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The objectives of this study were to evaluate the usability of the combination product of risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and tolerability of risankizumab administered by AI for the treatment of adult participants with moderate to severe plaque psoriasis.
This was a Phase 3 multicenter, single-arm, open-label study that evaluated usability and efficacy of the risankizumab-AI combination product. The study included a 30-day screening period with study visits at Weeks 0, 4, 16, 28, and 40 with a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug (Week 48). Study drug dosing consisted of 4 self-administered doses given subcutaneously on Weeks 0, 4, 16, and 28. Dosing on Weeks 4 and 16 was self-administered at home.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab | Experimental | Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Risankizumab to be injected subcutaneously (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Observer Rating of Successful Participant Self-administration | Successful participant self-administration is defined as successfully completed the sequence of 4 critical steps in the Instructions for Use (IFU) without errors to administer study drug via the autoinjector. The steps are "chose an appropriate injection site"; "removed cap from autoinjector"; "activated the injection"; and "performed a complete injection". | Day 1 and Week 28 |
| Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100. | At Week 16 |
| Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. | At Week 16 |
| Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked.The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Negative values indicate an improvement from baseline. |
Inclusion Criteria:
Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit
Participant meets following disease activity criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Research Associates /ID# 210634 | Glendale | Arizona | 85308 | United States | ||
| Cognitive Clinical Trials /ID# 210770 |
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Intent-to-treat (ITT) population: all participants who received at least one dose of study drug
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| ID | Title | Description |
|---|---|---|
| FG000 | Risankizumab | Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 20, 2019 | Apr 19, 2021 |
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| Autoinjector | Device | Single dose pre-filled autoinjector containing risankizumab for SC injection |
|
| At Week 16 |
| Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100. | At Week 16 |
| Percentage of Participants Who Had No Potential Hazards as Measured by an Observer | Potential hazards are measured by an observer on the possible use-related hazards checklist for self-administration with the autoinjector. Hazards include injection at incorrect site; administration delayed because of cap removal difficulties; slip hazard during cap disposal attempt; small component swallowed after incorrect disposal of cap; patient received less medication than intended; needle shield did not deploy and resulted in sharps exposure; and pen not discarded properly and resulted in a biohazard for others. | Day 1 and Week 28 |
| Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) | Participants completed the Self-Injection Assessment Questionnaire (SIAQ), an instrument previously validated in those with rheumatoid arthritis, on an electronic patient-report outcome (ePRO) device. The POST module includes four principal causal domains: feelings about injections, self-confidence, pain and reaction during or after the injection, and ease of use, plus two additional domains on satisfaction with self-injection and self-image. Participants rate each item of the SIAQ 20 to 40 minutes following injections, and the ratings are transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Higher domain scores indicate wider acceptability by subjects to use the autoinjector. | Day 1, Week 4, Week 16, Week 28 |
| Baseline, Week 4, and Week 16 |
| Scottsdale |
| Arizona |
| 85258-4446 |
| United States |
| Burke Pharmaceutical Research /ID# 211386 | Hot Springs | Arkansas | 71913-6404 | United States |
| Bakersfield Derma & Skin Cance /ID# 210773 | Bakersfield | California | 93309 | United States |
| Encino Research Center / T. Jo /ID# 211735 | Encino | California | 91436 | United States |
| Tien Q Nguyen MD, Inc /ID# 210775 | Fountain Valley | California | 92708-3701 | United States |
| UC Davis Health /ID# 210411 | Sacramento | California | 95816 | United States |
| Dermatology Physicians of CT /ID# 210637 | Shelton | Connecticut | 06484-6211 | United States |
| Florida Academic Centers Research /ID# 210337 | Coral Gables | Florida | 33134 | United States |
| Medallion Clinical Research Institute, LLC /ID# 210329 | Naples | Florida | 34102 | United States |
| Renstar Medical Research /ID# 210878 | Ocala | Florida | 34470 | United States |
| Epiphany Dermatology /ID# 211493 | Overland Park | Kansas | 66215 | United States |
| DermAssociates /ID# 210838 | Rockville | Maryland | 20850 | United States |
| Great Lakes Research, Inc. /ID# 210192 | Bay City | Michigan | 48602 | United States |
| Somerset Skin Centre /ID# 211596 | Troy | Michigan | 48084 | United States |
| Central Dermatology, PC /ID# 210301 | St Louis | Missouri | 63117 | United States |
| AllCutis Research Inc /ID# 211429 | Portsmouth | New Hampshire | 03801 | United States |
| Medication Management, LLC /ID# 213217 | Greensboro | North Carolina | 27408 | United States |
| Oregon Medical Res Center PC /ID# 210334 | Portland | Oregon | 97223 | United States |
| University of Pittsburgh MC /ID# 210839 | Pittsburgh | Pennsylvania | 15260 | United States |
| Center for Clinical Studies /ID# 211565 | Cypress | Texas | 77433 | United States |
| Center for Clinical Studies /ID# 210362 | Houston | Texas | 77004 | United States |
| Suzanne Bruce and Associates /ID# 212210 | Houston | Texas | 77056 | United States |
| Austin Institute for Clinical Research /ID# 212203 | Pflugerville | Texas | 78660 | United States |
| Premier Clinical Research /ID# 212209 | Spokane | Washington | 99202 | United States |
| Froedtert Mem Lutheran Hosp /ID# 210194 | Milwaukee | Wisconsin | 53226 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population: all participants who received at least one dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Risankizumab | Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Prior Use of Systemic Biologic for Psoriasis | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Static Physician Global Assessment (sPGA) Score at Baseline | The sPGA is an investigator assessment of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. | Count of Participants | Participants | No |
| |||||||||||||||||||||
| Psoriasis Area and Severity Index (PASI) Score at Baseline | The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. | Mean | Standard Deviation | units on a scale |
| |||||||||||||||||||||
| Body Surface Area (BSA) Psoriasis Involvement at Baseline | Mean | Standard Deviation | Percentage of body surface area affected |
| ||||||||||||||||||||||
| Duration of Plaque Psoriasis | Mean | Standard Deviation | years |
|
| 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 | Percentage of Participants With an Observer Rating of Successful Participant Self-administration | Successful participant self-administration is defined as successfully completed the sequence of 4 critical steps in the Instructions for Use (IFU) without errors to administer study drug via the autoinjector. The steps are "chose an appropriate injection site"; "removed cap from autoinjector"; "activated the injection"; and "performed a complete injection". | Intent-to-treat (ITT) population: all participants who received at least one dose of study drug and had available data | Posted | Number | percentage of participants | Day 1 and Week 28 |
|
|
| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100. | Intent-to-treat (ITT) population: all participants who received at least one dose of study drug; those with missing data were imputed as non-responders | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 16 |
|
| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. | Intent-to-treat (ITT) population: all participants who received at least one dose of study drug; those with missing data were imputed as non-responders | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 16 |
|
| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100. | Intent-to-treat (ITT) population: all participants who received at least one dose of study drug; those with missing data were imputed as non-responders | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 16 |
|
| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100. | Intent-to-treat (ITT) population: all participants who received at least one dose of study drug; those with missing data were imputed as non-responders | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 16 |
|
| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Had No Potential Hazards as Measured by an Observer | Potential hazards are measured by an observer on the possible use-related hazards checklist for self-administration with the autoinjector. Hazards include injection at incorrect site; administration delayed because of cap removal difficulties; slip hazard during cap disposal attempt; small component swallowed after incorrect disposal of cap; patient received less medication than intended; needle shield did not deploy and resulted in sharps exposure; and pen not discarded properly and resulted in a biohazard for others. | Intent-to-treat (ITT) population: all participants who received at least one dose of study drug and had available data | Posted | Number | percentage of participants | Day 1 and Week 28 |
|
| |||||||||||||||||||||||||||||
| Primary | Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) | Participants completed the Self-Injection Assessment Questionnaire (SIAQ), an instrument previously validated in those with rheumatoid arthritis, on an electronic patient-report outcome (ePRO) device. The POST module includes four principal causal domains: feelings about injections, self-confidence, pain and reaction during or after the injection, and ease of use, plus two additional domains on satisfaction with self-injection and self-image. Participants rate each item of the SIAQ 20 to 40 minutes following injections, and the ratings are transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Higher domain scores indicate wider acceptability by subjects to use the autoinjector. | Intent-to-treat (ITT) population: all participants who received at least one dose of study drug and had available data | Posted | Mean | Standard Deviation | units on a scale | Day 1, Week 4, Week 16, Week 28 |
|
| ||||||||||||||||||||||||||||
| Other Pre-specified | Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked.The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Negative values indicate an improvement from baseline. | Intent-to-treat (ITT) population: all randomized participants with a non-missing baseline measurement and at least one post-baseline value | Posted | Least Squares Mean | 95% Confidence Interval | percent change from Baseline | Baseline, Week 4, and Week 16 |
|
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Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 20 weeks after last study drug administration, up to 48 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 20 weeks have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
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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 | Risankizumab | Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28 | 0 | 108 | 6 | 108 | 12 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| THERMAL BURN | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| PROSTATITIS | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2020 | Apr 19, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000601773 | risankizumab |
Not provided
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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or other Pacific Islander |
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| Other |
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| Multiple |
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| Missing |
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