A Phase 2, Multicenter Open-Label Extension (OLE) Study With ABT-122 in Active Psoriatic Arthritis Subjects Who Have Completed a Preceding Study M14-197
NCT ID: NCT02429895
Last Updated: 2016-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
168 participants
INTERVENTIONAL
2015-10-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All subjects (open-label extension)
All subjects will start treatment with ABT-122
ABT-122
Injection
Interventions
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ABT-122
Injection
Eligibility Criteria
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Inclusion Criteria
2. If female, subject must meet one of the following criteria:
* Postmenopausal (defined as no menses for at least 1 year).
* Surgically sterile (bilateral oophorectomy or hysterectomy)
If subject does not meet one of the above two categories, subject must use one of the following methods of birth control, from the time of the first dose of study drug until 150 days after the last dose of study drug:
* Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation started at least 2 months prior to the first dose of study drug: oral, intravaginal or transdermal
* Progestogen-only hormonal contraception associated with inhibition of ovulation started at least two months prior to randomization: oral, injectable, or implantable
* Intrauterine device (IUD)
* Intrauterine hormone-releasing system (IUS)
* Bilateral tubal occlusion/ligation
* Be with a vasectomized partner (procedure at least 6 months earlier, the vasectomized male partner should be your sole partner)
* Sexual abstinence (refraining from heterosexual intercourse during the entire study period)
3. If male, subject must be surgically sterile (have had a vasectomy more than 6 months prior to Screening) or must be practicing at least 1 of the following methods of birth control from the time of the first dose of study drug until 150 days post last dose of study drug:
* Subject using condom and female partner(s) using an intrauterine device (IUD);
* Subject using condom and female partner(s) using hormonal contraceptives (oral, vaginal, parenteral or transdermal);
* Subject using condom and female partner(s) using double-barrier method (contraceptive sponge; diaphragm or vaginal ring with spermicidal jellies, creams, or spermicide);
* Total abstinence from sexual intercourse as the preferred lifestyle of the subject; periodic abstinence is not acceptable.
* Subject must also agree to not donate sperm starting on the first day of study drug administration until 150 days after the last dose of study drug.
4. 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.
5. Subject is judged to be in good health as determined by the Investigator.
Exclusion Criteria
2. Ongoing infections at Day 1 (Week 0) that have NOT been successfully treated within 14 days.
3. Anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug.
4. Current enrollment in another investigational study; with the exception of Study M14-197, which is required.
5. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to continue to receive ABT-122.
18 Years
99 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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Heikki T Mansikka, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 138922
Woolloongabba, , Australia
Site Reference ID/Investigator# 138925
Plovdiv, , Bulgaria
Site Reference ID/Investigator# 138926
Plovdiv, , Bulgaria
Site Reference ID/Investigator# 138927
Plovdiv, , Bulgaria
Site Reference ID/Investigator# 138928
Sofia, , Bulgaria
Site Reference ID/Investigator# 138930
Sofia, , Bulgaria
Site Reference ID/Investigator# 138929
Sofia, , Bulgaria
Site Reference ID/Investigator# 138934
Prague, , Czechia
Site Reference ID/Investigator# 138933
Prague, , Czechia
Site Reference ID/Investigator# 138932
Uherské Hradiště, , Czechia
Site Reference ID/Investigator# 141365
Frankfurt, , Germany
Site Reference ID/Investigator# 138953
Lübeck, , Germany
Site Reference ID/Investigator# 138959
Budapest, , Hungary
Site Reference ID/Investigator# 138983
Ādaži, , Latvia
Site Reference ID/Investigator# 138985
Riga, , Latvia
Site Reference ID/Investigator# 138982
Riga, , Latvia
Site Reference ID/Investigator# 138984
Valmiera, , Latvia
Site Reference ID/Investigator# 138986
Auckland, , New Zealand
Site Reference ID/Investigator# 138988
Nelson, , New Zealand
Site Reference ID/Investigator# 138987
Newtown, Wellington, , New Zealand
Site Reference ID/Investigator# 139000
Bialystok, , Poland
Site Reference ID/Investigator# 139012
Bydgoszcz, , Poland
Site Reference ID/Investigator# 138999
Elblag, , Poland
Site Reference ID/Investigator# 139007
Katowice, , Poland
Site Reference ID/Investigator# 139006
Krakow, , Poland
Site Reference ID/Investigator# 139005
Lublin, , Poland
Site Reference ID/Investigator# 139026
Oświęcim, , Poland
Site Reference ID/Investigator# 139004
Poznan, , Poland
Site Reference ID/Investigator# 139001
Stalowa Wola, , Poland
Site Reference ID/Investigator# 139011
Szczecin, , Poland
Site Reference ID/Investigator# 139003
Torun, , Poland
Site Reference ID/Investigator# 139010
Wroclaw, , Poland
Site Reference ID/Investigator# 139013
Bucharest, , Romania
Site Reference ID/Investigator# 139016
Targu-Mures, Jud. Mures, , Romania
Site Reference ID/Investigator# 139022
Elche, , Spain
Site Reference ID/Investigator# 139020
Santiago de Compostela, , Spain
Countries
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References
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Genovese MC, Weinblatt ME, Mease PJ, Aelion JA, Peloso PM, Chen K, Li Y, Liu J, Othman AA, Khatri A, Mansikka HT, Leszczynski P. Dual inhibition of tumour necrosis factor and interleukin-17A with ABT-122: open-label long-term extension studies in rheumatoid arthritis or psoriatic arthritis. Rheumatology (Oxford). 2018 Nov 1;57(11):1972-1981. doi: 10.1093/rheumatology/key173.
Other Identifiers
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2014-005527-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M14-198
Identifier Type: -
Identifier Source: org_study_id
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