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New treatment option for Psoriatic Arthritis (PsA)
Official title Preventing Structural Damage in Early Psoriatic Arthritis
ClinicalTrials.gov ID: NCT07486843
What this study is testing
What is Amgevita 40Mg Solution for Injection?
Amgevita 40Mg Solution for Injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for psoriatic arthritis (psa).
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
- Investigators hypothesize that TNFi is superior to SC MTX in preventing structural damage in early, treatment-naïve PsA, assessed using HR-pQCT. The study aims to ascertain: \- The effect of SC MTX and TNFi (adalimumab biosimilar) on erosion and enthesiophyte progression in early PsA by HR-pQCT.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥18 years old
- without severe deformity in MCPJ
- with active disease, which is defined as ≥1 tender joints and ≥1 swollen joints, despite previous treatment with nonsteroidal anti-inflammatory drugs...
- with at least one poor prognostic factor (eg, polyarthritis, structural damage on HR-pQCT or CR, elevated acute phase reactants, dactylitis, nail...
- symptom duration ≤ 2 years
You likely can't join if
- on csDMARDs unless being prescribed for skin psoriasis (e.g. cyclosporin)
- limited in ability to perform usual self-care, vocational, and avocational activities
- pregnancy
- previous therapy with b/tsDMARDs
- predominant active axial PsA or significant uveitis/inflammatory bowel disease requiring immediate b/tsDMARDs therapy
- the presence of active inflammatory diseases other than PsA
See the full eligibility criteria
- ≥18 years old
- without severe deformity in MCPJ
- with active disease, which is defined as ≥1 tender joints and ≥1 swollen joints, despite previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for ≥ 4 weeks
- with at least one poor prognostic factor (eg, polyarthritis, structural damage on HR-pQCT or CR, elevated acute phase reactants, dactylitis, nail involvement or HAQ-DI\>1)
- symptom duration ≤ 2 years
- on csDMARDs unless being prescribed for skin psoriasis (e.g. cyclosporin)
- limited in ability to perform usual self-care, vocational, and avocational activities
- pregnancy
- previous therapy with b/tsDMARDs
- predominant active axial PsA or significant uveitis/inflammatory bowel disease requiring immediate b/tsDMARDs therapy
- the presence of active inflammatory diseases other than PsA
- active infection in 2 weeks before randomization or a history of ongoing, chronic, or recurrent infections including tuberculosis
- history of malignant disease within the past 5 years (excluding basal cell carcinoma or actinic keratosis, in-situ cervical cancer, or non-invasive malignant colon polyps)
- contraindications to MTX or adalimumab
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. 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.