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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects achieving ACR50 at week 24 (W24).
. 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;
. 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;