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: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2014-005527-27-IT
- 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 PLUSdiaphragm 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, lowdose
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 Main Objective: Assess the long term efficacy, and safety and tolerability of ABT-122 in psoriatic arthritis (PsA) subjects on background methotrexate (MTX) who have completed Study M14-197 Phase 2 RCT.;Secondary Objective: -To explore the effect of continued dosing on anti-drug antibody (ADA)<br>profiles for ABT-122.<br>-To explore the longer term effects of ABT-122 on function, quality of life<br>and fatigue.;Primary end point(s): The primary objective of Study M14-198 is to assess the long term efficacy, and the safety and tolerability of ABT-122 in PsA subjects on background methotrexate (MTX) who have completed Study M14-197 Phase2 RCT.;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ¿ To explore the effect of continued dosing on anti-drug antibody (ADA) profiles for ABT-122.<br>¿ To explore the longer term effects of ABT-122 on function, quality of life and fatigue.;Timepoint(s) of evaluation of this end point: Week 24