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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
This study is ongoing, but not recruiting participants.
Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02986373
First received: December 6, 2016
Last updated: July 7, 2017
Last verified: July 2017
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Psoriatic Arthritis | Biological: risankizumab | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking 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 |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Adverse Events [ Time Frame: 52 weeks ]
Secondary Outcome Measures:
- 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
- Patient's Assessment of PsA Pain Intensity visual analog scale (VAS)
- Patient's Global Assessment of Disease VAS
- Physician's Global Assessment of Disease Activity VAS
- Patient's Assessment of Disability on Health Assessment Questionnaire Disability Index (HAQ-DI)
- Serum high-sensitivity C-reactive protein (serum hs-CRP)
- 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.
| Estimated Enrollment: | 180 |
| Study Start Date: | December 15, 2016 |
| Estimated Study Completion Date: | October 15, 2018 |
| Estimated Primary Completion Date: | August 25, 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Risankizumab
Open-label risankizumab
|
Biological: risankizumab
Risankizumab administered by subcutaneous injection.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
| 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 16 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 16 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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02986373
Show 40 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02986373
Show 40 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | AbbVie Inc | AbbVie |
More Information
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT02986373 History of Changes |
| Other Study ID Numbers: |
M16-244 2016-003113-94 ( EudraCT Number ) |
| Study First Received: | December 6, 2016 |
| Last Updated: | July 7, 2017 |
Keywords provided by AbbVie:
|
ABBV-066 BI655066 risankizumab |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis |
Spondylitis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on July 17, 2017