EUCTR2015-003376-75-ES进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? Adult male or female, at least 18 years old.
- •? Diagnosis of RA for ? 3 months.
- •? Subjects must have been on oral or parenteral MTX therapy ? 3 months and on a stable dose for ? 4 weeks prior to Screening.
- •? Must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (other than MTX) ? 4 weeks prior to first dose of study drug.
- •? Meets the following minimum disease activity criteria: ? 6 swollen joints (based on 66 joint counts) and ? 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
- •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 465
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 135
排除标准
- •? Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- •? Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).
- •? History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
研究者
相似试验
进行中（未招募）
1 期
A Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(ies) (KEEPsAKE 2)MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Psoriatic arthritisEUCTR2017-002464-40-HUAbbVie Deutschland GmbH & Co. KG420
进行中（未招募）
1 期
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)Moderately to Severely Active Rheumatoid Arthritis (RA)MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2015-003333-95-BGAbbVie Deutschland GmbH & Co. KG1,500
进行中（未招募）
1 期
A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)EUCTR2015-003332-13-CZAbbVie Deutschland GmbH & Co. KG600
进行中（未招募）
1 期
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)EUCTR2015-003333-95-IEAbbVie Deutschland GmbH & Co. KG1,500
进行中（未招募）
1 期
A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)Moderately to Severely Active Rheumatoid Arthritis (RA)MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2015-003335-35-GRAbbVie Deutschland GmbH & Co. KG450