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Sponsor has concluded that patients are unlikely to derive sufficient benefit from treatment with BGB-45035 to support continuation of the clinical development program due to unfavored benefit/risk profile.
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This study aims to evaluate the efficacy of BGB-45035 in adults with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or biologic disease-modifying antirheumatic drugs (bDMARDs)/targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGB-45035 | Experimental | Participants will receive BGB-45035 orally for up to 12 weeks |
|
| Placebo | Placebo Comparator | Participants will receive placebo orally for up to 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-45035 | Drug | Administered orally |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Disease Activity Score - C-reactive protein (DAS28-CRP) at Week 12 | The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), high-sensitivity C-reactive protein (hsCRP in mg/L), and Patient's Global Assessment of Arthritis Pain (measured on a Visual Analog Scale [VAS] from 0 [no pain] to 100 [worst possible pain]). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A score greater than 5.1 indicates high disease activity, a score between 3.2 and 5.1 indicates moderate disease activity, a score between 2.6 and 3.2 indicates low disease activity, and a score less than 2.6 indicates the participant is in remission. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with a 20% improvement in American College of Rheumatology Criteria (ACR20) | The ACR20 is defined as at least 20% improvement in the ACR core set values as defined below. Participants must meet 3 conditions for improvement from Baseline:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical University | Bengbu | Anhui | 233004 | China | ||
| Anhui Provincial Hospital |
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
See plan description
See plan description
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| Drug |
Administered orally |
|
| Baseline and Week 12 |
| Percentage of participants with a 50% improvement in American College of Rheumatology Criteria (ACR50) | The ACR50 is defined as at least 50% improvement in the ACR core set values as defined below. Participants must meet 3 conditions for improvement from Baseline:
| Baseline and Week 12 |
| Percentage of participants with a 70% improvement in American College of Rheumatology Criteria (ACR70) | The ACR70 is defined as at least 70% improvement in the ACR core set values as defined below. Participants must meet 3 conditions for improvement from Baseline:
| Baseline and Week 12 |
| Change from Baseline in Tender Joint Count 68 (TJC 68) | The TJC 68 is an assessment of tenderness or pain in 68 joints. Sixty-eight joints will be assessed for tenderness/pain by an independent, blinded assessor. The response to pressure/motion on each joint is assessed using the following scale: Present/Absent/Not Done/Not Applicable. A lower score indicates there is less pain or tenderness present, while a higher score indicates more pain or tenderness is present. | Baseline up to Week 12 |
| Change from baseline in Swollen Joint Count 66 (SJC 66) | The SJC 66 is an assessment of swelling in 66 joints. Sixty-six joints will be assessed for swelling by an independent, blinded assessor. The swelling present in each joint is assessed using the following scale: Present/Absent/Not Done/Not Applicable. A lower score indicates there is less swelling present, while a higher score indicates more swelling is present. | Baseline up to Week 12 |
| Change from baseline in physician's global assessment of disease activity (PhGADA_VAS) | The PhGADA_VAS is a single item that asks the physician to assess the participant's current disease activity on a 0- to 100-mm visual analog scale (VAS), with anchors of 0 = "no disease activity" and 100 = "extremely active disease." | Baseline up to Week 12 |
| Change from baseline in Simplified Disease Activity Index (SDAI) score | The simplified disease activity index (SDAI) is a composite measure that sums the total number of:
| Baseline up to Week 12 |
| Change from baseline in Clinical Disease Activity Index (CDAI) score | The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:
The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity. | Baseline up to Week 12 |
| Change from baseline of participant's global assessment of disease activity (PaGADA_VAS) | The PaGADA_VAS is a single item that asks the patient to rate the current severity of their disease activity on a 0- to 100-mm VAS, with anchors of 0 = "no disease activity" and 100 = "extremely active disease." | Baseline up to Week 12 |
| Change from baseline of Participant's global assessment of arthritis pain (VAS) | The Participants's global assessment of arthritis pain (VAS) is a single item that asks the patient to rate the current severity of their pain in relation to their RA on a 0- to 100-mm VAS, with anchors of "no pain" and "worst possible pain." | Baseline up to Week 12 |
| Change from baseline of Participant's assessment of physical function as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) | The HAQ-DI is a patient-reported questionnaire that is commonly used in RA to measure disease-associated disability (assessment of physical function). Participants answer 24 questions using a scale from 0 to 3 to score difficulty when performing daily activities over the past week (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Scores on each task are averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three represents very severe, high-dependency disability. | Baseline up to Week 12 |
| Number of participants with adverse events (AEs) | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including findings from laboratory tests | Up to approximately 4 months |
| Hefei |
| Anhui |
| 230000 |
| China |
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400010 | China |
| Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North) | Guangzhou | Guangdong | 510000 | China |
| The First Affiliated Hospital, Sun Yat Sen University | Guangzhou | Guangdong | 510080 | China |
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | 471003 | China |
| Nanyang Central Hospital | Nanyang | Henan | 473000 | China |
| Zhengzhou Central Hospital | Zhengzhou | Henan | 450007 | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
| Chenzhou No1 Peoples Hospital | Chenzhou | Hunan | 423000 | China |
| The Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | 010050 | China |
| The First Peoples Hospital of Changzhou | Changzhou | Jiangsu | 213000 | China |
| Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
| Affiliated Hospital of Nantong University | Nantong | Jiangsu | 201203 | China |
| Northern Jiangsu Peoples Hospital | Yangzhou | Jiangsu | 225001 | China |
| The First Affiliated Hospital of Nanchang University Branch Donghu | Nanchang | Jiangxi | 330006 | China |
| Pingxiang Peoples Hospital | Pingxiang | Jiangxi | 337055 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| Affiliated Hospital of Liaoning University of Traditional Chinese Medicine | Shenyang | Liaoning | 110000 | China |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital | Chengdu | Sichuan | 610071 | China |
| Affiliated Hospital of North Sichuan Medical College | Nanchong | Sichuan | 637000 | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
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