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A Study Investigating the Efficacy and Safety of BGB-45035 Versus Placebo in Adults With Moderate to Severe Active Rheumatoid Arthritis

NCT07100938

TerminatedPhase 2

Sponsor: BeiGene

Conditions: Rheumatoid Arthritis

Interventions: BGB-45035, Placebo

Countries: China

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Diagnosed with rheumatoid arthritis (RA) based on American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for at least 3 months prior to screening
* Demonstrated an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) (Hydroxychloroquine, methotrexate \[MTX\], leflunomide, or sulfasalazine) or 1 biologic disease-modifying antirheumatic drug (bDMARD)/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) treatment
* Must be on stable dose of one of the following permitted therapies for ≥ 4 weeks prior to screening and during the study: methotrexate between 7.5 mg to 25 mg/week, hydroxychloroquine up to 400 mg/day, leflunomide up to 20 mg/day, or sulfasalazine between 1000 mg/day to 3000 mg/day

Exclusion Criteria:

* Class IV RA based on American College of Rheumatology revised criteria for classification of functional status in rheumatoid arthritis
* Patients with a history of cancer in the last 5 years before the Screening Visit, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin
* Have failed more than 2 b/tsDMARDs (eg, excluded if have failed 2 bDMARDs and 1 tsDMARD)

Locations (29)

Bengbu, Anhui, China
Hefei, Anhui, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Chongqing, Chongqing Municipality, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Nanning, Guangxi, China
Harbin, Heilongjiang, China
Luoyang, Henan, China
Nanyang, Henan, China
Zhengzhou, Henan, China
Changsha, Hunan, China
Chenzhou, Hunan, China
Hohhot, Inner Mongolia, China
Changzhou, Jiangsu, China
Nanjing, Jiangsu, China
Nantong, Jiangsu, China
Yangzhou, Jiangsu, China
Nanchang, Jiangxi, China
Pingxiang, Jiangxi, China
Changchun, Jilin, China
Shenyang, Liaoning, China
Xi'an, Shaanxi, China
Shanghai, Shanghai Municipality, China
Chengdu, Sichuan, China
Nanchong, Sichuan, China
Hangzhou, Zhejiang, China