Register a trial

Please note that the ANZCTR website will be unavailable from 1:00pm until 2:00pm (AEST) on Thursday 10th of April for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.


The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03104374




Registration number
NCT03104374
Ethics application status
Date submitted
4/04/2017
Date registered
7/04/2017

Titles & IDs
Public title
A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug
Scientific title
A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)
Secondary ID [1] 0 0
2016-004152-30
Secondary ID [2] 0 0
M15-554
Universal Trial Number (UTN)
Trial acronym
SELECT - PsA 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - ABT-494

Experimental: ABT-494 Dose A - It is administered once daily.

Placebo comparator: Placebo followed by ABT-494 Dose B - It is administered once daily.

Experimental: ABT-494 Dose B - It is administered once daily.

Placebo comparator: Placebo followed by ABT-494 Dose A - It is administered once daily.


Treatment: Drugs: Placebo
Oral tablet

Treatment: Drugs: ABT-494
Oral tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Assessment method [1] 0 0
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. = 20% improvement in 68-tender joint count; 2. = 20% improvement in 66-swollen joint count; and 3. = 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Assessment method [1] 0 0
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16
Assessment method [2] 0 0
The sIGA is a 5 point scale ranging from 0 to 4, based on the investigator's assessment of the average elevation, erythema, and scaling of all psoriatic lesions at the current visit. A lower score indicates less severe psoriasis (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe).
Timepoint [2] 0 0
Baseline and Week 16
Secondary outcome [3] 0 0
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16
Assessment method [3] 0 0
PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked). The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from Baseline in PASI score.
Timepoint [3] 0 0
Baseline and Week 16
Secondary outcome [4] 0 0
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
Assessment method [4] 0 0
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [5] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
Assessment method [5] 0 0
The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 'not at all' to 4 'very much'. The FACIT Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.
Timepoint [5] 0 0
Baseline and Week 12
Secondary outcome [6] 0 0
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
Assessment method [6] 0 0
A participant was classified as achieving MDA if 5 of the following 7 criteria were met: * Tender joint count (out of 68 joints) = 1 * Swollen joint count (out of 66 joints) = 1 * PASI score = 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis = 3% * Patient's assessment of pain = 1.5 (NRS from 0 to 10) * Patient's Global Assessment of disease activity = 2 (NRS from 0 to 10) * HAQ-DI score = 0.5 (index score ranges from 0 to 3) * Leeds Enthesitis Index = 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, with an overall score range from 0 to 6)
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Score at Week 16
Assessment method [7] 0 0
The SAPS is an 11-item self-assessment of psoriasis symptoms that includes questions on: pain, itching, redness, scaling, flaking, bleeding, burning, stinging, tenderness, pain due to skin cracking, and joint pain. Each item is scored from 0 to 10, with 0 being least severe and 10 being most severe. The total score is generated by summing the 11 items and ranges from 0 to 110 (worst). A negative change from Baseline in the total score indicates improvement.
Timepoint [7] 0 0
Baseline and Week 16
Secondary outcome [8] 0 0
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Assessment method [8] 0 0
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. = 50% improvement in 68-tender joint count; 2. = 50% improvement in 66-swollen joint count; and 3. = 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Timepoint [8] 0 0
Baseline and Week 12
Secondary outcome [9] 0 0
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
Assessment method [9] 0 0
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: 1. = 70% improvement in 68-tender joint count; 2. = 70% improvement in 66-swollen joint count; and 3. = 70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Timepoint [9] 0 0
Baseline and Week 12
Secondary outcome [10] 0 0
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2
Assessment method [10] 0 0
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. = 20% improvement in 68-tender joint count; 2. = 20% improvement in 66-swollen joint count; and 3. = 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Timepoint [10] 0 0
Baseline and Week 2

Eligibility
Key inclusion criteria
* Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria
* Participant has active disease at Baseline defined as >= 3 tender joints (based on 68 joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
* Diagnosis of active plaque psoriasis or documented history of plaque psoriasis
* Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) or intolerance to treatment with at least 1 bDMARD.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib)
* Current treatment with > 2 non-biologic DMARDs or use of DMARDs other than Methotrexate (MTX), Sulfasalazine (SSZ), Leflunomide (LEF), apremilast, Hydroxychloroquine (HCQ), bucillamine or iguratimod or use of MTX in combination with LEF at Baseline.
* History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2024
Sample size
Target
Accrual to date
Final
642
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Emeritus Research Sydney /ID# 166751 - Botany
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital /ID# 200840 - Woodville South
Recruitment hospital [3] 0 0
Box Hill Hospital /ID# 166752 - Box Hill
Recruitment hospital [4] 0 0
Heidelberg Repatriation Hospital /ID# 167441 - Heidelberg West
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3081 - Heidelberg West
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New Mexico
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
North Dakota
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
Belgium
State/province [27] 0 0
Limburg
Country [28] 0 0
Belgium
State/province [28] 0 0
Oost-Vlaanderen
Country [29] 0 0
Brazil
State/province [29] 0 0
Goias
Country [30] 0 0
Brazil
State/province [30] 0 0
La Spezia
Country [31] 0 0
Brazil
State/province [31] 0 0
Minas Gerais
Country [32] 0 0
Brazil
State/province [32] 0 0
Rio Grande Do Sul
Country [33] 0 0
Brazil
State/province [33] 0 0
Sao Paulo
Country [34] 0 0
Canada
State/province [34] 0 0
British Columbia
Country [35] 0 0
Canada
State/province [35] 0 0
Manitoba
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
Chile
State/province [38] 0 0
Aisen Del General Carlos Ibanez Del Campo
Country [39] 0 0
Chile
State/province [39] 0 0
Santiago
Country [40] 0 0
Czechia
State/province [40] 0 0
Prostejov
Country [41] 0 0
Czechia
State/province [41] 0 0
Uherske Hradiste
Country [42] 0 0
France
State/province [42] 0 0
Bouches-du-Rhone
Country [43] 0 0
France
State/province [43] 0 0
Occitanie
Country [44] 0 0
France
State/province [44] 0 0
Sarthe
Country [45] 0 0
France
State/province [45] 0 0
Chambray Les Tours
Country [46] 0 0
France
State/province [46] 0 0
Creteil
Country [47] 0 0
France
State/province [47] 0 0
Paris
Country [48] 0 0
Greece
State/province [48] 0 0
Attiki
Country [49] 0 0
Greece
State/province [49] 0 0
Athens
Country [50] 0 0
Greece
State/province [50] 0 0
Larisa
Country [51] 0 0
Hungary
State/province [51] 0 0
Gyor-Moson-Sopron
Country [52] 0 0
Hungary
State/province [52] 0 0
Veszprem
Country [53] 0 0
Hungary
State/province [53] 0 0
Budapest
Country [54] 0 0
Hungary
State/province [54] 0 0
Debrecen
Country [55] 0 0
Hungary
State/province [55] 0 0
Szolnok
Country [56] 0 0
Italy
State/province [56] 0 0
L Aquila
Country [57] 0 0
Italy
State/province [57] 0 0
Roma
Country [58] 0 0
Italy
State/province [58] 0 0
Ancona
Country [59] 0 0
Italy
State/province [59] 0 0
Catania
Country [60] 0 0
Italy
State/province [60] 0 0
Cona
Country [61] 0 0
Italy
State/province [61] 0 0
Milan
Country [62] 0 0
Italy
State/province [62] 0 0
Reggio Emilia
Country [63] 0 0
Japan
State/province [63] 0 0
Aichi
Country [64] 0 0
Japan
State/province [64] 0 0
Fukuoka
Country [65] 0 0
Japan
State/province [65] 0 0
Hokkaido
Country [66] 0 0
Japan
State/province [66] 0 0
Mie
Country [67] 0 0
Japan
State/province [67] 0 0
Miyagi
Country [68] 0 0
Japan
State/province [68] 0 0
Oita
Country [69] 0 0
Japan
State/province [69] 0 0
Osaka
Country [70] 0 0
Japan
State/province [70] 0 0
Tokyo
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Gyeonggido
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Incheon Gwang Yeogsi
Country [73] 0 0
Netherlands
State/province [73] 0 0
Zuid-Holland
Country [74] 0 0
Netherlands
State/province [74] 0 0
Ubbergen
Country [75] 0 0
New Zealand
State/province [75] 0 0
Auckland
Country [76] 0 0
New Zealand
State/province [76] 0 0
Canterbury
Country [77] 0 0
New Zealand
State/province [77] 0 0
Waikato
Country [78] 0 0
New Zealand
State/province [78] 0 0
Nelson
Country [79] 0 0
Portugal
State/province [79] 0 0
Porto
Country [80] 0 0
Portugal
State/province [80] 0 0
Viana Do Castelo
Country [81] 0 0
Portugal
State/province [81] 0 0
Lisboa
Country [82] 0 0
Puerto Rico
State/province [82] 0 0
Carolina
Country [83] 0 0
Puerto Rico
State/province [83] 0 0
Ponce
Country [84] 0 0
Puerto Rico
State/province [84] 0 0
San Juan
Country [85] 0 0
Spain
State/province [85] 0 0
Murcia
Country [86] 0 0
Spain
State/province [86] 0 0
A Coruna
Country [87] 0 0
Spain
State/province [87] 0 0
Cordoba
Country [88] 0 0
Spain
State/province [88] 0 0
Granada
Country [89] 0 0
Spain
State/province [89] 0 0
Madrid
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Bath And North East Somerset
Country [91] 0 0
United Kingdom
State/province [91] 0 0
London, City Of
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Glasgow
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Luton
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Poole

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03104374