titers will be obtained at screening
- MRI evidence of at least one joint with osteitis or erosion attributable to RA as determined by an MRI musculoskeletal radiologist. Any joint of the dominant hand or wrist can be considered with the exception of distal interphalangeal joints of the hands.
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- If subjects are receiving an oral corticosteroid, the dose must be ≤10 mg/day prednisone (or equivalent) and stable for at least 28 days prior to treatment (Day 0).
- Subjects able and willing to give written informed consent and comply with the requirements of the study protocol. Informed consent must be obtained prior to any study-related procedures.
- A copy of the signed informed consent form must be given to the subject
- Subjects must be willing to self-inject or allow a caregiver to administer the subcutaneous injection
Who cannot join
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
- Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis or Felty's syndrome). Prior history of or current inflammatory joint disease other than RA (gout, Lyme disease, seronegative spondyloarthropathy including reactive arthritis and psoriatic arthritis)
- Functional class IV as defined by the ACR Classification of Functional Status in RA
- Current treatment with any traditional DMARDs other than MTX within 4 weeks before the screening visit
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening
- Exposure to any Biologic Response Modifying Agent
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- Intra Articular or parenteral corticosteroids within 6 weeks prior to screening
- Immunization with live vaccine within 3 months prior to enrollment and a need for a live vaccine during the study
- Subjects who have a metal device where the use of MRI is contraindicated (e.g.,any type of electronic, mechanical, or magnetic implant; cardiac pacemaker, aneurysm clip; implanted cardioverter defibrillator; or a cochlear implant). Subjects who have a potential ferromagnetic foreign body (metal shavings, metal slivers, other metal objects) for which they have sought medical attention
- Exclusionary laboratory: Serum creatinine >2 mg/dL, ALT or AST > 2.0 x ULN, total bilirubin > 2.0 x ULN, platelet count <100 x 109 /L, hemoglobin < 8.5 g/dL, WBC count < 1,000/mm3 , absolute neutrophil count < 1,000/ mm3, absolute lymphocyte count < 500/mm3, positive HBsAg or HCV antibody, or positive HIV test.
- Pregnant women or nursing mothers
- Females of child bearing potential who are not using reliable means of contraception
- Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine or GI disease
- Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel syndrome, where flares are commonly treated with corticosteroids
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections such as atypical mycobacterial disease, hepatitis B and C, HIV, herpes zoster, or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
- A history of active TB within the last 3 years even if it was treated. A history of active TB greater than 3 years ago unless there is documentation that the prior anti-TB treatment was appropriate in duration and type. A positive PPD skin test (≥5 mm) or positive QuantiFERON-TB Gold serum test without appropriate prophylaxis (at least 1 month of the planned local guidelines treatment regimen)
- Any malignancy except for skin cancer (basal cell or squamous cell) diagnosed within the previous 5 years
- History of alcohol, drug, or chemical abuse
- Neuropathies or other painful conditions that might interfere with pain evaluation
Trial locations and contacts
1 site in 1 country.
United States1 site
Orrin M. Troum, MD and Medical Associates
Santa Monica, California, 90404
About this study
Official title: An Open-Label, Pilot Trial to Assess the Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage Determined by Low Field Extremity MRI (eMRI) and X-ray
The hypothesis of this study is that subcutaneous Abatacept is effective in reducing synovial inflammation, osteitis, and erosions in Rheumatoid Arthritis as assessed by low field extremity MRI and X-ray.
Read the detailed description
This is an open-label study of the efficacy of subcutaneous (SC) Abatacept to inhibit progression of structural joint damage in patients with active rheumatoid arthritis (RA) receiving MTX and have inadequate disease control (defined as an ESR based DAS28 ≥ 3.2 AND ≥ 6 swollen and ≥ 6 tender joints). The study consists of a screening period (Days -21 to -7), a baseline visit (Days -20 to -1), and a treatment Period (open label Abatacept 125 mg SC for 24 weeks). All the visits may occur at the indicated week +/- 2 days. The last efficacy assessments are to be conducted at Week 24 and subjects are to be contacted by telephone for a safety follow-up 2 months after the final study agent has been administered.
The maximum length of the study is 35 weeks, which includes the 2-week screening period, 1-week baseline period, 24-week open label treatment, and 8-week follow-up period. Eligible subjects are to continue their current MTX treatment regimen, a stable dose of at least 15mg/week, during the entire length of the study (24 weeks). At Day 0, patients who meet inclusion criteria, will be dosed from Day 0 to Week 24 with Abatacept 125 mg SC injection.
Subjects are to self-administer SC study agent at Weeks 5, 6, 7, 9, 10, 11, 13, 14, 15, 17, 18, 19, 21, 22, and 23 and are not required to return to the study site at these weeks. All other visits, SC study agent is to be administered while the subject is at the study site.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Subcutaneous 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.
Subcutaneous AbataceptBiological
Subcutaneous Abatacept 125 mg once weekly for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Subcutaneous Abatacept | Experimental | Open-Label Subcutaneous Abatacept Receives: Biological: Subcutaneous Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition & progression of structural damage
Assess inhibition \& progression of structural damage in MTX inadequate responders with moderate to severe active RA on SC Abatacept plus MTX, utilizing eMRI and X-ray at baseline, eMRI at Week 12, and eMRI and X-ray final assessment at week 24.
Measured: 6 months
Secondary outcomes (1)
Improvement in ESR-based DAS28
Assess improvement in ESR-based DAS28, physician global assessment, and improvement in HAQ score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2013
- Study completionJan 2014
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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orrin M Troum, M.D. and Medical Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Orrin M Troum, MD, Principal investigator, Orrin M. Troum, MD & Medical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333878
- Sponsor's protocol ID
- BMS IM101-281
- Status last verified
- Apr 2014
- First submitted
- 7 Apr 2011
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Pilot Trial to Assess the Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage Determined by Low Field Extremity MRI (eMRI) and X-ray
- ClinicalTrials.gov ID
- NCT01333878
- Acronym / sponsor ID
- BMS IM101-281
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Orrin M Troum, M.D. and Medical AssociatesUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Mar 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 12 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 hypothesis of this study is that subcutaneous Abatacept is effective in reducing synovial inflammation, osteitis, and erosions in Rheumatoid Arthritis as assessed by low field extremity MRI and X-ray.
Detailed description
This is an open-label study of the efficacy of subcutaneous (SC) Abatacept to inhibit progression of structural joint damage in patients with active rheumatoid arthritis (RA) receiving MTX and have inadequate disease control (defined as an ESR based DAS28 ≥ 3.2 AND ≥ 6 swollen and ≥ 6 tender joints). The study consists of a screening period (Days -21 to -7), a baseline visit (Days -20 to -1), and a treatment Period (open label Abatacept 125 mg SC for 24 weeks). All the visits may occur at the indicated week +/- 2 days. The last efficacy assessments are to be conducted at Week 24 and subjects are to be contacted by telephone for a safety follow-up 2 months after the final study agent has been administered.
The maximum length of the study is 35 weeks, which includes the 2-week screening period, 1-week baseline period, 24-week open label treatment, and 8-week follow-up period. Eligible subjects are to continue their current MTX treatment regimen, a stable dose of at least 15mg/week, during the entire length of the study (24 weeks). At Day 0, patients who meet inclusion criteria, will be dosed from Day 0 to Week 24 with Abatacept 125 mg SC injection.
Subjects are to self-administer SC study agent at Weeks 5, 6, 7, 9, 10, 11, 13, 14, 15, 17, 18, 19, 21, 22, and 23 and are not required to return to the study site at these weeks. All other visits, SC study agent is to be administered while the subject is at the study site.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label Subcutaneous Abatacept | Experimental | Biological: Subcutaneous AbataceptOpen-Label Subcutaneous Abatacept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects currently experiencing active moderate to severe RA according to the revised 1987 ACR criteria for the diagnosis of RA at screening. The ESR-based DAS 28 must be equal or greater than 3.2
- MTX inadequate responders with moderate to severe RA. Subjects currently receiving MTX for at least 12 weeks and who have received MTX at a stable dose (≥15mg/week) for at least 6 weeks prior to treatment (Day 0). They must be biologic drug naive
- All subjects must receive at least 5 mg oral folic acid weekly.
- At screening active RA as defined by ≥ 6 swollen joints and ≥ 6 tender joints with erythrocyte sedimentation rate (ESR) ≥ 28 mm/h.
- Subjects must be seropositive with documented rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti CCP) positivity. If a documented history of RF or anti CCP positivity is not available, RF and anti CCP titers will be obtained at screening
Key exclusion criteria (19 listed)
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
- Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis or Felty's syndrome). Prior history of or current inflammatory joint disease other than RA (gout, Lyme disease, seronegative spondyloarthropathy including reactive arthritis and psoriatic arthritis)
- Functional class IV as defined by the ACR Classification of Functional Status in RA
- Current treatment with any traditional DMARDs other than MTX within 4 weeks before the screening visit
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening
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 |
|---|---|---|
| Subcutaneous AbataceptSubcutaneous Abatacept 125 mg once weekly for 6 months | Biological | Open-Label Subcutaneous Abatacept |
Primary outcome
Inhibition & progression of structural damage
Time frame: 6 months
Assess inhibition \& progression of structural damage in MTX inadequate responders with moderate to severe active RA on SC Abatacept plus MTX, utilizing eMRI and X-ray at baseline, eMRI at Week 12, and eMRI and X-ray final assessment at week 24.
1 secondary outcome
Improvement in ESR-based DAS28
Time frame: 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 17 Apr 2014.
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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.
Orrin M Troum, MD principal investigator
Orrin M. Troum, MD & Medical Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Subcutaneous Abatacept in people with Rheumatoid Arthritis, run by Orrin M Troum, M.D. and Medical Associates at 1 site 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 10 inclusion and 19 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 17 Apr 2014. 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 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Inhibition & progression of structural damage (time frame: 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 17 Apr 2014.