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New treatment option for Rheumatoid Arthritis (RA)
Official title An Artificial Intelligence-powered Approach to Precision Immunotherapy of Human Arthritis
ClinicalTrials.gov ID: NCT07013110
What this study is testing
What is dnaJP1?
dnaJP1 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for rheumatoid arthritis (ra).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- 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
- Agree to use acceptable methods of contraception for e.g. oral contraceptive pills, implanted contraception, barrier methods, and intra-uterine...
You likely can't join if
- On prednisolone \>10 mg daily
- History of receiving:
- conventional synthetic (cs-) disease modifying anti-rheumatic drugs (DMARDs) such as sulfasalazine, methotrexate, and leflunomide administered 6...
- tissue-specific (tsp.-) DMARDs such as JAK inhibitors
- History of lymphoma
- Active malignancy requiring treatment the last 5 years except for non-melanoma skin cancers and carcinoma of the cervix in situ
See the full eligibility criteria
- 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
- Agree to use acceptable methods of contraception for e.g. oral contraceptive pills, implanted contraception, barrier methods, and intra-uterine devices
- Allowed used of oral Prednisone up to 10 mg/day and NSAIDs, as prescribed by the treating physician
- Able and willing to comply with the protocol, including availability for all scheduled study visits and assessments. Using the 2010 ACR/EULAR classification criteria for RA, classification as definite RA is based upon...
- Number and site of involved joints:
- 2 to 10 large joints (from among shoulders, elbows, hips, knees, and ankles) = 1 point
- 1 to 3 small joints (from among the metacarpophalangeal joints, proximal interphalangeal joints, second through fifth metatarsophalangeal joints, thumb interphalangeal joints, and wrists) = 2 points
- 4 to 10 small joints = 3 points
- Greater than 10 joints (including at least 1 small joint) = 5 points
- Serological abnormality (rheumatoid factor or anti-citrullinated peptide/protein antibody)
- Low positive (above the upper limit of normal [ULN]) = 2 points
- High positive (greater than three times the ULN) = 3 points
- Elevated acute phase response (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]) above the ULN = 1 point
- Symptom duration at least six weeks = 1 point
- On prednisolone \>10 mg daily
- History of receiving:
- conventional synthetic (cs-) disease modifying anti-rheumatic drugs (DMARDs) such as sulfasalazine, methotrexate, and leflunomide administered 6 months prior to screening . biological (b-) DMARDs such as rituximab...
- tissue-specific (tsp.-) DMARDs such as JAK inhibitors
- History of lymphoma
- Active malignancy requiring treatment the last 5 years except for non-melanoma skin cancers and carcinoma of the cervix in situ
- Pregnancy
- Breast-feeding
- Active Infection, e.g., Hepatitis B, tuberculosis
- A known hypersensitivity to dnaJP1 or to any of the excipients
- Significant cardiac history, e.g., have experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart...
- A history or presence of dermatological, cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, haematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that...
- An eGFR based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of \<40 ml/min/1.73 m2
- A history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 times the ULN or the most recent available total bilirubin 1.5 times the ULN
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.