A Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study M16-002 (NCT02719171)

A Phase 2 Single-Arm Open-Label Extension Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study M16-002 (1311.5)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02986373

Enrollment

145

Registered

2016-12-08

Start date

2016-12-15

Completion date

2018-07-30

Last updated

2019-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis

Keywords

risankizumab, ABBV-066, BI655066

Brief summary

This is an open-label extension (OLE) study to assess the efficacy, safety and tolerability of risankizumab in participants with psoriatic arthritis (PsA).

Detailed description

Participants who had completed all doses of study drug and the Week 24 visit of M16-002 (NCT02719171; the lead-in study) were eligible to enroll in M16-244 (this study). Participants were allowed to either finish the Week 24 visit of the lead-in study and take the first dose of study drug for this study on the same day, or delay the start of this study up to 8 weeks if needed.

Interventions

BIOLOGICALrisankizumab

Risankizumab administered by subcutaneous injection.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants who have completed all doses of study drug and Week 24 visit of the lead-in study. * Women of childbearing potential who are sexually active, must agree to use at least one accepted method of contraception throughout the study, including 20 weeks after last dose of study drug is given. * Women of childbearing potential must have a negative urine pregnancy test at Baseline (Week 0/V1). * Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any study specific procedures. * Participant is judged to be in good health as determined by the Investigator.

Exclusion criteria

* Female participant who is pregnant, breastfeeding or is considering becoming pregnant during study participation, including 20 weeks after the last dose of study drug is given. * Premature discontinuation of the study drug in the lead-in study for any reason. * Use of a biologic treatment other than risankizumab since first dose of study drug in the lead-in study. * Time elapsed is \> 8 weeks since the Week 24 visit in the lead-in study. * Active systemic infections during the last 2 weeks (exception: common cold) prior to the first dose, as assessed by the investigator.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Adverse Events	From the first dose of study drug in this study until 20 weeks after the last dose of study drug (up to 56 weeks).	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as an AE that began or worsened in severity after initiation of study drug and 20 weeks (140 days) after last dose. Abbreviations: NMSC=non-melanoma skin cancer

Secondary

Measure	Time frame	Description
mTSS: Change From Baseline (in the Lead-in Study) to Week 24	Baseline (Lead-in Study), Week 24	The mTSS is a measure of change in joint health. X-rays of hands, wrists, and feet (including distal interphalangeal joints) were obtained at Week 24 and Week 48. Totals for hands and feet for erosion scores (range 0 to 320) and joint space narrowing scores (range 0 to 208) were calculated and added to obtain the mTSS (range = 0 \[normal\] to 528 \[maximal disease\]). An increase in mTSS from Baseline represents disease progression and/or joint worsening; no progression was defined as a change of ≤0.5. Baseline is defined as baseline in the lead-in study.
mTSS: Change From Baseline (in the Lead-in Study) to Week 48	Baseline (Lead-in Study), Week 48	The mTSS is a measure of change in joint health. X-rays of hands, wrists, and feet (including distal interphalangeal joints) were obtained at Week 24 and Week 48. Totals for hands and feet for erosion scores (range 0 to 320) and joint space narrowing scores (range 0 to 208) were calculated and added to obtain the mTSS (range = 0 \[normal\] to 528 \[maximal disease\]). An increase in mTSS from Baseline represents disease progression and/or joint worsening; no progression was defined as a change of ≤0.5. Baseline is defined as baseline in the lead-in study.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 0	Week 0	Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 0: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity visual analog scale (VAS), Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.
Percentage of Participants Achieving ACR20 Response at Week 4	Week 4	Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 4: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.
Percentage of Participants Achieving ACR20 Response at Week 12	Week 12	Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 12: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.
Percentage of Participants Achieving ACR20 Response at Week 24	Week 24	Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 24: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.
Percentage of Participants Achieving ACR20 Response at Week 36	Week 36	Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 36: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.
Percentage of Participants Achieving ACR20 Response at Week 48	Week 48	Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 48: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.
Percentage of Participants Achieving ACR20 Response at Week 52	Week 52	Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 52: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.
Health Assessment Questionnaire Disability Index (HAQ-DI): Change From Baseline (in the Lead-in Study) to Week 0	Baseline (Lead-in Study), Week 0	The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \< 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 4	Baseline (Lead-in Study), Week 4	The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \< 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 12	Baseline (Lead-in Study), Week 12	The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \< 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 24	Baseline (Lead-in Study), Week 24	The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \< 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 36	Baseline (Lead-in Study), Week 36	The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \< 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 48	Baseline (Lead-in Study), Week 48	The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \< 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
Modified Total Sharp Score (mTSS): Change From Baseline (in the Lead-in Study) to Week 24 in the Lead-in Study	Baseline (Lead-in Study), Week 24 (Lead-in Study)	The mTSS is a measure of change in joint health. X-rays of hands, wrists, and feet (including distal interphalangeal joints) were obtained at Week 24 and Week 48. Totals for hands and feet for erosion scores (range 0 to 320) and joint space narrowing scores (range 0 to 208) were calculated and added to obtain the mTSS (range = 0 \[normal\] to 528 \[maximal disease\]). An increase in mTSS from Baseline represents disease progression and/or joint worsening; no progression was defined as a change of ≤0.5. Baseline is defined as baseline in the lead-in study.
Short Form Health Survey 36 (SF-36) Physical Component Summary (PCS) Score: Change From Baseline (in the Lead-in Study) to Week 0	Baseline (Lead-in Study), Week 0	The SF-36 Health determined 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 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 4	Baseline (Lead-in Study), Week 4	The SF-36 Health determined 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 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 12	Baseline (Lead-in Study), Week 12	The SF-36 Health determined 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 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 24	Baseline (Lead-in Study), Week 24	The SF-36 Health determined 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 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 36	Baseline (Lead-in Study), Week 36	The SF-36 Health determined 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 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 48	Baseline (Lead-in Study), Week 48	The SF-36 Health determined 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 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 52	Baseline (Lead-in Study), Week 52	The SF-36 Health determined 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 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
SF-36 Mental Component Summary (MCS) Score: Change From Baseline (in the Lead-in Study) to Week 0	Baseline (Lead-in Study), Week 0	The SF-36 determined 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 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 4	Baseline (Lead-in Study), Week 4	The SF-36 determined 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 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 12	Baseline (Lead-in Study), Week 12	The SF-36 determined 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 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 24	Baseline (Lead-in Study), Week 24	The SF-36 determined 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 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 36	Baseline (Lead-in Study), Week 36	The SF-36 determined 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 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 48	Baseline (Lead-in Study), Week 48	The SF-36 determined 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 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 52	Baseline (Lead-in Study), Week 52	The SF-36 determined 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 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.
HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 52	Baseline (Lead-in Study), Week 52	The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \< 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.

Participant flow

Pre-assignment details

Participants who had completed all doses of study drug and the Week 24 visit of M16-002 (NCT02719171; lead-in study) were eligible to enroll in M16-244 (this study).

Participants by arm

Arm	Count
Risankizumab Participants received open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 12, 24, and 36.	145
Total	145

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	4
Overall Study	Lost to Follow-up	1
Overall Study	Other	24
Overall Study	Withdrawal by Subject	10

Baseline characteristics

Characteristic	Risankizumab
Age, Continuous	50.4 years STANDARD_DEVIATION 12.52
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	138 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	21 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants
Race (NIH/OMB) White	119 Participants
Sex: Female, Male Female	61 Participants
Sex: Female, Male Male	84 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 145
other Total, other adverse events	16 / 145
serious Total, serious adverse events	5 / 145

Outcome results

Primary

Number of Participants With Adverse Events

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as an AE that began or worsened in severity after initiation of study drug and 20 weeks (140 days) after last dose. Abbreviations: NMSC=non-melanoma skin cancer

Time frame: From the first dose of study drug in this study until 20 weeks after the last dose of study drug (up to 56 weeks).

Population: Safety Analysis Set: consists of all participants who have received at least 1 dose of study medication in Study M16-244 (this study).

Arm	Measure	Group	Value (NUMBER)
Risankizumab	Number of Participants With Adverse Events	Any AE	87 participants
Risankizumab	Number of Participants With Adverse Events	Any AE at least possibly drug related	22 participants
Risankizumab	Number of Participants With Adverse Events	Any SAE at least possibly drug related	1 participants
Risankizumab	Number of Participants With Adverse Events	Any severe AE	7 participants
Risankizumab	Number of Participants With Adverse Events	Any SAE	5 participants
Risankizumab	Number of Participants With Adverse Events	Any AE leading to discontinuation of study drug	5 participants
Risankizumab	Number of Participants With Adverse Events	Any major adverse cardiac events (by adjudication)	2 participants
Risankizumab	Number of Participants With Adverse Events	Any Serious Infections Events	2 participants
Risankizumab	Number of Participants With Adverse Events	Any tuberculosis events	2 participants
Risankizumab	Number of Participants With Adverse Events	Any malignant tumor events	1 participants
Risankizumab	Number of Participants With Adverse Events	Any malignancies excluding NMSC events	1 participants

Secondary

HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 12

The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \< 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.

Time frame: Baseline (Lead-in Study), Week 12