Psoriatic Arthritis (PsA)Phase 4NCT07486843
Preventing Structural Damage in Early Psoriatic Arthritis
A Phase 4 study testing Amgevita 40Mg Solution for Injection and Methotrexate (Metoject® prefilled pen) in people with Psoriatic Arthritis (PsA), run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis (PsA)
- What is being tested?
- Amgevita 40Mg Solution for Injection and Methotrexate (Metoject® prefilled pen)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteHong Kong
- Study dates
- 16 Mar 2026to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong
Prof. Tam, 852-35051429, lstam@cuhk.edu.hk
About this study
Official title: Methotrexate Versus TNF Inhibition in Preventing Structural Damage in Early Psoriatic Arthritis: A Randomized Trial Using HR-pQCT (MeTEPsA Trial)
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.
Participants will be:
- Randomized in a 1:1 ratio to either the SC MTX group or the TNFi group.
- HR-pQCT of MCPJ 2-4 will be performed at baseline, week 24, and one year.
The primary outcome is the comparison of change in erosion volume over MCPJ 2-4 across 48 weeks between the SC MTX group (group 1) and the TNFi group (group 2), assessed by HR-pQCT.
- Conditions
- Psoriatic Arthritis (PsA)
- Being tested
- Amgevita 40Mg Solution for Injection, Methotrexate (Metoject® prefilled pen)
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amgevita 40Mg Solution for InjectionDrug
Amgevita 40mg
Methotrexate (Metoject® prefilled pen)Drug
Metoject® PEN 7.5 mg, Metoject® PEN 10 mg, Metoject® PEN 15 mg, Metoject® PEN 20 mg, Metoject® PEN 25 mg
| Study group | Role | What they receive |
|---|---|---|
| MTX | Active comparator | Not described Receives: Drug: Methotrexate (Metoject® prefilled pen) |
| Adalimumab biosimilar | Active comparator | Not described Receives: Drug: Amgevita 40Mg Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in erosion volume (mm³) in the MCPJ 2-4 over a period of 48 weeks between Group 1 (MTX) and Group 2 (TNFi group) assessed by HR-pQCT
Measured: 48 weeks
Secondary outcomes (4)
The change in erosion volume (mm³) in the MCPJ 2-4 over a period of 24 weeks
Measured: 24 weeks
The proportion (in percentage) of erosions showing partial healing at weeks 24 and 48
Measured: Week 24 and 48
The change in the enthesiophyte volume (mm³) at weeks 24 and 48
Measured: Weeks 24 and 48
The proportion (in percentage) of enthesiophytes exhibiting progression at weeks 24 and 48
Measured: Week 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start16 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic Arthritis (PsA)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai-Shan Tam, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486843
- Sponsor's protocol ID
- 2024.661
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methotrexate Versus TNF Inhibition in Preventing Structural Damage in Early Psoriatic Arthritis: A Randomized Trial Using HR-pQCT (MeTEPsA Trial)
- ClinicalTrials.gov ID
- NCT07486843
- Acronym / sponsor ID
- 2024.661
- Conditions
- Psoriatic Arthritis (PsA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Participants will be:
- Randomized in a 1:1 ratio to either the SC MTX group or the TNFi group.
- HR-pQCT of MCPJ 2-4 will be performed at baseline, week 24, and one year.
The primary outcome is the comparison of change in erosion volume over MCPJ 2-4 across 48 weeks between the SC MTX group (group 1) and the TNFi group (group 2), assessed by HR-pQCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTX | Active comparator | Drug: Methotrexate (Metoject® prefilled pen) |
| Adalimumab biosimilar | Active comparator | Drug: Amgevita 40Mg Solution for Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amgevita 40Mg Solution for InjectionAmgevita 40mg | Drug | Adalimumab biosimilar |
| Methotrexate (Metoject® prefilled pen)Metoject® PEN 7.5 mg, Metoject® PEN 10 mg, Metoject® PEN 15 mg, Metoject® PEN 20 mg, Metoject® PEN 25 mg | Drug | MTX |
Primary outcome
The change in erosion volume (mm³) in the MCPJ 2-4 over a period of 48 weeks between Group 1 (MTX) and Group 2 (TNFi group) assessed by HR-pQCT
Time frame: 48 weeks
4 secondary outcomes
The change in erosion volume (mm³) in the MCPJ 2-4 over a period of 24 weeks
Time frame: 24 weeks
The proportion (in percentage) of erosions showing partial healing at weeks 24 and 48
Time frame: Week 24 and 48
The change in the enthesiophyte volume (mm³) at weeks 24 and 48
Time frame: Weeks 24 and 48
The proportion (in percentage) of enthesiophytes exhibiting progression at weeks 24 and 48
Time frame: Week 24 and 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amgevita 40Mg Solution for Injection and Methotrexate (Metoject® prefilled pen) in people with Psoriatic Arthritis (PsA), run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in erosion volume (mm³) in the MCPJ 2-4 over a period of 48 weeks between Group 1 (MTX) and Group 2 (TNFi group) assessed by HR-pQCT (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.