Actively Recruiting
Potential Role of Guselkumab in Modulating PAIN Perception and Related Gene Pathways: a Proof-of-concept Study.
Led by Fondazione Policlinico Universitario Campus Bio-Medico · Updated on 2025-05-16
26
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Psoriatic arthritis (PsA) is a chronic musculoskeletal disease that affects 0.1%-1% of the general population and about 20% of patients with psoriasis. Patients with PsA have a multifaceted pain experience, which depends on various factors, including joint inflammation, as well as peripheral and central pain sensitization. Although chronic pain is the most common symptom of PsA, few is known about the mechanisms driving it. From this point of view, the interactions between immune cells and nociceptors in the context of inflammation-related pain are emerging as a hot topic. Many studies suggested that IL-23/IL-17 pathway may play a pivotal role in this regard. This is consistent with data currently available regarding Guselkumab in PsA. Indeed, according to DISCOVER 1 and DISCOVER 2, two randomized phase III trials, patients receiving Guselkumab achieved, among others, minimal disease activity state, significant improvement in the SF-36 physical component score, and visual analog scale of pain. This study proposal aims to evaluate the potential role of Guselkumab in modulating pain perception in PsA patients from a molecular, cellular, and electrophysiological point of view.
CONDITIONS
Official Title
Potential Role of Guselkumab in Modulating PAIN Perception and Related Gene Pathways: a Proof-of-concept Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A man or a woman at least 18 and no more than 80 years of age
- Diagnosis of psoriatic arthritis (PsA) for at least 6 months and meeting CASPAR criteria at screening
- Inadequate response or intolerance to standard treatment with methotrexate and/or TNF inhibitors
- At least 3 months of stable non-biologic DMARDs (methotrexate 425 mg/week, sulfasalazine 4 g/day, hydroxychloroquine 400 mg/day, leflunomide 40 mg/day) or at least 4 weeks of NSAIDs for psoriatic arthritis
- Eligible for Guselkumab treatment according to guidelines and regulations
- Visual analog scale (VAS) pain score greater than 15 mm at enrollment
- Disease Activity index for Psoriatic Arthritis (DAPSA) score greater than 14 at enrollment
- Presence of at least one PsA subset: oligoarticular, polyarticular, distal interphalangeal joint involvement, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
- At least 1 tender peripheral joint
- At least 1 swollen peripheral joint
- C-reactive protein level 4 0.3 mg/dL
- Involvement of wrists or knees with swelling
- Nafve to biologic DMARDs or previously treated with up to 2 anti-TNF agents discontinued for lack of benefit or intolerance
- Stable dose of allowed non-biologic DMARDs if used, with no serious toxic side effects
- Stable dose of NSAIDs or analgesics if used, or no use within 2 weeks before study start
- Willing to avoid complementary therapies for PsA or psoriasis during the study
- Signed informed consent
You will not qualify if you...
- Diagnosis of fibromyalgia
- Presence of inflammatory diseases that could affect study results, including rheumatoid arthritis, axial spondyloarthritis (except primary PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
- Previous use of more than 2 anti-TNF agents
- Recent use of anti-TNF agents within specified timeframes before study start
- Previous treatment with Guselkumab
- Diagnosis of psychiatric disorders based on DSM-V
- Pregnancy or breastfeeding
- Use of systemic or joint glucocorticoids in the last 3 months
- Previous use of biologic treatments other than anti-TNF agents
- Previous use of Janus kinase inhibitors or apremilast
- Recent use of systemic immunosuppressants within 4 weeks before study start
- Use of non-biologic DMARDs other than allowed ones within 4 weeks before study start
- Current use of two or more allowed non-biologic DMARDs at baseline
- History or presence of severe or uncontrolled major organ system diseases
- Unstable cardiovascular disease or recent cardiac events
- Current or recent malignancy except certain treated skin or cervical cancers
- History of lymphoproliferative disease or signs suggestive of it
- History of chronic or recurrent infections
- Organ transplant recipients except corneal transplant over 3 months ago
- History of infected joint prosthesis not removed or replaced
- Recent serious infection or hospitalization for infection
- Recent herpes zoster infection
- Pregnancy, nursing, or plans to conceive within 12 weeks after last study dose
- Recent receipt or planned receipt of live vaccines
- Recent BCG vaccination
- Known allergies or intolerances to biologic medications or Guselkumab
- History of active granulomatous infections
- Abnormal chest X-ray indicating malignancy, serious cardiovascular or lung disease, or active infection
- History of non-tuberculous mycobacterial or opportunistic infections
- HIV infection
- Positive hepatitis B or hepatitis C status without confirmed clearance
- Recent major surgery or planned major surgery during study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Immunorheumatology Unit, Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Italy, Italy, 00128
Actively Recruiting
Research Team
L
Luca Navarini, MD
CONTACT
F
Francesca Scintu, Biologist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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