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

Psoriatic Arthritis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986373
• Other study ID #: M16-244
• Secondary ID: 2016-003113-94
• Status: Completed
• Phase: Phase 2
• Start date: December 15, 2016
• Est. completion date: July 30, 2018

Study information

• Verified date: May 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: July 30, 2018
• Est. primary completion date: July 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Biological:
• risankizumab
Risankizumab administered by subcutaneous injection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
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	From the first dose of study drug in this study until 20 weeks after the last dose of study drug (up to 56 weeks).
Secondary	Modified Total Sharp Score (mTSS): Change From Baseline (in the Lead-in Study) to Week 24 in the 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.	Baseline (Lead-in Study), Week 24 (Lead-in Study)
Secondary	mTSS: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 24
Secondary	mTSS: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 48
Secondary	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at 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.	Week 0
Secondary	Percentage of Participants Achieving ACR20 Response at 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.	Week 4
Secondary	Percentage of Participants Achieving ACR20 Response at 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.	Week 12
Secondary	Percentage of Participants Achieving ACR20 Response at 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.	Week 24
Secondary	Percentage of Participants Achieving ACR20 Response at 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.	Week 36
Secondary	Percentage of Participants Achieving ACR20 Response at 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.	Week 48
Secondary	Percentage of Participants Achieving ACR20 Response at 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.	Week 52
Secondary	Health Assessment Questionnaire Disability Index (HAQ-DI): Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 0
Secondary	HAQ-DI: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 4
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.	Baseline (Lead-in Study), Week 12
Secondary	HAQ-DI: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 24
Secondary	HAQ-DI: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 36
Secondary	HAQ-DI: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 48
Secondary	HAQ-DI: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 52
Secondary	Short Form Health Survey 36 (SF-36) Physical Component Summary (PCS) Score: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 0
Secondary	SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 4
Secondary	SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 12
Secondary	SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 24
Secondary	SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 36
Secondary	SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 48
Secondary	SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 52
Secondary	SF-36 Mental Component Summary (MCS) Score: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 0
Secondary	SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 4
Secondary	SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 12
Secondary	SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 24
Secondary	SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 36
Secondary	SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 48
Secondary	SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to 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.	Baseline (Lead-in Study), Week 52

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