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This Phase 4 study is being performed to examine the effects of Acthar for the indicated use of treatment of SLE. This study will enroll patients with steroid-dependent, persistently active SLE with arthritic and/or cutaneous involvement.
The study will involve two periods: an 8-week double-blind period, to provide placebo-controlled safety, efficacy, and pharmacodynamic data, and an optional open-label period, to examine the prolonged effects of Acthar maintenance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 2: Placebo/Acthar | Experimental | Participants receive Placebo in Part 1, but after completion of Week 8 in the double-blind phase, patients who received Placebo may choose to participate in the optional open-label phase where they will receive an Acthar maintenance regimen for 44 weeks. The initial Acthar regimen will be assigned based on the study medication regimen the patient received at the completion of the double-blind phase (Visit 6, Week 8). Acthar regimen during Part 2 may be adjusted based on the Investigator's judgment with the goal of achieving a stable Acthar regimen no later than Week 28. Once the stable Acthar regimen is achieved, the Investigator should consider tapering the steroid regimen to a low daily dose or completely discontinue. |
|
| Period 2: Acthar/Acthar | Experimental | After completion of Week 8 in the double-blind phase, patients who received Acthar may choose to participate in the optional open-label phase where they will receive an Acthar maintenance regimen for 44 weeks. The initial Acthar regimen will be assigned based on the study medication regimen the patient received at the completion of the double-blind phase (Visit 6, Week 8). Acthar regimen may be adjusted based on the Investigator's judgment with the goal of achieving a stable Acthar regimen no later than Week 28. Once the stable Acthar regimen is achieved, the Investigator should consider tapering the steroid regimen to a low daily dose or completely discontinue. |
|
| Period 1: Placebo | Placebo Comparator | Participants receive matching placebo (in 0.5 mL daily or in 1 mL every other day) for 4 weeks. In Weeks 5-8, they will taper the study medication. Participants will continue on their stable steroid regimen during this phase of the study. After completion of Week 8 in the double-blind phase, they may choose to participate in the optional open-label phase. Participants will continue on their stable steroid regimen during this phase of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acthar | Drug | Acthar is given by subcutaneous (SC) injection (shot under the skin), at a dose of 40 units daily or 80 units every other day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Meet the Definition of a Responder Within 4 Weeks | Participants are counted as responders based on two SLE indices: the Systemic Lupus Erythematosus Disease Activity Index amended by the SELENA group (SELENA-SLEDAI) and the British Isles Lupus Assessment Group (BILAG) Index.
OR
The BILAG is a transitional index that captures changing severity of clinical manifestations. It has an ordinal scale scoring system by design that produces an overview of disease activity across eight systems. The individual system scores were not intended to be summated into a global score. | within 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Meet the Definition of a Responder Within 8 Weeks | Participants are counted as responders based on:
OR
| within 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Patients with a recent history (≤ 2 months prior to screening) of starting prednisone (or equivalent) use
Patients with active nephritis defined as serum creatinine > 2.5 mg/dL or protein creatinine ratio (PCR) > 1.5 g/g, or patients that required hemodialysis within 3 months prior to screening
Active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis), requiring therapeutic intervention within 3 months prior to screening
Type 1 or type 2 diabetes mellitus (history of gestational diabetes mellitus is not an exclusion), or patients currently taking hypoglycemic medication
History of using certain medications prior to screening:
Contraindication per Acthar Prescribing Information: scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, or adrenal cortical hyperfunction
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mallinckrodt Investigational Site | Jonesboro | Arkansas | 72401 | United States | ||
| Mallinckrodt Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33687069 | Derived | Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2. |
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All participants were to receive their stable steroid regimen in addition to the study drug throughout the double-blind period (Period 1). If they completed Period 1, they were invited to participate in an open label period (Period 2). Those who received Placebo went into Placebo/Acthar, and those who received Acthar went into Acthar/Acthar.
38 enrolled participants were randomized 2:1:2:1 into four treatment groups, to receive Acthar 0.5 mL daily: Placebo 0.5 mL daily: Acthar 1 mL every other day: Placebo 1 mL every other day, during the double-blind period, along with their stable dose of steroids.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants receive their randomized regimen of placebo during the double-blind period |
| FG001 | Acthar | Participants receive their randomized regimen of Acthar during the double-blind period |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Period (8 Weeks) |
|
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| Period 1: Acthar | Experimental | Participants receive Acthar (40 units in 0.5 mL daily or 80 units in 1 mL every other day) for 4 weeks. In Weeks 5-8, they will taper the study medication. Participants will continue on their stable steroid regimen during this phase of the study. After completion of Week 8 in the double-blind phase, they may choose to participate in the optional open-label phase. Participants will continue on their stable steroid regimen during this phase of the study. |
|
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| Placebo | Drug | Placebo contains the same inactive ingredients as Acthar, and is given by SC injection |
|
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| Steroid Drug | Drug | The patient's steroid regimen 7.5 to 30 mg/day of prednisone or equivalent, chronic/stable within the 4 weeks prior to screening. |
|
|
| Score on the SELENA-SLEDAI Within 8 Weeks | SLEDAI was modeled on the basis of clinician global judgment. A participant's SELENA-SLEDAI total score is the sum of all marked SLE-related descriptors on a checklist developed by the SELENA Group (also referred to as hybrid SLEDAI). The scores of the descriptors range from 0 to 8. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity. Rows: Week 2, Week 4, Week 6, Week 8 | within 8 weeks |
| BILAG Total Score Within 8 Weeks | The BILAG is a transitional index that captures changing severity of clinical manifestations that produces an overview of disease activity across eight systems. The 8 systems are scored on a scale from 0=not present to 4=worse, for the 4 week period before the assessment. The lowest possible score is 0, and the highest possible score is 32. A higher score means the symptoms are worse. Rows: Baseline, Week 4, Week 8 | within 8 weeks |
| Physician's Global Assessment (PGA) of Disease Severity at Baseline | PGA of disease severity on a 100 mm visual analogue scale are categorized to the following: 0 point (none) = 0 mm; 1 point (mild) = >0 - 33.33 mm; 2 points (moderate) = >33.33 - 66.67 mm; and 3 points (severe) = >66.67 - 100 mm. The count of participants in each category is reported. | at Baseline |
| Physician's Global Assessment (PGA) of Disease Severity at Week 4 | PGA of disease severity on a 100 mm visual analogue scale are categorized to the following: 0 point (none) = 0 mm; 1 point (mild) = >0 - 33.33 mm; 2 points (moderate) = >33.33 - 66.67 mm; and 3 points (severe) = >66.67 - 100 mm. The count of participants in each category is reported. | at Week 4 |
| Physician's Global Assessment (PGA) of Disease Severity at Week 8 | PGA of disease severity on a 100 mm visual analogue scale are categorized to the following: 0 point (none) = 0 mm; 1 point (mild) = >0 - 33.33 mm; 2 points (moderate) = >33.33 - 66.67 mm; and 3 points (severe) = >66.67 - 100 mm. The count of participants in each category is reported. | at Week 8 |
| Number of Tender or Swollen Joints Within 8 Weeks | The doctor counted the number of tender or swollen joints at Baseline, at Week 4, and at Week 8 | at Baseline, Week 4, and Week 8 (within 8 weeks) |
| Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Within 8 Weeks | The CLASI consists of two scores the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI score ranges from 0 to 70, with higher scores indicating more severe skin disease. Rows: at Baseline, at Week 4, at Week 8 | at Baseline, Week 4 and Week 8 (within 8 weeks) |
| Krupp Fatigue Severity Score (FSS) Within 8 Weeks | The Krupp FSS is a scale to rate disability-related fatigue. Respondents use a scale ranging from 1 ("completely disagree") to 7 ("completely agree") to indicate their agreement with nine statements about fatigue. A visual analogue scale is also included with the scale; respondents are asked to denote the severity of their fatigue over the past 2 weeks by placing a mark on a line extending from "no fatigue" to "fatigue as bad as could be." Higher scores on the scale are indicative of more severe fatigue. This validated fatigue severity scale measures impact of fatigue with a 9-item questionnaire, with a 7-point Likert scale for each question. Total score ranges from 0 (best possible outcome) to 63 (worst possible fatigue). Rows: at Baseline, at Week 4, at Week 8 | at Baseline, Week 4 and Week 8 (within 8 weeks) |
| Mean Score on the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) Within 8 Weeks | The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicate improvement. Rows: at Baseline, at Week 4, at Week 8 | at Baseline, Week 4 and Week 8 (within 8 weeks) |
| Mean Score on the Mental Component Scale (MCS) of the Short Form 36 Health Status Questionnaire (SF-36) Within 8 Weeks | The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicate improvement. | at Baseline, Week 4 and Week 8 (within 8 weeks) |
| Number of Participants Who Meet the Definition of a Responder at Week 52 | Participants are counted as responders based on:
OR
| at Week 52 |
| Score on the SELENA-SLEDAI at Week 52 | SLEDAI was modeled on the basis of clinician global judgment. A participant's SELENA-SLEDAI total score is the sum of all marked SLE-related descriptors on a checklist developed by the SELENA Group (also referred to as hybrid SLEDAI). The scores of the descriptors range from 0 to 8. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity. | at Week 52 |
| Physician's Global Assessment (PGA) of Disease Severity at Week 52 | PGA of disease severity on a 100 mm visual analogue scale are categorized to the following: 0 point (none) = 0 mm; 1 point (mild) = >0 - 33.33 mm; 2 points (moderate) = >33.33 - 66.67 mm; and 3 points (severe) = >66.67 - 100 mm. The count of participants in each category is reported. | at Week 52 |
| Number of Tender or Swollen Joints at Week 52 | The doctor counted the number of tender or swollen joints at Week 52. | at Week 52 |
| Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) at Week 52 | The CLASI consists of two scores the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI score ranges from 0 to 70, with higher scores indicating more severe skin disease. | at Week 52 |
| Krupp Fatigue Severity Score (FSS) at Week 52 | The Krupp FSS is a scale to rate disability-related fatigue. Respondents use a scale ranging from 1 ("completely disagree") to 7 ("completely agree") to indicate their agreement with nine statements about fatigue. A visual analogue scale is also included with the scale; respondents are asked to denote the severity of their fatigue over the past 2 weeks by placing a mark on a line extending from "no fatigue" to "fatigue as bad as could be." Higher scores on the scale are indicative of more severe fatigue. This validated fatigue severity scale measures impact of fatigue with a 9-item questionnaire, with a 7-point Likert scale for each question. Total score ranges from 0 (best possible outcome) to 63 (worst possible fatigue). | at Week 52 |
| Mean Score on the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) at Week 52 | The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicate improvement. | at Week 52 |
| Mean Score on the Mental Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) at Week 52 | The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicate improvement. | at Week 52 |
| Number of Participants With a Relapse Within 52 Weeks | within 52 weeks |
| La Jolla |
| California |
| 92037 |
| United States |
| Mallinckrodt Investigational Site | La Palma | California | 90623 | United States |
| Mallinckrodt Investigational Site | Long Beach | California | 90806 | United States |
| Mallinckrodt Investigational Site | Upland | California | 91786 | United States |
| Mallinckrodt Investigational Site | Brandon | Florida | 33511 | United States |
| Mallinckrodt Investigational Site | Clearwater | Florida | 33765 | United States |
| Mallinckrodt Investigational Site | Miami Lakes | Florida | 33014 | United States |
| Mallinckrodt Investigational Site | Orlando | Florida | 32806 | United States |
| Mallinckrodt Investigational Site | Tampa | Florida | 33614 | United States |
| Mallinckrodt Investigational Site | Granger | Indiana | 46530 | United States |
| Mallinckrodt Investigational Site | Baton Rouge | Louisiana | 70809 | United States |
| Mallinckrodt Investigational Site | Lansing | Michigan | 48910 | United States |
| Mallinckrodt Investigational Site | Lansing | Michigan | 48917 | United States |
| Mallinckrodt Investigational Site | Brooklyn | New York | 11201 | United States |
| Mallinckrodt Investigational Site | Great Neck | New York | 11020 | United States |
| Mallinckrodt Investigational Site | New York | New York | 10016 | United States |
| Mallinckrodt Investigational Site | Charlotte | North Carolina | 28210 | United States |
| Mallinckrodt Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| Mallinckrodt Investigational Site | Wyomissing | Pennsylvania | 19610 | United States |
| Mallinckrodt Investigational Site | Houston | Texas | 77004 | United States |
| Mallinckrodt Investigational Site | Houston | Texas | 77034 | United States |
| FG002 | Placebo/Acthar | Participants who receive Placebo in Part 1, but Acthar in Part 2 |
| FG003 | Acthar/Acthar | Participants who receive Acthar in both Parts 1 and 2 |
| Modified Intent to Treat (mITT) |
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| COMPLETED |
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| NOT COMPLETED |
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| Open Label Period (44 Weeks) |
|
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All participants who received study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants who were randomized to receive Placebo in Period 1 |
| BG001 | Acthar | Participants who were randomized to receive Acthar in Period 1 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 Who Meet the Definition of a Responder Within 4 Weeks | Participants are counted as responders based on two SLE indices: the Systemic Lupus Erythematosus Disease Activity Index amended by the SELENA group (SELENA-SLEDAI) and the British Isles Lupus Assessment Group (BILAG) Index.
OR
The BILAG is a transitional index that captures changing severity of clinical manifestations. It has an ordinal scale scoring system by design that produces an overview of disease activity across eight systems. The individual system scores were not intended to be summated into a global score. | mITT | Posted | Count of Participants | Participants | within 4 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Meet the Definition of a Responder Within 8 Weeks | Participants are counted as responders based on:
OR
| mITT | Posted | Count of Participants | Participants | within 8 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Score on the SELENA-SLEDAI Within 8 Weeks | SLEDAI was modeled on the basis of clinician global judgment. A participant's SELENA-SLEDAI total score is the sum of all marked SLE-related descriptors on a checklist developed by the SELENA Group (also referred to as hybrid SLEDAI). The scores of the descriptors range from 0 to 8. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity. Rows: Week 2, Week 4, Week 6, Week 8 | mITT | Posted | Median | Full Range | score on a scale | within 8 weeks |
|
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| Secondary | BILAG Total Score Within 8 Weeks | The BILAG is a transitional index that captures changing severity of clinical manifestations that produces an overview of disease activity across eight systems. The 8 systems are scored on a scale from 0=not present to 4=worse, for the 4 week period before the assessment. The lowest possible score is 0, and the highest possible score is 32. A higher score means the symptoms are worse. Rows: Baseline, Week 4, Week 8 | mITT | Posted | Mean | Standard Deviation | score on a scale | within 8 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Physician's Global Assessment (PGA) of Disease Severity at Baseline | PGA of disease severity on a 100 mm visual analogue scale are categorized to the following: 0 point (none) = 0 mm; 1 point (mild) = >0 - 33.33 mm; 2 points (moderate) = >33.33 - 66.67 mm; and 3 points (severe) = >66.67 - 100 mm. The count of participants in each category is reported. | mITT | Posted | Count of Participants | Participants | at Baseline |
|
| ||||||||||||||||||||||||||||||
| Secondary | Physician's Global Assessment (PGA) of Disease Severity at Week 4 | PGA of disease severity on a 100 mm visual analogue scale are categorized to the following: 0 point (none) = 0 mm; 1 point (mild) = >0 - 33.33 mm; 2 points (moderate) = >33.33 - 66.67 mm; and 3 points (severe) = >66.67 - 100 mm. The count of participants in each category is reported. | mITT | Posted | Count of Participants | Participants | at Week 4 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Physician's Global Assessment (PGA) of Disease Severity at Week 8 | PGA of disease severity on a 100 mm visual analogue scale are categorized to the following: 0 point (none) = 0 mm; 1 point (mild) = >0 - 33.33 mm; 2 points (moderate) = >33.33 - 66.67 mm; and 3 points (severe) = >66.67 - 100 mm. The count of participants in each category is reported. | mITT | Posted | Count of Participants | Participants | at Week 8 |
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| Secondary | Number of Tender or Swollen Joints Within 8 Weeks | The doctor counted the number of tender or swollen joints at Baseline, at Week 4, and at Week 8 | mITT | Posted | Mean | Standard Deviation | Tender or Swollen Joints | at Baseline, Week 4, and Week 8 (within 8 weeks) |
|
| |||||||||||||||||||||||||||||
| Secondary | Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Within 8 Weeks | The CLASI consists of two scores the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI score ranges from 0 to 70, with higher scores indicating more severe skin disease. Rows: at Baseline, at Week 4, at Week 8 | mITT | Posted | Mean | Standard Deviation | score on a scale | at Baseline, Week 4 and Week 8 (within 8 weeks) |
|
| |||||||||||||||||||||||||||||
| Secondary | Krupp Fatigue Severity Score (FSS) Within 8 Weeks | The Krupp FSS is a scale to rate disability-related fatigue. Respondents use a scale ranging from 1 ("completely disagree") to 7 ("completely agree") to indicate their agreement with nine statements about fatigue. A visual analogue scale is also included with the scale; respondents are asked to denote the severity of their fatigue over the past 2 weeks by placing a mark on a line extending from "no fatigue" to "fatigue as bad as could be." Higher scores on the scale are indicative of more severe fatigue. This validated fatigue severity scale measures impact of fatigue with a 9-item questionnaire, with a 7-point Likert scale for each question. Total score ranges from 0 (best possible outcome) to 63 (worst possible fatigue). Rows: at Baseline, at Week 4, at Week 8 | mITT | Posted | Mean | Standard Deviation | score on a scale | at Baseline, Week 4 and Week 8 (within 8 weeks) |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Score on the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) Within 8 Weeks | The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicate improvement. Rows: at Baseline, at Week 4, at Week 8 | mITT | Posted | Mean | Standard Deviation | score on a scale | at Baseline, Week 4 and Week 8 (within 8 weeks) |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Score on the Mental Component Scale (MCS) of the Short Form 36 Health Status Questionnaire (SF-36) Within 8 Weeks | The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicate improvement. | mITT | Posted | Mean | Standard Deviation | score on a scale | at Baseline, Week 4 and Week 8 (within 8 weeks) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Meet the Definition of a Responder at Week 52 | Participants are counted as responders based on:
OR
| mITT with necessary data at Week 52 | Posted | Count of Participants | Participants | at Week 52 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Score on the SELENA-SLEDAI at Week 52 | SLEDAI was modeled on the basis of clinician global judgment. A participant's SELENA-SLEDAI total score is the sum of all marked SLE-related descriptors on a checklist developed by the SELENA Group (also referred to as hybrid SLEDAI). The scores of the descriptors range from 0 to 8. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity. | mITT with necessary data at Week 52 | Posted | Median | Full Range | score on a scale | at Week 52 |
|
| |||||||||||||||||||||||||||||
| Secondary | Physician's Global Assessment (PGA) of Disease Severity at Week 52 | PGA of disease severity on a 100 mm visual analogue scale are categorized to the following: 0 point (none) = 0 mm; 1 point (mild) = >0 - 33.33 mm; 2 points (moderate) = >33.33 - 66.67 mm; and 3 points (severe) = >66.67 - 100 mm. The count of participants in each category is reported. | mITT with necessary data at Week 52 | Posted | Count of Participants | Participants | at Week 52 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Tender or Swollen Joints at Week 52 | The doctor counted the number of tender or swollen joints at Week 52. | mITT with necessary data at Week 52 | Posted | Mean | Standard Deviation | Tender or Swollen Joints | at Week 52 |
|
| |||||||||||||||||||||||||||||
| Secondary | Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) at Week 52 | The CLASI consists of two scores the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI score ranges from 0 to 70, with higher scores indicating more severe skin disease. | mITT with necessary data at Week 52 | Posted | Mean | Standard Deviation | score on a scale | at Week 52 |
|
| |||||||||||||||||||||||||||||
| Secondary | Krupp Fatigue Severity Score (FSS) at Week 52 | The Krupp FSS is a scale to rate disability-related fatigue. Respondents use a scale ranging from 1 ("completely disagree") to 7 ("completely agree") to indicate their agreement with nine statements about fatigue. A visual analogue scale is also included with the scale; respondents are asked to denote the severity of their fatigue over the past 2 weeks by placing a mark on a line extending from "no fatigue" to "fatigue as bad as could be." Higher scores on the scale are indicative of more severe fatigue. This validated fatigue severity scale measures impact of fatigue with a 9-item questionnaire, with a 7-point Likert scale for each question. Total score ranges from 0 (best possible outcome) to 63 (worst possible fatigue). | mITT with necessary data at Week 52 | Posted | Mean | Standard Deviation | score on a scale | at Week 52 |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Score on the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) at Week 52 | The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicate improvement. | mITT with necessary data at Week 52 | Posted | Mean | Standard Deviation | score on a scale | at Week 52 |
|
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| Secondary | Mean Score on the Mental Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) at Week 52 | The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicate improvement. | mITT with necessary data at Week 52 | Posted | Mean | Standard Deviation | score on a scale | at Week 52 |
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| Secondary | Number of Participants With a Relapse Within 52 Weeks | mITT with necessary data at Week 52 | Posted | Count of Participants | Participants | within 52 weeks |
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Period 1: within 8 Weeks of double-blind period, Period 2: within 44 Weeks of open-label period
All treatment-emergent adverse events are listed in the non-serious AE module. Participants are counted only once per term.
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 | Period 1: Placebo | Participants who receive Placebo in Period 1 | 0 | 11 | 9 | 11 | ||
| EG001 | Period 1: Acthar | Participants who receive Acthar in Period 1 | 3 | 25 | 19 | 25 | ||
| EG002 | Period 2: Placebo/Acthar | Participants who receive Placebo in Period 1, but Acthar in Period 2 | 4 | 11 | 8 | 11 | ||
| EG003 | Period 2: Acthar/Acthar | Participants who receive Acthar in both Periods 1 and 2 | 2 | 22 | 19 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Pelvic infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Swollen tongue | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Burns first degree | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Blood pressure diastolic increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| False positive investigation result | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Ear haemorrhage | Ear and labyrinth disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Retinal degeneration | Eye disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Pelvic infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Urinary tract infection staphylococcal | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Vaginitis bacterial | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Computerised tomogram thorax abnormal | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Percussion test abnormal | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pleural rub | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Increased tendency to bruise | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypertrichosis | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
Non-serious adverse events (AEs) were not tabulated separately for these legacy results, so all treatment emergent adverse events are listed, and serious adverse events might be included.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt | 800-556-3314 | clinicaltrials@mnk.com |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Withdrawal by Subject |
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| Lack of Efficacy |
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| Reason not provided |
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| Male |
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| Black or African American |
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| Other |
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| Hispanic or Latino Ethnicity |
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