Rheumatoid ArthritisPhase 3NCT01351480
Benefits of Injectable Abatacept Using Magnetic Resonance Imaging (MRI) in Rheumatoid Arthritis (RA) Patients
A Phase 3 study testing abatacept in people with Rheumatoid Arthritis, run by Arthritis & Rheumatic Disease Specialties Research at 1 site in United States.
Trial summary
The purpose of this study is to determine if the use of sub-cutaneous (SC) abatacept provides any structural benefit in patients with rheumatoid arthritis who have failed prior use of TNF therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- abatacept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Apr 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able and willing to give written informed consent
- Patients must have a diagnosis of rheumatoid arthritis > 3 months
- Patients must have been receiving methotrexate for 12 weeks prior to screening at a dose of 10mg - 25 mg weekly.
- Patient must have had an inadequate response after receiving or previously receiving one (1) but no more than two (2) anti-TNF biologic agents
- Age >/= 18 yrs
- Must have active RA as defined by a DAS28 (Erythrocyte sedimentation rate) score >4.4
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- Must have synovitis of at least two joints in one hand/wrist at screening and baseline
- Must have a negative Pregnancy test and use adequate method of contraception throughout the trial
- Stable use of Corticosteroids is permitted
- Stable use of Non-steroidal anti-inflammatory drugs is permitted
Who cannot join
- Functional Class IV
- Pregnancy or breastfeeding
- History of any other inflammatory arthritis
- Sexually active patients who are not using acceptable birth control
- Subjects who have undergone metacarpophalangeal (MCP) arthroplasty or anticipate the need for such a procedure
- Subjects with a history of cancer in the last five years other than non melanoma skin cancers
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- Subjects who are unable to comply with study and followup procedures
- Subjects who have current or severe symptoms of renal, hepatic, hematologic, gastrointestinal, pulmonary cardiac, neurologic, or cerebral disease
- Subjects who currently abuse drugs or alcohol
- Subjects with evidence of active or latent bacterial or viral infections at the time of enrollment
- Subjects who have received live vaccines within 4 months of first dose of study medication
- Subjects with herpes zoster or cytomegalovirus that resolved less than two months prior to dosing
- Subjects at risk for tuberculosis (TB). Specifically excluded will be subjects with a history of active TB within the last 3 years and subjects with latent TB must have a negative chest X-ray and be started on treatment for at least 28 days prior to dosing.
- Prior treatment with Rituximab within 12 months
- Prior treatment with more than 2 TNFs
- Intramuscular(IM), Intravenous(IV) Intra-articular (IA) corticosteroids within 28 days prior to baseline
- Subjects who have a metal device affected by MRI (e.g. any type of electronic, mechanical or magnetic implant, metal slivers, metal objects, cardioverter defibrillator)
- Subjects who have received any disease modifying agent (DMARD) other than methotrexate within the past 28 days prior to baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthritis & Rheumatic Disease Specialties Research
Aventura, Florida, 33180
About this study
Official title: Assessment of Structural Benefits of Injectable Abatacept as Measured by MRI in RA Patients Who Have Failed Prior Anti-Tumor Necrosis (TNF) Therapy and Correlated With Clinical Outcomes
The purpose of this study is to determine if the use of sub-cutaneous (SC) abatacept provides any structural benefit in patients with rheumatoid arthritis who have failed prior use of TNF therapy.
Read the detailed description
Results in the literature suggest the structural benefits of intravenous (IV) abatacept as measured by high and low field MRI and X-ray in patients with rheumatoid arthritis who have previously failed clinical treatment with TNF agents. This study attempts to measure the structural benefits of SC abatacept in a similar cohort of patients while at the same time comparing the structural findings with clinical outcome measurements as collected at corresponding time points with an automated patient and physician disease activity scoring system of 28 joints (DAS28).
- Conditions
- Rheumatoid Arthritis
- Being tested
- abatacept
- Keywords
- Auto-immune Disease, Arthritis, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abataceptBiological
Also called orencia
Abatacept administered SC weekly at 125 mg dose
| Study group | Role | What they receive |
|---|---|---|
| abatacept | Other | open label use of abatacept for 12 months Receives: Biological: abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Improvement in Bone Edema/Osteitis on Low-field MRI in Rheumatoid Arthritis Patients on Weekly SC Abatacept in Combination With Methotrexate Over a 12-month Period.
bone edema/osteitis using low-field MRI analysis of 25 anatomical locations in the wrist and hand and scoring the volume of the original articular bone in 0.5 increments from 0-3, with each increment in the scale representing 33% of the volume of the peripheral 1 cm of original (eroded + residual) articular bone.
Measured: MRIs at Baseline and Week 48
Secondary outcomes (4)
Patients With an Improvement in DAS Score Were Considered Responders at Week 48
Patient with a positive change in DAS score were considered responders . The DAS score is calculated using the number of tender and swollen joints based upon a 28 joint count, the ESR in mm/hr., and the physician global score
Measured: The DAS 28 score will be performed at baseline and 48
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24
DAS 28> 5.1=high disease activity DAS28 <3.2=low disease activity DAS28 <2.6=remission Criteria used in formula are number of tender joints based upon 28 joints, number of swollen joints based on 28 joints, ESR in mm/hr and patient global health core based on 0-10 mm
Measured: Patient DAS 28 scores will be measured at baseline and weeks 12, 24, 48 and disease activity will be recorded at Week 48
the Clinical Outcomes Measurements (American College of Rheumatology Activity Scoring, Health Assessment The Number of Patients With a Clinical Response at Week 24 and 48
Patient with a positive change in DAS score were considered responders . The DAS score is calculated using the number of tender and swollen joints based upon a 28 joint count, the ESR in mm/hr., and the physician global score (1-10 cm). Total maximum score was at high disease activity at baseline.
Measured: week 24 and Week 48
Number of Patients With Adverse Events
site will report the number of patients with adverse envents from Day 1 up to 52 weeks
Measured: all adverse events will be captured from Day 1 up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthritis & Rheumatic Disease Specialties Research
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Norman B. Gaylis, MD, Arthritis & Rheumatic Disease Specialties Research
- Investigators
- Norman B Gaylis, MD, Principal investigator, Arthritis & Rheumatic Disease Specialties Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351480
- Sponsor's protocol ID
- IM101-306
- Status last verified
- Jan 2017
- First submitted
- 6 May 2011
- Last updated
- 13 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Structural Benefits of Injectable Abatacept as Measured by MRI in RA Patients Who Have Failed Prior Anti-Tumor Necrosis (TNF) Therapy and Correlated With Clinical Outcomes
- ClinicalTrials.gov ID
- NCT01351480
- Acronym / sponsor ID
- IM101-306
- Conditions
- Rheumatoid Arthritis
- Keywords
- Auto-immune Disease, Arthritis, Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Arthritis & Rheumatic Disease Specialties ResearchUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jun 2011 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 May 2011 (estimated)
- Results
- Posted 13 Mar 2017
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 if the use of sub-cutaneous (SC) abatacept provides any structural benefit in patients with rheumatoid arthritis who have failed prior use of TNF therapy.
Detailed description
Results in the literature suggest the structural benefits of intravenous (IV) abatacept as measured by high and low field MRI and X-ray in patients with rheumatoid arthritis who have previously failed clinical treatment with TNF agents. This study attempts to measure the structural benefits of SC abatacept in a similar cohort of patients while at the same time comparing the structural findings with clinical outcome measurements as collected at corresponding time points with an automated patient and physician disease activity scoring system of 28 joints (DAS28).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| abatacept | Other | Biological: abataceptopen label use of abatacept for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able and willing to give written informed consent
- Patients must have a diagnosis of rheumatoid arthritis > 3 months
- Patients must have been receiving methotrexate for 12 weeks prior to screening at a dose of 10mg - 25 mg weekly.
- Patient must have had an inadequate response after receiving or previously receiving one (1) but no more than two (2) anti-TNF biologic agents
- Age >/= 18 yrs
Key exclusion criteria (18 listed)
- Functional Class IV
- Pregnancy or breastfeeding
- History of any other inflammatory arthritis
- Sexually active patients who are not using acceptable birth control
- Subjects who have undergone metacarpophalangeal (MCP) arthroplasty or anticipate the need for such a procedure
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: orenciaAbatacept administered SC weekly at 125 mg dose | Biological | abatacept |
Primary outcome
Number of Participants With an Improvement in Bone Edema/Osteitis on Low-field MRI in Rheumatoid Arthritis Patients on Weekly SC Abatacept in Combination With Methotrexate Over a 12-month Period.
Time frame: MRIs at Baseline and Week 48
bone edema/osteitis using low-field MRI analysis of 25 anatomical locations in the wrist and hand and scoring the volume of the original articular bone in 0.5 increments from 0-3, with each increment in the scale representing 33% of the volume of the peripheral 1 cm of original (eroded + residual) articular bone.
4 secondary outcomes
Patients With an Improvement in DAS Score Were Considered Responders at Week 48
Time frame: The DAS 28 score will be performed at baseline and 48
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24
Time frame: Patient DAS 28 scores will be measured at baseline and weeks 12, 24, 48 and disease activity will be recorded at Week 48
the Clinical Outcomes Measurements (American College of Rheumatology Activity Scoring, Health Assessment The Number of Patients With a Clinical Response at Week 24 and 48
Time frame: week 24 and Week 48
Number of Patients With Adverse Events
Time frame: all adverse events will be captured from Day 1 up to 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Norman B Gaylis, MD principal investigator
Arthritis & Rheumatic Disease Specialties Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing abatacept in people with Rheumatoid Arthritis, run by Arthritis & Rheumatic Disease Specialties Research 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 18 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 Mar 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 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 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?
Yes. Results are posted in the registry (first posted 13 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With an Improvement in Bone Edema/Osteitis on Low-field MRI in Rheumatoid Arthritis Patients on Weekly SC Abatacept in Combination With Methotrexate Over a 12-month Period. (time frame: MRIs at Baseline and Week 48). 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 13 Mar 2017.