Phase III Trial of VDJ001 In Patients With Moderate-to-severe Active Rheumatoid Arthritis (NCT06726096) | Clinical Trial Compass
By InvitationPhase 3
Phase III Trial of VDJ001 In Patients With Moderate-to-severe Active Rheumatoid Arthritis
China615 participantsStarted 2025-04-09
Plain-language summary
A multicenter, randomized, double-blind, placebo-controlled, and active drug-controlled Phase III pivotal clinical trial of recombinant humanized anti-interleukin-6 receptor monoclonal antibody injection (VDJ001) for the treatment of moderate-to-severe active rheumatoid arthritis with poor response to methotrexate
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Voluntarily sign the informed consent form;
✓. Age between 18 and 75 years inclusive;
✓. Diagnosed with RA according to the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR and European League Against Rheumatism (EULAR) classification criteria;
✓. At the time of screening, judged to have moderate to severe active RA based on the following criteria: joint swelling count ≥6 (out of 66 joints) and joint tenderness count ≥6 (out of 68 joints), and must also meet C-reactive protein (CRP)/High-sensitivity C-reactive protein (hsCRP) ≥ upper limit of normal (ULN) or erythrocyte sedimentation rate (ESR) ≥28 mm/h;
✓. Have been receiving oral methotrexate (MTX) treatment for at least 12 weeks and at a stable dose (MTX dose of 7.5\~25 mg/week) for at least 4 weeks prior to randomization; subjects with a history of parenteral MTX (subcutaneous, intramuscular, or intravenous injection) are eligible for the study, but these subjects must have been receiving a stable dose of MTX 7.5\~25 mg/week oral treatment for ≥4 weeks prior to randomization;
✓. At the time of screening, if the subject is taking prednisone or an equivalent dose of corticosteroids, they must have been on a stable dose (prednisone dose ≤10mg/day) for at least 4 weeks prior to randomization.
Exclusion criteria
✕. Body weight \>100 kg or \<40 kg;
✕. ACR functional class IV or long-term bedridden/wheelchair-bound individuals;
✕. Individuals with an allergic constitution or known allergies to any components of the study treatment or other similar products;
What they're measuring
1
Proportion of subjects achieving ACR50 at week 24 (W24).
✕. Investigators determine that surgeries previously received by the subject or planned surgeries may affect the assessment of joint study evaluations;
✕. Patients with rheumatic immune diseases other than rheumatoid arthritis, uncontrolled immune system diseases requiring oral corticosteroid treatment, which the investigator deems may affect trial evaluation;
✕. Primary or secondary immunodeficiency diseases (past or currently active);
✕. History of or current tumors (except for cured and non-recurrence for at least 5 years of skin basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, breast ductal carcinoma in situ, and papillary thyroid carcinoma);
✕. History of any lymphoproliferative diseases, such as EBV-related lymphoproliferative diseases, lymphoma, leukemia, myeloproliferative diseases, multiple myeloma, or signs and symptoms suggesting current lymphatic diseases;