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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| abatacept | Other | open label use of abatacept for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abatacept | Biological | Abatacept administered SC weekly at 125 mg dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | MRIs at Baseline and Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The DAS 28 score will be performed at baseline and 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norman B Gaylis, MD | Arthritis & Rheumatic Disease Specialties Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthritis & Rheumatic Disease Specialties Research | Aventura | Florida | 33180 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Abatacept | open label use of abatacept for 12 months abatacept: Abatacept administered SC weekly at 125 mg dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Abatacept | open label use of abatacept for 12 months abatacept: Abatacept administered SC weekly at 125 mg dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | osteitis on the MRIs from 27 patients at baseline and week 48 | Posted | Number | participants | MRIs at Baseline and Week 48 |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abatacept | open label use of abatacept for 12 months abatacept: Abatacept administered SC weekly at 125 mg dose |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Norman B Gaylis, MD | AARDS Research, Inc. | 305-652-6676 | drnbg@rheum-care.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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| 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 | 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. | 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 | all adverse events will be captured from Day 1 up to 52 weeks |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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 | There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients | Posted | Number | participants | The DAS 28 score will be performed at baseline and 48 |
|
|
|
| Secondary | 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 | the number of participants who reached remission, low disease activity, moderate disease activity and high disease activity will be determined as based upon the DAS scale | Posted | Number | participants | Patient DAS 28 scores will be measured at baseline and weeks 12, 24, 48 and disease activity will be recorded at Week 48 |
|
|
|
| Secondary | 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. | There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients | Posted | Number | participants | week 24 and Week 48 |
|
|
|
| Secondary | Number of Patients With Adverse Events | site will report the number of patients with adverse envents from Day 1 up to 52 weeks | There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients | Posted | Number | participants | all adverse events will be captured from Day 1 up to 52 weeks |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| high disease activity at week 12 |
|
| clinical remission at week 24 |
|
| low disease activity at week 24 |
|
| moderate disease activity at week 24 |
|
| high disease activity at week 24 |
|
| clinical remission at week 48 |
|
| low disease activity at week 48 |
|
| moderate disease activity at week 48 |
|
| high disease activity at week 48 |
|