Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate if baseline levels of T cell associated biomarkers predict efficacy of abatacept during 24 weeks of treatment in patients with moderate to severe active Rheumatoid Arthritis (RA) who have had an inadequate response to conventional disease modifying anti-rheumatic drugs (cDMARDs)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abatacept | Experimental | Abatacept 125mg subcutaneous injection weekly for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug | All the subjects will receive Abatacept subcutaneous injection once a week for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With American College of Rheumatology (ACR) 20 Response at Week 14 | Baseline levels of T cell-associated biomarkers predict ACR20 response (improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept | 14 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With American College of Rheumatology (ACR) 20 Response at Week 24 | Baseline levels of T cell associated biomarkers predict ACR20 response (improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Previous treatment with Abatacept (Orencia)
Previous treatment with rituximab, tocilizumab, tofacitinib, sarilumab, or anakinra
Previous treatment with IV immunoglobulin, plasmapheresis, or alkylating agents such as cyclophosphamide
Intraarticular or parenteral corticosteroids within 4 weeks of screening
Rheumatic autoimmune disease other than Rheumatoid Arthritis, including Systemic Lupus Erythematosus, primary Sjogren syndrome, spondyloarthritis, systemic sclerosis, dermatomyositis, mixed connective tissue disease, or vasculitis
Non-rheumatic auto-immune disease including inflammatory bowel disease, psoriasis, multiple sclerosis
Recurrent or chronic bacterial, viral, fungal, mycobacterial, or other infections including Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C, latent tuberculosis (TB) (TB not adequately treated)
Primary or secondary immunodeficiency
Current, uncontrolled renal, gastrointestinal, endocrine, pulmonary, cardiac, or neurologic disease
History of malignancy within 10 years prior to screening, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma
History of alcohol, drug, or chemical abuse within 1 year prior to screening
Laboratory exclusion criteria at screening including:
Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery during the study
Immunization with a live/attenuated vaccine within 4 weeks prior to screening
Pregnant or nursing women, or women of child bearing potential who plan to become pregnant prior to 14 weeks after the last dose of abatacept treatment
Patients of reproductive potential not willing to use an effective method of contraception
Prisoners, or subjects who are compulsory detained
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kwanghoon Han, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Abatacept | Subjects will receive abatacept 125mg subcutaneous injection once a week for 24 doses (24 weeks) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Abatacept | Subjects will receive abatacept 125mg subcutaneous injection once a week for 24 doses (24 weeks) |
| 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 American College of Rheumatology (ACR) 20 Response at Week 14 | Baseline levels of T cell-associated biomarkers predict ACR20 response (improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept | Posted | Number | participants | 14 Weeks |
|
|
From time of study drug administration to end of study (week 24 or safety follow-up visit, if needed), up to 39 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abatacept | Subjects will receive abatacept 125mg subcutaneous injection once a week for 24 doses (24 weeks) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| upper respiratory infection | Infections and infestations | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bobby Kwanghoon Han | University of Washington | 206-685-9950 | hank4@uw.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2018 | Jul 9, 2024 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 24 Weeks |
| Number of Participants With American College of Rheumatology (ACR) 50 Response at Week 24 | Baseline levels of T cell associated biomarkers predict ACR50 response (improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept | Week 24 |
| Number of Participants With American College of Rheumatology (ACR) 70 Response at Week 24 | Baseline levels of T cell associated biomarkers predict ACR70 response (improvement of 70% in the number of tender and number of swollen joints, and a 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept | Week 24 |
| Number of Participants With European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24 | Baseline levels of T cell associated biomarkers predict EULAR good or moderate response (disease activity index for RA generated from tender and swollen joint count, patient global assessment, ESR or C-reactive protein) with subcutaneous abatacept | Week 24 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Number of Participants With American College of Rheumatology (ACR) 20 Response at Week 24 | Baseline levels of T cell associated biomarkers predict ACR20 response (improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept | Posted | Number | participants | 24 Weeks |
|
|
|
| Secondary | Number of Participants With American College of Rheumatology (ACR) 50 Response at Week 24 | Baseline levels of T cell associated biomarkers predict ACR50 response (improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept | Posted | Number | participants | Week 24 |
|
|
|
| Secondary | Number of Participants With American College of Rheumatology (ACR) 70 Response at Week 24 | Baseline levels of T cell associated biomarkers predict ACR70 response (improvement of 70% in the number of tender and number of swollen joints, and a 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept | Posted | Number | participants | Week 24 |
|
|
|
| Secondary | Number of Participants With European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24 | Baseline levels of T cell associated biomarkers predict EULAR good or moderate response (disease activity index for RA generated from tender and swollen joint count, patient global assessment, ESR or C-reactive protein) with subcutaneous abatacept | Posted | Number | participants | Week 24 |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 8 |
| 25 |
| headaches | Nervous system disorders | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D003240 |
| Connective Tissue Diseases |
| 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 |