GenSci120 in RA patients who did not respond to DMARDs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind study comparing several doses of GenSci120 with adalimumab and placebo in adults with moderately to severely active RA and inadequate DMARD response. Participants are assigned in a 1:1:1:1:1 ratio to low, medium, and high GenSci120 doses, adalimumab, or placebo, with 90 participants per group (total 450). The trial includes a screening period, a 14-week placebo-controlled treatment phase, a 14-week extension phase, and a 10-week follow-up, across 17 visits. Key outcomes focus on efficacy and safety, with inclusion requiring active disease and prior bDMARD/tsDMARD exposure in at least 40% of participants. The study is led by Changchun GeneScience Pharmaceutical Co., Ltd., with Peking University People’s Hospital as a site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants who voluntarily sign an informed consent form before the start of activities related to this study, understand the procedures and methods of this study, and are willing to strictly follow the clinical study protocol to complete this study;
2. Male or female participants aged 18- 70 years (inclusive) when signing the informed consent form;
3. Participants diagnosed with RA according to the 2010 RA classification criteria of the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR), with ACR functional classification Class I-III at screening;
4. Moderately to severely active RA is defined as TJC ≥ 6 and SJC ≥ 6 at screening and baseline based on 68/66 joint counts, and ESR or C-reactive protein (CRP)/hsCRP exceeding the upper limit of normal at screening. Joints with major surgery history will not be included in TJC and SJC;

Exclusion Criteria:

1. Known allergy to any component in the GenSci120 formulation, or a history of allergic reactions to any drugs, compounds, foods, or other substances, or a history of hypersensitivity.
2. Any autoinflammatory disease or autoimmune disease (excluding secondary Sjogren's syndrome) other than RA, including but not limited to psoriatic arthritis, inflammatory bowel disease, ankylosing spondylitis, systemic lupus erythematosus, systemic sclerosis or idiopathic inflammatory myopathy, multiple sclerosis or other central demyelinating diseases, primary Sjogren's syndrome, immunodeficiency syndrome, etc;
3. Other joint disorders which could interfere with the assessment of joint disease activity according to the investigators' judgement, such as severe osteoarthritis;
4. History of lymphoproliferative disorders, such as lymphoma, or presence of signs or symptoms of lymphoproliferative disorders, including abnormal lymph node enlargement or hepatosplenomegaly;
5. Those with malignant disease or with a history of malignant disease;

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Wei WANG
• Email: wangwei13@genscigroup.com
• Phone: +86 18201085833

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.