Actively Recruiting
An Artificial Intelligence-powered Approach to Precision Immunotherapy of Human Arthritis
Led by Prof Salvatore Albani · Updated on 2025-08-11
124
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
Sponsors
P
Prof Salvatore Albani
Lead Sponsor
S
Singapore General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical study is a multi-center, randomized, double-blind, placebo-controlled, outpatient study comparing the efficacy of combination of dnaJP1 peptide and hydroxychloroquine versus combination of placebo and hydroxychloroquine in patients with moderately to severely active RA who are naive to cs-, b-, tsp.-DMARDs. A sample size of 124 patients will be enrolled in the study. Each patient will receive either combination of dnaJP1 peptide and hydroxychloroquine or combination of placebo and hydroxychloroquine in 1:1 allocation ratio.
CONDITIONS
Official Title
An Artificial Intelligence-powered Approach to Precision Immunotherapy of Human Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of rheumatoid arthritis (RA) based on 2010 ACR/EULAR classification criteria
- DAS28-ESR score more than 3.2 indicating at least moderately active RA
- Male or female aged 21 years or older
- Ability to understand and sign informed consent
- Agree to use acceptable contraception methods such as oral contraceptive pills, implanted contraception, barrier methods, or intra-uterine devices
- Allowed to use oral Prednisone up to 10 mg/day and NSAIDs as prescribed by physician
- Able and willing to follow the study protocol and attend all scheduled visits and assessments
You will not qualify if you...
- Taking prednisolone over 10 mg daily
- History of using conventional synthetic (cs-) DMARDs, biological (b-) DMARDs, or tissue-specific (tsp.-) DMARDs such as JAK inhibitors within 6 months prior to screening
- History of lymphoma
- Active malignancy requiring treatment in the last 5 years except certain skin cancers and cervical carcinoma in situ
- Pregnancy
- Breastfeeding
- Active infection such as Hepatitis B or tuberculosis
- Known allergy to dnaJP1 or its ingredients
- Significant recent cardiac events such as myocardial infarction, unstable ischemic heart disease, stroke, or severe heart failure within 12 weeks of study entry
- Serious or unstable illnesses that may increase risk with hydroxychloroquine or investigational product or interfere with data interpretation
- Estimated glomerular filtration rate (eGFR) less than 40 ml/min/1.73 m2
- Chronic liver disease with elevated liver enzymes or bilirubin beyond specified limits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Singapore General Hospital
Singapore, Singapore, 169856
Actively Recruiting
Research Team
S
Salvatore Albani, MD PhD
CONTACT
G
Grace Compton-Tan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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