Clinical trial NCT02429895: 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
Official title: 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 Phase 2 Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Keywords: Methotrexate
Efficacy
Safety
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-04-29
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 Phase 2 Randomized Controlled Trial (RCT).


Eligibility criteria: Inclusion Criteria:

1. Subjects who have completed preceding Study M14-197 (ABT-122) RCT study and have not developed any discontinuation criteria of Study M14-197.
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:

1. Pregnant or breastfeeding or plans to become pregnant during study participation.
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.

Primary outcomes:
measure: American College of Rheumatology (ACR) 20 response rate by visit
timeFrame: From Week 0 to Week 24
measure: American College of Rheumatology (ACR) 50 response rate by visit
timeFrame: From Week 0 to Week 24
measure: American College of Rheumatology (ACR) 70 response rate by visit
timeFrame: From Week 0 to Week 24
measure: Change in American College of Rheumatology (ACR) the individual component by visit
timeFrame: From Week 0 to Week 24
measure: Change in Disease Activity Score DAS28 [hsCRP] by visit
timeFrame: From Week 0 to Week 24
measure: Change in Psoriatic Disease Activity Score (PASDAS) by visit
timeFrame: From Week 0 to Week 24
measure: Change in Psoriasis Area and Severity Index (PASI) by visit
timeFrame: From Week 0 to Week 24
measure: Change in Psoriasis Target Lesion Score by visit
timeFrame: From Week 0 to Week 24
measure: Change in Dactylitis Assessment by visit
timeFrame: From Week 0 to Week 24
measure: Change in Enthesitis Sites Comprising the Total Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index by visit
timeFrame: From Week 0 to Week 24
measure: Change in Self-Assessment of Psoriasis Symptoms (SAPS) by visit
timeFrame: From Week 0 to Week 24
measure: Change in skin biopsy/biomarkers
timeFrame: From Week 0 to Week 24
measure: Change in the quality of life, function and work as measured by the Short-Form Health Survey Version 2.0 (SF36v2) by visit
timeFrame: From Week 0 to Week 24
measure: Change in the quality of life, function and work as measured by Bath AS Disease Activity Index (BASDAI) by visit
timeFrame: From Week 0 to Week 24
measure: Change in the quality of life, function and work as measured by the Fatigue Numeric Rating Scale by visit
timeFrame: From Week 0 to Week 24
measure: Change in the quality of life, function and work as measured by the Sleep Quality Scale by visit
timeFrame: From Week 0 to Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Woolloongabba
country: Australia
facility: Site Reference ID/Investigator# 138922
city: Plovdiv
country: Bulgaria
facility: Site Reference ID/Investigator# 138925
city: Plovdiv
country: Bulgaria
facility: Site Reference ID/Investigator# 138926
city: Plovdiv
country: Bulgaria
facility: Site Reference ID/Investigator# 138927
city: Sofia
country: Bulgaria
facility: Site Reference ID/Investigator# 138928
city: Sofia
country: Bulgaria
facility: Site Reference ID/Investigator# 138930
city: Sofia
country: Bulgaria
facility: Site Reference ID/Investigator# 138929
city: Praha 4
country: Czech Republic
facility: Site Reference ID/Investigator# 138934
city: Praha
country: Czech Republic
facility: Site Reference ID/Investigator# 138933
city: Uherske Hradiste
country: Czech Republic
facility: Site Reference ID/Investigator# 138932
city: Frankfurt
country: Germany
facility: Site Reference ID/Investigator# 141365
city: Luebeck
country: Germany
facility: Site Reference ID/Investigator# 138953
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 138959
city: Adazi
country: Latvia
facility: Site Reference ID/Investigator# 138983
city: Riga
country: Latvia
facility: Site Reference ID/Investigator# 138985
city: Riga
country: Latvia
facility: Site Reference ID/Investigator# 138982
city: Valmiera
country: Latvia
facility: Site Reference ID/Investigator# 138984
city: Auckland
country: New Zealand
facility: Site Reference ID/Investigator# 138986
city: Nelson
country: New Zealand
facility: Site Reference ID/Investigator# 138988
city: Newtown, Wellington
country: New Zealand
facility: Site Reference ID/Investigator# 138987
city: Bialystok
country: Poland
facility: Site Reference ID/Investigator# 139000
city: Bydgoszcz
country: Poland
facility: Site Reference ID/Investigator# 139012
city: Elblag
country: Poland
facility: Site Reference ID/Investigator# 138999
city: Katowice
country: Poland
facility: Site Reference ID/Investigator# 139007
city: Krakow
country: Poland
facility: Site Reference ID/Investigator# 139006
city: Lublin
country: Poland
facility: Site Reference ID/Investigator# 139005
city: Oswiecim
country: Poland
facility: Site Reference ID/Investigator# 139026
city: Poznan
country: Poland
facility: Site Reference ID/Investigator# 139004
city: Stalowa Wola
country: Poland
facility: Site Reference ID/Investigator# 139001
city: Szczecin
country: Poland
facility: Site Reference ID/Investigator# 139011
city: Torun
country: Poland
facility: Site Reference ID/Investigator# 139003
city: Wroclaw
country: Poland
facility: Site Reference ID/Investigator# 139010
city: Bucuresti
country: Romania
facility: Site Reference ID/Investigator# 139013
city: Targu-Mures, Jud. Mures
country: Romania
facility: Site Reference ID/Investigator# 139016
city: Elche
country: Spain
facility: Site Reference ID/Investigator# 139022
city: Santiago de Compostela
country: Spain
facility: Site Reference ID/Investigator# 139020
Study officials:
affiliation: AbbVie
name: Heikki T Mansikka, MD
role: STUDY_DIRECTOR
References:
citation: 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.