NCT03320876终止2 期
A Multicenter, Open-label, Long-term Extension Safety and Efficacy Study of Filgotinib Treatment in Subjects With Moderately to Severely Active Psoriatic Arthritis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Galapagos NV
- 入组人数
- 122
- 试验地点
- 25
- 主要终点
- Change in the proportion of subjects with adverse events
研究概览
简要总结
This is a Phase 2, multicenter, open-label, single arm, Long Term Extension (LTE) safety, tolerability and efficacy study of filgotinib in subjects with moderately to severely active PsA. It is estimated that approximately 105 subjects will be rolled-over after they have completed the 16 weeks of double-blind treatment in core study GLPG0634-CL-224. Subjects will be administered filgotinib in this study until filgotinib is registered for PsA or until Week 304, whichever occurs first. The LTE study is concluded with a follow-up visit approximately 4 weeks after the last intake of study treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects who are ≥18 years of age, having completed the 16 weeks of treatment in the qualifying core study GLPG0634-CL-224 and who may benefit from filgotinib long-term treatment according to the investigator's judgment.
- •Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to continue to use highly effective methods of contraception as described in the protocol.
- •Able and willing to sign the informed consent form (ICF), as approved by the Independent Ethics Committee (IEC) and agree to the schedule of assessments.
排除标准
- •Subjects who are deemed not to be benefitting from the study drug based upon lack of improvement or worsening of their symptoms. Local guidelines for subject treatment need to be followed.
- •Persistent abnormal laboratory values associated with the use of the study drug (including and not limited to hematology, liver and renal function values), according to the investigator's clinical judgment.
- •Subjects who discontinued the qualifying core study GLPG0634-CL-224 due to safety or tolerability issues.
- •Subjects who require immunization with live/live attenuated vaccine.
- •Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than psoriatic arthritis, except for Sjögren's syndrome.
- •Subjects with symptoms suggestive of uncontrolled hypertension, congestive heart failure, uncontrolled diabetes, cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia or any other cardiovascular condition since the inclusion to the GLPG0634- CL-224 study.
- •Subjects with symptoms suggestive of gastrointestinal tract ulceration and/or active diverticulitis since the inclusion to the GLPG0634-CL-224 study.
- •Subjects with symptoms suggestive of possible lymphoproliferative disease including lymphadenopathy or splenomegaly since the inclusion to the GLPG0634-CL-224 study.
- •Subjects with symptoms suggestive of malignancy since the inclusion to the GLPG0634-CL-224 study.
研究组 & 干预措施
filgotinib
Experimental
干预措施: filgotinib (Drug)
结局指标
主要结局
Change in the proportion of subjects with adverse events
时间窗: Between entry visit and 4 weeks after the last dose.
To asses safety and tolerability of filgotinib.
次要结局
- Proportion of subjects achieving ACR50 response(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Proportion of subjects achieving ACR70 response(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Proportion of subjects achieving minimal disease activity (MDA)(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Proportion of subjects achieving American College of Rheumatology 20 (ACR20) response(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Proportion of subjects with Psoriatic Arthritis Disease Activity Score (PASDAS) low disease activity (LDA, i.e. PASDAS ≤ 3.2)(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Proportion of subjects with PASDAS Very Low Disease Activity (VLDA) (i.e. PASDAS ≤1.9)(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Percentage of patients subjects with PASDAS VLDA (i.e. PASDAS ≤1.9)(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Proportion of subjects with DAPSA remission (DAPSA ≤4)(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Proportion of subjects with PASI90(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Percentage of patients subjects with PASDAS LDA (i.e. PASDAS ≤3.2)(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Change from core baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA)(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Proportion of subjects with DAPSA remission/LDA (DAPSA ≤14)(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Change from core baseline in Psoriasis Area and Severity Index (PASI)(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Proportion of subjects with PASI50(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Proportion of subjects with PASI75(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Change from core baseline in Patient's Global Assessment of psoriasis(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Change from core baseline in modified Nail Psoriasis Area and Severity Index (mNAPSI)(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Change from core baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Change from baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue scale)(W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.)
- Change from core baseline in individual components of the ACR response of improvement in multiple disease assessment criteria(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Proportion of subjects with PASI100(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Change from core baseline in Psoriatic Arthritis Impact of Disease Questionnaire (PsAID).(W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.)
- Change from core baseline in Physician's global assessment of psoriasis(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Change from core baseline in 36-item Short-Form Health Survey (SF-36)(W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.)
- Change from core baseline in pruritis numeric rating scale (NRS)(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Proportion of subjects achieving a pruritis numeric rating scale (NRS) response(improvement in pruritus NRS score of ≥3)(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Change from core baseline in Leeds Dactylitis Index (LDI)(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
- Change from core baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)(At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.)
研究者
研究点 (25)
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