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A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675308
Recruitment Status : Active, not recruiting
First Posted : September 18, 2018
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE September 12, 2018
First Posted Date  ICMJE September 18, 2018
Last Update Posted Date May 12, 2020
Actual Study Start Date  ICMJE March 25, 2019
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2020)
Percentage of Participants Achieving at least 20% Improvement in American College of Rheumatology (ACR20) at Week 24 [ Time Frame: Week 24 ]
ACR20 is defined as at least 20% improvement in swollen joint count, tender joint count, and at least 3 out of the following 5 variables: 1) Patient's Assessment of psoriatic arthritis (PsA) Pain Intensity visual analog scale (VAS), 2) Patient's Global Assessment of Disease VAS, 3) Physician's Global Assessment of Disease Activity VAS, 4) Patient's Assessment of Disability on Health Assessment Questionnaire Disability Index (HAQ-DI), and 5) Serum high-sensitivity C-reactive protein (serum hs-CRP).
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2018)
Percentage of Participants Achieving at least 20% Improvement in American College of Rheumatology (ACR20) at Week 24 [ Time Frame: Baseline, Week 24 ]
ACR20 is defined as at least 20% improvement in swollen joint count, tender joint count, and at least 3 out of the following 5 variables: 1) Patient's Assessment of psoriatic arthritis (PsA) Pain Intensity visual analog scale (VAS), 2) Patient's Global Assessment of Disease VAS, 3) Physician's Global Assessment of Disease Activity VAS, 4) Patient's Assessment of Disability on Health Assessment Questionnaire Disability Index (HAQ-DI), and 5) Serum high-sensitivity C-reactive protein (serum hs-CRP).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2020)
  • Change In Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Week 24 ]
    The HAQ-DI is a self-reported questionnaire of how the patient's illness affects their ability to function in their daily life over the past week.
  • Percentage Of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response (In The Subset Of Participants With A Body Surface Area [BSA] >= 3% At Baseline) [ Time Frame: Week 24 ]
    PASI 90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity.
  • Change in modified Total Sharp Score (PsA-mTSS) [ Time Frame: Week 24 ]
    The modified PsA-mTSS method is used to evaluate radiographic evidence of damage.
  • Percentage of Participants Achieving Minimal Disease Activity (MDA) [ Time Frame: Week 24 ]
    The percentage of participants who achieve MDA.
  • Change in Fingernail Psoriasis [ Time Frame: Week 24 ]
    Fingernail psoriasis will be evaluated using either the Physician Global Assessment - Fingernails (PGA-F) or the modified Nail Psoriasis Severity Index (mNAPSI), depending on location.
  • Percentage Of Participants With Resolution Of Enthesitis (Leeds Enthesitis Index [LEI] = 0) In Participants with Enthesitis at Baseline [ Time Frame: Week 24 ]
    The LEI will be used to assess the presence or absence of enthesitis.
  • Percentage Of Participants With Resolution Of Dactylitis (LDI = 0) In Participants With Dactylitis at Baseline [ Time Frame: Week 24 ]
    The LDI will be used to assess the presence or absence of dactylitis.
  • Change In 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) [ Time Frame: Week 24 ]
    The SF-36 is a 36-item, general health, self-administered questionnaire.
  • Change In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaire [ Time Frame: Week 24 ]
    The FACIT-Fatigue is a 13-item questionnaire that evaluates fatigue/tiredness and its impact on daily activities and functioning in chronic diseases.
  • Percentage Of Participants Achieving ACR50 Response [ Time Frame: Week 24 ]
    ACR50 response is defined as at least 50% reduction (improvement) compared with baseline in tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PhGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP).
  • Percentage Of Participants Achieving ACR70 Response [ Time Frame: Week 24 ]
    ACR70 response is defined as at least 70% reduction (improvement) compared with baseline in tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PhGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2018)
  • Change from Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline, Week 24 ]
    The HAQ-DI is a self-reported questionnaire of how the patient's illness affects their ability to function in their daily life over the past week.
  • Percentage of Participants With ≥ 90% Reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 24 in Participants With ≥ 3% Body Surface Area (BSA) Involving Psoriasis at Baseline [ Time Frame: Baseline, Week 24 ]
    PASI 90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity.
  • Change from Baseline to Week 24 in modified Total Sharp Score (PsA-mTSS) at Week 24 [ Time Frame: Baseline, Week 24 ]
    The modified PsA-mTSS method is used to evaluate radiographic evidence of damage.
  • Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24 [ Time Frame: Baseline, Week 24 ]
    The percentage of participants who achieve MDA.
  • Change from Baseline to Week 24 in Fingernail Psoriasis [ Time Frame: Baseline, Week 24 ]
    Fingernail psoriasis will be evaluated using either the Physician Global Assessment - Fingernails (PGA-F) or the modified Nail Psoriasis Severity Index (mNAPSI), depending on location.
  • Change from Baseline to Week 24 in Leeds Enthesitis Index (LEI) in Participants with Enthesitis at Baseline [ Time Frame: Baseline, Week 24 ]
    The LEI will be used to assess the presence or absence of enthesitis.
  • Change from Baseline to Week 24 in Leeds Dactylitis Index (LDI) in Participants With Dactylitis at Baseline [ Time Frame: Baseline, Week 24 ]
    The LDI will be used to assess the presence or absence of dactylitis.
  • Change from Baseline to Week 24 in the 36-Item Short Form Health Questionnaire (SF-36) Physical Component Summary (PCS) Score [ Time Frame: Baseline, Week 24 ]
    The SF-36 is a 36-item, general health, self-administered questionnaire.
  • Change from Baseline to Week 24 in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaire Score [ Time Frame: Baseline, Week 24 ]
    The FACIT-Fatigue is a 13-item questionnaire that evaluates fatigue/tiredness and its impact on daily activities and functioning in chronic diseases.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1)
Brief Summary The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in participants with moderately to severely active psoriatic arthritis (PsA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE
  • Biological: placebo for rizankizumab
    Placebo for risankizumab administered by subcutaneous (SC) injection
  • Biological: risankizumab
    Risankizumab administered by subcutaneous (SC) injection
    Other Names:
    • ABBV-066
    • BI 655066
    • SKYRIZI
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Participants randomized to receive double-blind placebo for 24 weeks (Period 1) followed by open-label risankizumab for 184 weeks (Period 2).
    Interventions:
    • Biological: placebo for rizankizumab
    • Biological: risankizumab
  • Experimental: Risankizumab
    Participants randomized to receive double-blind risankizumab for 24 weeks (Period 1) followed by open-label risankizumab for 184 weeks (Period 2).
    Intervention: Biological: risankizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 8, 2020)
964
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2018)
880
Estimated Study Completion Date  ICMJE July 4, 2024
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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) at the Screening Visit.
  • Participant has active disease at Baseline
  • Diagnosis of active plaque psoriasis.
  • Participant has demonstrated an inadequate response or intolerance to conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).
  • Presence of either at Screening:

    • ≥ 1 erosion on radiograph as determined by central imaging review or;
    • High sensitivity C-Reactive Protein (hsCRP) ≥ 3.0 mg/L.

Exclusion Criteria:

  • Participant is considered by investigator, for any reason, to be an unsuitable candidate for the study.
  • Participant has a known hypersensitivity to risankizumab.
  • Participant has previous treatment with biologic agent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   Canada,   Chile,   Croatia,   Czechia,   Denmark,   Estonia,   Finland,   Germany,   Greece,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries Slovenia
 
Administrative Information
NCT Number  ICMJE NCT03675308
Other Study ID Numbers  ICMJE M16-011
2017-002465-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP