Platform Study of Targeted Therapies for Adults With Moderately to Severely Active Rheumatoid Arthritis
A Phase 2b, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic inflammatory disease that primarily affects the joints, causing pain, swelling, stiffness, and loss of function. Synovial fibroblasts play a key role in RA pathogenesis, with treatment-refractory patients demonstrating increased numbers of these cells. The goal of this study is to evaluate the safety and effectiveness of ABBV-2294 (a combination of ABBV-722 and upadacitinib) compared to each drug alone in treating moderately to severely active RA. The platform study will measure improvements in disease activity using the American College of Rheumatology (ACR) criteria, changes in disease activity scores, and quality of life measures.
ABBV-2294 is an investigational combination drug being developed for the treatment of moderately to severely active rheumatoid arthritis. This is a Phase 2b, randomized, double-blind platform study. In sub-study 1, participants are placed in 1 of 5 groups, called treatment arms. Each group receives a different treatment consisting of either ABBV-722 alone, upadacitinib alone, or various doses of ABBV-722 combined with upadacitinib. Adult participants with a diagnosis of moderately to severely active rheumatoid arthritis who have failed at least 1 prior biologic disease-modifying antirheumatic drug (bDMARD) will be enrolled. Around 250 participants will be enrolled in the study at multiple sites worldwide.
Participants will receive oral tablet doses of ABBV-2294 (combination of ABBV-722 and upadacitinib), ABBV-722 alone, or upadacitinib alone. The study comprises a 24-week Double-Blind Phase (Period 1) followed by an optional 52-week Blinded Long Term Extension Phase (Period 2), for a total treatment duration of up to 76 weeks. After completing treatment, participants will have a 30-day Follow-Up Period.
Participants will attend regular visits during the study at a hospital or clinic, including screening, baseline, and scheduled visits through Week 76, followed by a follow-up visit. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：ABBVIE CALL CENTER
- 电话号码：844-663-3742
- 邮箱：abbvieclinicaltrials@abbvie.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Documented clinical diagnosis of RA for >= 3 months and fulfills 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for Rheumatoid arthritis
- No clinically significant medical conditions that would interfere with study participation or compromise participant safety
- Willing and able to comply with procedures required in this Master Protocol and all actively enrolling substudies
- Female participants who are not pregnant or breastfeeding, with negative pregnancy tests at Screening and Baseline
Exclusion Criteria:
- Development of a major cardiovascular event (e.g., acute myocardial infarction, stroke) while on study treatment
- Serious infection (e.g., sepsis) which cannot be adequately controlled by anti-infective treatment
- Confirmed diagnosis of deep vein thrombosis, pulmonary embolus or arterial thrombosis
- Development of active tuberculosis at any time during the study
- Development of any malignancy except localized non-melanoma skin cancer or carcinoma in situ of the cervix
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：ABBV-2294 Dose A
Participants will receive co-administration of ABBV-722 and upadacitinib |
Oral Tablet Oral Tablet |
|
实验性的：ABBV-2294 Dose B
Participants will receive co-administration of ABBV-722 and upadacitinib |
Oral Tablet Oral Tablet |
|
实验性的：ABBV-2294 Dose C
Participants will receive co-administration of ABBV-722 and upadacitinib |
Oral Tablet Oral Tablet |
|
实验性的：ABBV-722 Monotherapy
Participants will receive ABBV-722. At Week 12, participants will then be blindly switched to co-administration of ABBV-722 and upadacitinib. |
Oral Tablet |
|
有源比较器：Upadacitinib Monotherapy
Participants will receive upadacitinib. |
Oral Tablet |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants Achieving ACR50 Response
大体时间：Week 12
|
The ACR50 response is defined as at least 50% improvement in the American College of Rheumatology (ACR) criteria for rheumatoid arthritis. The ACR50 response requires at least 50% improvement in tender and swollen joint counts and at least 50% improvement in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function (HAQ-DI), and acute phase reactant (CRP or ESR). |
Week 12
|
|
Number of Participants Experiencing Adverse Events
大体时间：Up to 80 Weeks
|
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
Up to 80 Weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants Achieving ACR20 Response
大体时间：Week 12
|
ACR20 response is defined as at least 20% improvement from Baseline in the American College of Rheumatology (ACR) core criteria, which includes tender joint count, swollen joint count, patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function, and acute phase reactant (C-reactive protein or erythrocyte sedimentation rate). |
Week 12
|
|
Percentage of Participants Achieving ACR70 Response
大体时间：Week 12
|
ACR70 response is defined as at least 70% improvement from Baseline in the American College of Rheumatology (ACR) core criteria, which includes tender joint count, swollen joint count, patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function, and acute phase reactant (C-reactive protein or erythrocyte sedimentation rate). |
Week 12
|
|
Percentage of Participants Achieving Low Disease Activity Based on DAS28 (CRP) <= 3.2
大体时间：Week 12
|
Low Disease Activity (LDA) is defined as a Disease Activity Score 28 using C-reactive protein (DAS28 [CRP]) of <= 3.2. DAS28 (CRP) is a composite score derived from tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and C-reactive protein. Scores range from 0 to approximately 10, with higher scores indicating more disease activity. |
Week 12
|
|
Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) < 2.6
大体时间：Week 12
|
Clinical Remission (CR) is defined as a Disease Activity Score 28 using C-reactive protein (DAS28 [CRP]) of < 2.6. DAS28 (CRP) is a composite score derived from tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and C-reactive protein. Scores range from 0 to approximately 10, with higher scores indicating more disease activity. |
Week 12
|
|
Percentage of Participants with a Change From Baseline in DAS28 (CRP)
大体时间：Baseline to Week 12
|
Disease Activity Score 28 using C-reactive protein (DAS28 [CRP]) is a composite score derived from tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and C-reactive protein. Scores range from 0 to approximately 10, with higher scores indicating more disease activity. A negative change from Baseline indicates improvement. |
Baseline to Week 12
|
|
Percentage of Participants Achieving Low Disease Activity Based on Clinical Disease Activity Index (CDAI) <= 10
大体时间：Week 12
|
Low Disease Activity (LDA) is defined as a Clinical Disease Activity Index (CDAI) of <= 10. CDAI is a composite score derived from tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76, with higher scores indicating more disease activity. |
Week 12
|
|
Percentage of Participants Achieving Clinical Remission Based on CDAI <= 2.8
大体时间：Week 12
|
Clinical Remission (CR) is defined as a Clinical Disease Activity Index (CDAI) of <= 2.8. CDAI is a composite score derived from tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76, with higher scores indicating more disease activity. |
Week 12
|
合作者和调查者
赞助
调查人员
- 研究主任：ABBVIE INC.、AbbVie
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- M26-032
- 2026-526301-15-00 (克蒂斯)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
IPD 共享时间框架
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD 共享访问标准
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.