Proximod, a Selective Sphingosine-1-phosphate Receptor 1 Modulator in Patients With Moderate-to-s… (NCT07335952) | Clinical Trial Compass
CompletedPhase 2
Proximod, a Selective Sphingosine-1-phosphate Receptor 1 Modulator in Patients With Moderate-to-severe Active Rheumatoid Arthritis: a Double-blind, Randomised, Placebo-controlled, Phase 2 Trial.
China179 participantsStarted 2024-09-02
Plain-language summary
The goal of this multicenter, randomized, double-blind, placebo-controlled phase 2 clinical trial is to evaluate the efficacy and safety of proximod in active rheumatoid arthritis patients with inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). The main questions it aims to answer are:
Evaluate the efficacy of different doses of proximod in active RA patients who have inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), and provide a basis for dose selection in the confirmatory phase III clinical study.
Explore the changes of S1P and SPHK before and after treatment of proximod. Participants will take proximod 5mg/10mg daily or placebo for three months and will be followed up for 1 month.
Who can participate
Age range
18 Years – 70 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
. Patients aged 18-70 years
. Diagnosed rheumatoid arthritis (RA) according to the 2010 American College of Rheumatology- European League against Rheumatism classification criteria at least 3 months before screening.
. Have active RA as defined by ≥ 6 swollen joints (based on 66 joint counts) and ≥6 tender joints (based on 68 joint counts) at screening and baseline.
. High-sensitivity CRP concentrations equal to or exceeding the upper limit of normal value (ULN) or erythrocyte sedimentation rate (ESR) \> ULN
. Have an inadequate response to ≥ 1 csDMARDs, defined by moderate to high disease activity (DAS28 \>3.2, CDAI\>2.8, SDAI\>3.3).
Exclusion criteria
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
The proportion of patients achieving American College of Rheumatology (ACR) 20 response at week 12.
. An intra-articular or other injectable corticosteroid within 4 weeks prior to Screening
. Patients receiving daily corticosteroid treatment at a dosage \> 10 mg/day or with an unstable dose within four weeks before inclusion.If glucocorticoids have been discontinued, they should be stopped for at least 2 weeks before the first administration of the study drug.
. Those who are using non-steroidal anti-inflammatory drugs (except paracetamol) and whose dosage has not been stable within 4 weeks before the first administration of the study drug, or those who cannot continue to take the drug at the original stable dosage during the trial. If they have stopped taking the drug, they need to stop taking the drug for at least 2 days or 5 half-lives (whichever is longer) before the first administration of the study drug.
. Patients who have received treatment with Iguratimod, interferon (such as Roferon, Intron A, Rebetron, etc.), drugs known to have strong immunosuppressive or immunomodulatory effects (including total Glucosides of Paeony, Tripterygium wilfordii Hook.f, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, 6 - mercaptopurine, etc.), or technetium \[99Tc\] methylene diphosphonate injection within 4 weeks before the first administration of the study drug.
. Use of opioids within 4 weeks before the first administration of the study drug.
. Oral traditional Chinese medicines for the treatment of RA and other inflammatory diseases within 4 weeks before the first administration of the study drug.
. Subjects who have received integrin Alpha V antibodies or cell depletion therapy within 3 months before the first administration of the study drug or within 5 half - lives (whichever is longer).
. Received JAK inhibitors and/or S1P agonists within 5 half - lives or within 2 weeks (whichever is longer).