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)
- Conditions
- Psoriatic ArthritisMedDRA version: 18.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2014-005527-27-ES
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 168
1. Subjects who have completed preceding Study M14-197 (ABT-122) RCT study and have not developed any discontinuation criteria, defined in Section 5.4.1 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).
? Total abstinence from sexual intercourse as the preferred lifestyle of the subject. Periodic abstinence is not acceptable.
? Practicing appropriate birth control, from the time of enrollment in this study until at least 150 days after the last dose of study drug defined as at least TWO of the following methods of birth control:
-Tubal ligation
-Partner vasectomy (at least 6 months earlier) (the vasectomized male partner should be the sole partner for that female subject)
-Intrauterine device (IUD)
-Diaphragm, contraceptive sponge or cervical cap with spermicidal jelly or cream
-Hormonal contraceptives (note, low-dose progestin-only oral contraceptives such as norethindrone 0.35 mg and lynestenol 0.5 mg are not considered adequate)
-Double-barrier contraception* defined as: A male condom PLUS diaphragm or cervical cap used with spermicidal jelly or cream.
* Note: A female condom and a male condom should not be used together. Also, because the contraceptive sponge has a high failure rate, particularly in multiparous females, it should not be considered an acceptable alternative.
3. Male who agrees to follow one of the protocol-specified pregnancy avoidance measures below, including refraining from donating sperm, for up to 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); (note, low-dose progestin-only oral contraceptives such as norethindrone 0.35 mg and lynestenol 0.5 mg are not considered adequate);
? 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.
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 based on the results of medical history, physical examination and laboratory profile performed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method