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Trial record 1 of 1 for:    NCT02986373
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A Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study 1311.5

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ClinicalTrials.gov Identifier: NCT02986373
Recruitment Status : Completed
First Posted : December 8, 2016
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is an open-label extension (OLE) study to assess the efficacy, safety and tolerability of risankizumab in subjects with psoriatic arthritis (PsA) who have completed all doses of study drug and the Week 24 visit of Study 1311.5 (Phase 2 randomized control trial in PsA subjects, sponsored by Boehringer Ingelheim).

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Biological: risankizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 1311.5
Actual Study Start Date : December 15, 2016
Actual Primary Completion Date : July 8, 2018
Actual Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Risankizumab
Open-label risankizumab
Biological: risankizumab
Risankizumab administered by subcutaneous injection.
Other Names:
  • ABBV-066
  • BI 655066




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 56 weeks ]

Secondary Outcome Measures :
  1. Change from Baseline in Modified Total Sharp Score (mTSS) [ Time Frame: 48 weeks ]
    The mTSS method, which assesses joint space narrowing and erosions, will be used to evaluate radiographic evidence of joint damage.

  2. American College of Rheumatology 20 Response (ACR20) [ Time Frame: 52 weeks ]

    ACR20 is defined as

    • At least 20% improvement in Swollen Joint Count compared to baseline AND
    • At least 20% improvement in Tender Joint Count compared to baseline AND
    • At least 20% improvement in at least 3 out of the following 5 variables

      1. Patient's Assessment of 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)
      5. Serum high-sensitivity C-reactive protein (serum hs-CRP)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have completed all doses of study drug and Week 24 visit of Study 1311.5.
  • 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).
  • Subjects 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.
  • Subject is judged to be in good health as determined by the Investigator.

Exclusion Criteria:

  • Female subject 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 Study 1311.5 for any reason.
  • Use of a biologic treatment other than risankizumab since first dose of study drug in Study 1311.5.
  • Time elapsed is > 8 weeks since the Week 24 visit in Study 1311.5.
  • Active systemic infections during the last 2 weeks (exception: common cold) prior to the first dose, as assessed by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986373


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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02986373     History of Changes
Other Study ID Numbers: M16-244
2016-003113-94 ( EudraCT Number )
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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

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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

Keywords provided by AbbVie:
risankizumab
ABBV-066
BI655066

Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs