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)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 168
- 试验地点
- 36
- 主要终点
- American College of Rheumatology (ACR) 20 response rate by visit
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have completed preceding Study M14-197 (ABT-122) RCT study and have not developed any discontinuation criteria of Study M14-
- •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)
- •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.
- •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.
- •Subject is judged to be in good health as determined by the Investigator.
排除标准
- •Pregnant or breastfeeding or plans to become pregnant during study participation.
- •Ongoing infections at Day 1 (Week 0) that have NOT been successfully treated within 14 days.
- •Anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug.
- •Current enrollment in another investigational study; with the exception of Study M14-197, which is required.
- •Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to continue to receive ABT-122.
研究组 & 干预措施
All subjects (open-label extension)
All subjects will start treatment with ABT-122
干预措施: ABT-122 (Drug)
结局指标
主要结局
American College of Rheumatology (ACR) 20 response rate by visit
时间窗: From Week 0 to Week 24
ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.
American College of Rheumatology (ACR) 50 response rate by visit
时间窗: From Week 0 to Week 24
ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.
American College of Rheumatology (ACR) 70 response rate by visit
时间窗: From Week 0 to Week 24
ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.
Change in American College of Rheumatology (ACR) the individual component by visit
时间窗: From Week 0 to Week 24
ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.
Change in Disease Activity Score DAS28 [hsCRP] by visit
时间窗: From Week 0 to Week 24
Determine by disease activity score using 28 joint counts (DAS28) and high-sensitivity C-reactive protein (hsCRP) lab test.
Change in Psoriatic Disease Activity Score (PASDAS) by visit
时间窗: From Week 0 to Week 24
PASDAS determined by tender or swollen joint counts, patient reported outcome and hsCRP lab test.
Change in Psoriasis Area and Severity Index (PASI) by visit
时间窗: From Week 0 to Week 24
Determined by scores for the amount and severity of a patient's psoriasis.
Change in Psoriasis Target Lesion Score by visit
时间窗: From Week 0 to Week 24
Determined by plaque erythema, plaque scaling and plaque thickness scores.
Change in Dactylitis Assessment by visit
时间窗: From Week 0 to Week 24
Determined by presence of dactylitis, swelling, and tenderness in each digit of both hands and both feet.
Change in Enthesitis Sites Comprising the Total Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index by visit
时间窗: From Week 0 to Week 24
Determined by the presence and severity of enthesitis.
Change in Self-Assessment of Psoriasis Symptoms (SAPS) by visit
时间窗: From Week 0 to Week 24
Determined by scores given by patients regarding the severity of their psoriatic symptoms.
Change in skin biopsy/biomarkers
时间窗: From Week 0 to Week 24
Optional samples to assess changes related on disease activity/prognosis of psoriatic arthritis (PsA), autoimmunity/inflammation, and/or response to anti-PsA medications.
Change in the quality of life, function and work as measured by the Short-Form Health Survey Version 2.0 (SF36v2) by visit
时间窗: From Week 0 to Week 24
Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.
Change in the quality of life, function and work as measured by Bath AS Disease Activity Index (BASDAI) by visit
时间窗: From Week 0 to Week 24
Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.
Change in the quality of life, function and work as measured by the Fatigue Numeric Rating Scale by visit
时间窗: From Week 0 to Week 24
Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.
Change in the quality of life, function and work as measured by the Sleep Quality Scale by visit
时间窗: From Week 0 to Week 24
Quality of life are self reported measures to assess the physical function of the patient and how their activities are impacted by their disease.
次要结局
未报告次要终点