Clinical Trial Results:
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)
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Summary
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EudraCT number |
2016-003113-94 |
Trial protocol |
CZ DE FI ES BE FR |
Global end of trial date |
30 Jul 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Jul 2019
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First version publication date |
13 Jul 2019
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
M16-244
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02986373 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
AbbVie Deutschland GmbH & Co. KG
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Sponsor organisation address |
AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
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Public contact |
Global Medical Services, AbbVie, 001 800-633-9110,
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Scientific contact |
Maureen Kelly, MD, AbbVie, maureen.kelly@abbvie.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Jul 2018
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Jul 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
This is an open-label extension (OLE) study to assess the efficacy, safety and tolerability of risankizumab in participants with psoriatic arthritis (PsA).
Participants who had completed all doses of study drug and the Week 24 visit of M16-002 (1311.5; 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.
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Protection of trial subjects |
Subject or his or her representative read and understood the information provided about the study and gave written permission.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Dec 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 5
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Country: Number of subjects enrolled |
Canada: 6
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Country: Number of subjects enrolled |
Czech Republic: 13
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Country: Number of subjects enrolled |
Finland: 15
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Country: Number of subjects enrolled |
France: 4
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Country: Number of subjects enrolled |
Japan: 14
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Country: Number of subjects enrolled |
Poland: 38
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Country: Number of subjects enrolled |
Spain: 9
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Country: Number of subjects enrolled |
Taiwan: 5
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Country: Number of subjects enrolled |
United States: 36
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Worldwide total number of subjects |
145
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EEA total number of subjects |
84
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
121
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From 65 to 84 years |
24
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||
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Pre-assignment
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Screening 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). | ||||||||||||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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Risankizumab | ||||||||||||||||
Arm description |
Participants received open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 12, 24, and 36. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Risankizumab
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Investigational medicinal product code |
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Other name |
ABBV-066, BI 655066
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Risankizumab administered by subcutaneous injection.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial (overall period)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Risankizumab
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Reporting group description |
Participants received open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 12, 24, and 36. | ||
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End point title |
Number of Participants With Adverse Events [1] | ||||||||||||||||||||||||||||
End point description |
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.
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End point type |
Primary
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End point timeframe |
From the first dose of study drug in this study until 20 weeks after the last dose of study drug (up to 56 weeks).
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive data are summarized for this end point per protocol. |
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| Notes [2] - Safety Analysis Set: all participants that received at least 1 dose of study drug in this study. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Modified Total Sharp Score (mTSS): Change From Baseline (in the Lead-in Study) to Week 24 in the Lead-in Study | ||||||||
End point description |
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. Analysis based on derivation method #1 per the lead-in study. Baseline is defined as baseline in the lead-in study.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 24 (Lead-in Study)
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| Notes [3] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
mTSS: Change From Baseline (in the Lead-in Study) to Week 24 | ||||||||
End point description |
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. Analysis based on derivation method #1 per the lead-in study. Baseline is defined as baseline in the lead-in study.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 24
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| Notes [4] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
mTSS: Change From Baseline (in the Lead-in Study) to Week 48 | ||||||||
End point description |
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. Analysis based on derivation method #1 per the lead-in study. Baseline is defined as baseline in the lead-in study.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 48
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| Notes [5] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 0 | ||||||||
End point description |
Response defined by ACR20 criteria (improvement from baseline) 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.
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End point type |
Secondary
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End point timeframe |
Week 0
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| Notes [6] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants Achieving ACR20 Response at Week 4 | ||||||||
End point description |
Response defined by ACR20 criteria (improvement from baseline) 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.
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End point type |
Secondary
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End point timeframe |
Week 4
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| Notes [7] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants Achieving ACR20 Response at Week 12 | ||||||||
End point description |
Response defined by ACR20 criteria (improvement from baseline) 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 baseline in the lead-in study.
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End point type |
Secondary
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End point timeframe |
Week 12
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| Notes [8] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants Achieving ACR20 Response at Week 24 | ||||||||
End point description |
Response defined by ACR20 criteria (improvement from baseline) 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.
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End point type |
Secondary
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End point timeframe |
Week 24
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| Notes [9] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants Achieving ACR20 Response at Week 36 | ||||||||
End point description |
Response defined by ACR20 criteria (improvement from baseline) 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.
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End point type |
Secondary
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End point timeframe |
Week 36
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| Notes [10] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants Achieving ACR20 Response at Week 48 | ||||||||
End point description |
Response defined by ACR20 criteria (improvement from baseline) 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.
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End point type |
Secondary
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End point timeframe |
Week 48
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| Notes [11] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants Achieving ACR20 Response at Week 52 | ||||||||
End point description |
Response defined by ACR20 criteria (improvement from baseline) 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.
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End point type |
Secondary
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End point timeframe |
Week 52
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| Notes [12] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
Health Assessment Questionnaire Disability Index (HAQ-Dl): Change From Baseline (in the Lead-in Study) to Week 0 | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 0
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| Notes [13] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 4 | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 4
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| Notes [14] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 12 | ||||||||
End point description |
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 the last non missing pre-treatment observation prior to first dose in the lead-in study.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 12
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| Notes [15] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 24 | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 24
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| Notes [16] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 36 | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 36
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| Notes [17] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 48 | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 48
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| Notes [18] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 52 | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 52
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| Notes [19] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
Short Form Health Survey 36 (SF-36) Physical Component Summary (PCS) Score: Change From Baseline (in the Lead-in Study) to Week 0 | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 0
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| Notes [20] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 4 | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 4
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| Notes [21] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 12 | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 12
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| Notes [22] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 24 | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 24
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| Notes [23] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 36 | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 36
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| Notes [24] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 48 | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 48
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| Notes [25] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 52 | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 52
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| Notes [26] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
SF-36 Mental Component Summary (MCS) Score: Change From Baseline (in the Lead-in Study) to Week 0 | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 0
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| Notes [27] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 4 | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 4
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| Notes [28] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 12 | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Baseline (Lead-in Study), Week 12
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| Notes [29] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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End point title |
SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 24 | ||||||||
End point description |
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.
|
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End point type |
Secondary
|
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End point timeframe |
Baseline (Lead-in Study), Week 24
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| Notes [30] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
|
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End point title |
SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 36 | ||||||||
End point description |
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.
|
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End point type |
Secondary
|
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End point timeframe |
Baseline (Lead-in Study), Week 36
|
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|
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| Notes [31] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
|
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End point title |
SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 48 | ||||||||
End point description |
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.
|
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End point type |
Secondary
|
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End point timeframe |
Baseline (Lead-in Study), Week 48
|
||||||||
|
|||||||||
| Notes [32] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
|
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End point title |
SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 52 | ||||||||
End point description |
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.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline (Lead-in Study), Week 52
|
||||||||
|
|||||||||
| Notes [33] - Safety Analysis Set |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug in this study until 20 weeks after the last dose of study drug (up to 56 weeks).
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.0
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Reporting groups
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Reporting group title |
RISANKIZUMAB
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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23 May 2018 |
Revisions to the protocol included extending the adverse event collection period and contraception requirement duration from 16 weeks after the last dose of study drug to 20 weeks after the last dose of study drug and adding a follow-up phone call 20 weeks after the last dose of study drug. These changes were made based on the availability of additional data clarifying the risankizumab terminal half-life (t1/2) from 16 weeks to 20 weeks in Investigator's Brochure Edition 3. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
