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Response rate in placebo group for primary outcome was 100% on interim analysis.
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This research trial is for patients who have been diagnosed with systemic lupus erythematosus (SLE) with swollen, tender joints (which is called inflammatory polyarthritis) because of the SLE.
The purpose of this clinical research study is to evaluate the safety and effectiveness of treatment with abatacept (Abatacept) 125mg injected subcutaneously (under the skin) weekly for 16 weeks versus placebo injections(a substance with no active ingredients and therefore may have no treatment benefit) in subjects with SLE and inflammatory polyarthritis. The effectiveness will be assessed primarily by the number of swollen, tender joints (called a joint count) at each of study visits.
Study Medication Abatacept is approved in the U.S. for treating rheumatoid arthritis by prescription and has not been approved by the U.S. Food and Drug Administration for treating SLE yet.
In this study, subjects will receive treatment with either abatacept or placebo once a week for 16 weeks (a total of 16 injections).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abatacept also known as Orencia also known as CTLA4Ig | Active Comparator | 32 SLE patients to be treated with subcutaneous abatacept 125mg sq once a week for 16 weeks. |
|
| Placebo | Placebo Comparator | 32 SLE patients to be treated with subcutaneous placebo once a week for 16 weeks. Injection will be vehicle injected subcutaneously once a week for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abatacept also known as Orencia also known as CTLA4-Ig | Biological | 125mg injected subcutaneously weekly for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least a 20% Improvement From Baseline in Tender and Swollen 28 Joint Count | Assessed by physical exam. Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit. | Baseline, 8 Weeks, 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SLEDAI 2K | Systemic Lupus Erythematosus Disease Activity Index (Modified in the year 2000) - The SLEDAI-2K is a modified version of a composite score based on the presence or absence of clinical signs, clinical symptoms, and immunologic laboratory results taken within 10 days of the evaluations. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity. Decrease of 3 points in SLEDAI 2K is considered to be a clinically significant improvement. |
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Inclusion Criteria:
During the screening period and for up to 6 weeks after randomization, a daily prednisone (or equivalent) regimen of up to 20 mg daily may be initiated to treat the moderate to severe disease activity present at screening. The initial steroid regimen is not required if investigators or patients believe that the risks would outweigh the potential benefits. Patients who do not take any glucocorticoids during the study will be included in the treatment groups and analysis.
*Steroids should be tapered to a target dose of no more than 10 mg/day of prednisone (or equivalent) by the end of Week 8 (Day 56). The steroid regimen should be tapered as quickly as safely possible. Prednisone dose requirements higher than 10 mg daily at the 8 week visit will cause the patient to be ruled a non-responder for the abatacept treatment arm.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bevra Hahn, M.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA David Geffen School of Medicine, Division of Rheumatology | Los Angeles | California | 90095 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Abatacept | abatacept: 125mg injected subcutaneously weekly for 16 weeks |
| FG001 | Placebo | Placebo subcutaneous injection weekly for 16 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Abatacept | abatacept: 125mg injected subcutaneously weekly for 16 weeks |
| BG001 | Placebo | Placebo subcutaneous injection weekly for 16 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 at Least a 20% Improvement From Baseline in Tender and Swollen 28 Joint Count | Assessed by physical exam. Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit. | subjects that completed the 8 and 16 week study visits | Posted | Count of Participants | Participants | Baseline, 8 Weeks, 16 Weeks |
|
Adverse events were collected for 20 weeks after initial dose (visit 1)
We used clinicaltrials.gov definitions
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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 | abatacept: 125mg injected subcutaneously weekly for 16 weeks | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| flare of lupus nephritis | Renal and urinary disorders | Systematic Assessment | Patient developed increased proteinuria, was removed from clinical trial and treated with increased immunosuppression and problem resolved, Judged not related to study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin reaction at injection site | Skin and subcutaneous tissue disorders | Systematic Assessment | soreness and tenderness around point of subcutaneous injection for 1-2 days post injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bevra Hahn | University of California at Los Angeles | 8184869745 | 8184869745 | bhahn@mednet.ucla.edu |
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| 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 | Jun 11, 2018 | Sep 15, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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|
| Placebo | Drug |
|
| Baseline, 16 weeks |
| Change in the PGA Score | Physician's Global Assessment (PGA) is a physician rating of patient's disease activity, with a range 0-3. A change of 0.8 points on a 3 point scale or less is considered as stable. Lower score means better outcome | Baseline, 16 weeks |
| Clinical Disease Activity Index (CDAI) Index Score | CDAI is a simplified index for assessing disease activity comprising swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI less than equal to (<=) 2.8 indicates disease remission, greater than (>) 2.8 to 10 = low disease activity, greater than (>) 10 to 22 = moderate disease activity, and >22 = high disease activity. | 16 weeks |
| Synovitis, Tenosynovitis and Erosions Scores (GSUS and PDUS) | Using ultrasound analysis, (Gray scale ultrasound) represents synovitis/tenosynovitis and identifies erosions. PDUS (power Doppler ultrasound) measures intensity of soft tissue inflammation by blood flow. 30 joints were evaluated using a 0 to 3 point scale for each joint and the sum of these represents PDUS. The Power Doppler Synovitis Score (PDUS) ranges from 0 to 90. Scores of 0 indicate the least amount of inflammation. A higher value of the total score for PDUS represents more severe disease level. 30 joints were evaluated using a 0 to 3 point scale for each joint and the sum of these represents GSUS. The grey scale synovial hypertrophy score (GSUS) ranges from 0 to 90. Scores of 0 indicate the least amount of inflammation of the joint. A higher value of the total score for GSUS represents more severe disease level. | Baseline, 16 weeks |
| Number of AEs and SAEs | Total number of AEs and total number of SAEs as well as those AEs/SAEs which may be related to the study drug | 16 weeks |
| Number of Tender and Swollen Joints | Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit | baseline, 4, 8, 12 and 16 weeks |
| Change in the Total Sum of Tender and Swollen Joints | Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit | Baseline, 16 weeks |
| Number of Patients Who Tapered Prednisone to <10mg/Day | This analysis is for the subset of patients who start the study taking 10 to 20mg of prednisone per day. | 16 weeks |
| Mean Prednisone Dose (mg/Day) | prednisone dose (mg/day) is recorded at baseline, 8 and 16 weeks for each subject being assessed at that study visit. Then a mean for all the subjects in each group at each time point was calculated. | Baseline, 8 and 16 weeks |
| University of California, San Diego |
| San Diego |
| California |
| 92093 |
| United States |
| Lost to Follow-up |
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| education | Count of Participants | Participants |
|
| insurance | Count of Participants | Participants |
|
| smoking history | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in SLEDAI 2K | Systemic Lupus Erythematosus Disease Activity Index (Modified in the year 2000) - The SLEDAI-2K is a modified version of a composite score based on the presence or absence of clinical signs, clinical symptoms, and immunologic laboratory results taken within 10 days of the evaluations. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity. Decrease of 3 points in SLEDAI 2K is considered to be a clinically significant improvement. | completers at 16 weeks | Posted | Mean | Standard Deviation | score on a scale | Baseline, 16 weeks |
|
|
|
| Secondary | Change in the PGA Score | Physician's Global Assessment (PGA) is a physician rating of patient's disease activity, with a range 0-3. A change of 0.8 points on a 3 point scale or less is considered as stable. Lower score means better outcome | SLE subjects completing 16 weeks of treatment or placebo and attending the 16-week physician assessment visit. | Posted | Mean | Standard Deviation | points on scale | Baseline, 16 weeks |
|
|
|
| Secondary | Clinical Disease Activity Index (CDAI) Index Score | CDAI is a simplified index for assessing disease activity comprising swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI less than equal to (<=) 2.8 indicates disease remission, greater than (>) 2.8 to 10 = low disease activity, greater than (>) 10 to 22 = moderate disease activity, and >22 = high disease activity. | sle subjects that completed 16 week assessment visit | Posted | Mean | Standard Deviation | score on a scale | 16 weeks |
|
|
|
| Secondary | Synovitis, Tenosynovitis and Erosions Scores (GSUS and PDUS) | Using ultrasound analysis, (Gray scale ultrasound) represents synovitis/tenosynovitis and identifies erosions. PDUS (power Doppler ultrasound) measures intensity of soft tissue inflammation by blood flow. 30 joints were evaluated using a 0 to 3 point scale for each joint and the sum of these represents PDUS. The Power Doppler Synovitis Score (PDUS) ranges from 0 to 90. Scores of 0 indicate the least amount of inflammation. A higher value of the total score for PDUS represents more severe disease level. 30 joints were evaluated using a 0 to 3 point scale for each joint and the sum of these represents GSUS. The grey scale synovial hypertrophy score (GSUS) ranges from 0 to 90. Scores of 0 indicate the least amount of inflammation of the joint. A higher value of the total score for GSUS represents more severe disease level. | completers of 16 weeks of treatment/placebo at one study center (UCLA) | Posted | Mean | Standard Deviation | score on scale | Baseline, 16 weeks |
|
|
|
| Secondary | Number of AEs and SAEs | Total number of AEs and total number of SAEs as well as those AEs/SAEs which may be related to the study drug | All subjects dosed with either abatacept or placebo at least once. | Posted | Number | adverse events | 16 weeks |
|
|
|
| Secondary | Number of Tender and Swollen Joints | Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit | Each timepoint reports the number of participants who attended each visit for physician assessment | Posted | Mean | Standard Deviation | joints | baseline, 4, 8, 12 and 16 weeks |
|
|
|
| Secondary | Change in the Total Sum of Tender and Swollen Joints | Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit | Posted | Mean | Standard Deviation | Joints | Baseline, 16 weeks |
|
|
|
| Secondary | Number of Patients Who Tapered Prednisone to <10mg/Day | This analysis is for the subset of patients who start the study taking 10 to 20mg of prednisone per day. | This analysis is for the subset of patients who start the study taking 10 to 20mg of prednisone per day. Among all the subjects entered, 6 in each group were taking 10 mg of prednisone daily or higher at baseline | Posted | Number | participants | 16 weeks |
|
|
|
| Secondary | Mean Prednisone Dose (mg/Day) | prednisone dose (mg/day) is recorded at baseline, 8 and 16 weeks for each subject being assessed at that study visit. Then a mean for all the subjects in each group at each time point was calculated. | Results are reported for the number of participants who completed the study visit/assessment at each time point | Posted | Mean | Standard Deviation | mg per day | Baseline, 8 and 16 weeks |
|
|
|
| 15 |
| 1 |
| 15 |
| 6 |
| 15 |
| EG001 | Placebo | Placebo subcutaneous injection weekly for 16 weeks | 0 | 13 | 0 | 13 | 3 | 13 |
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| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| baseline PDUS |
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| 16 week PDUS |
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| AEs possibly related |
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| AEs probably related |
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| AEs grade III or higher |
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| SAEs |
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| week 4 |
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| week 8 |
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| week 12 |
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| week 16 |
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| 8 weeks |
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| 16 weeks |
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