An Artificial Intelligence-powered Approach to Precision Immunotherapy of Human Arthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorProf Salvatore Albani
About this trial
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.
Eligibility criteria
Qualifiers
Diagnosis of rheumatoid arthritis (RA) based on 2010 ACR/EULAR classification criteria
DAS28-ESR score more than 3.2 (at least moderately active)
Male or female with age 21 or above
Ability to understand and sign informed consent
Disqualifiers
On prednisolone >10 mg daily
conventional synthetic (cs-) disease modifying anti-rheumatic drugs (DMARDs) such as sulfasalazine, methotrexate, and leflunomide administered 6 months prior to screening
tissue-specific (tsp.-) DMARDs such as JAK inhibitors
History of lymphoma
Trial design
Treatments tested in this trial
- dnaJP1
- Placebo
Treatment groups
124 Participants
are divided into 2 treatment groupsSponsors and collaborators
Prof Salvatore Albani
Lead sponsor
Singapore Health Services
Sponsor institution
Singapore General Hospital
Collaborator
Source ClinicalTrials.gov