Psoriatic Arthritis MedDRA version: 19.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who have completed all doses of study drug and Week 24 visit of Study 1311.5. 2. 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. Accepted methods of contraception are as follows: ? combined (estrogen and progestogen containing) hormonal birth control (oral, intravaginal, transdermal) associated with inhibition of ovulation initiated at least 1 month prior to study participation ? progestogen-only hormonal birth control associated with inhibition of ovulation, initiated at least 1 month prior to study participation ? bilateral tubal occlusion/ligation ? intrauterine device (IUD) ? intrauterine hormone-releasing system (IUS). ? Subject must have only vasectomized sexual partner(s) ? True abstinence: Refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable). Women of childbearing potential are defined as having experienced menarche and are: ? not postmenopausal (12 months with no menses without an alternative medical cause) and are ? not permanently sterilized (e.g., hysterectomy, bilateral oophorectomy or bilateral salpingectomy). 3. Females of childbearing potential must have a negative urine pregnancy test at Baseline (Week 0/V1). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 155 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. Female subject who is pregnant, breastfeeding or is considering becoming pregnant during study participation, including after the last dose of study drug is given. 2. Premature discontinuation of the treatment in Study 1311.5 for any reason. 3. Use of a biologic treatment other than risankizumab since first dose of study drug in Study 1311.5. 4. Time elapsed is > 8 weeks since the Week 24 visit in Study 1311.5 5. Active systemic infections during the last 2 weeks (exception: common cold) prior to randomization, as assessed by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the safety and tolerability of risankizumab in PsA subjects who have completed all doses of study drug and the Week 24 visit in Study 1311.5.;Secondary Objective: Assess efficacy of risankizumab, and the impact of risankizumab on the inhibition of structural progression, in PsA subjects who completed all doses of study drug and the Week 24 visit in Study 1311.5.;Primary end point(s): Not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? ACR 20 response compared to baseline (from study 1311.5) ? Change in mTSS compared to baseline (from study 1311.5) ; Timepoint(s) of evaluation of this end point: ? Weeks 24 and 48 ? Weeks 24 and 48 | — |
Countries
Belgium, Canada, Czech Republic, European Union, Finland, France, Germany, Japan, Spain, Taiwan, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd
Outcome results
None listed