Taking people in ItalyPhase 3
Testing how far arthritis medicine can be reduced in psoriatic arthritis
Tests slowly lowering immunosuppressive medicine in adults with psoriatic arthritis and stable symptoms.
Key facts
- Who runs it
- Universitaetsklinikum Erlangen AöR
- Where
- Rome, ItalySee the siteAlso in 1 other country, 3 sites
- Registry title
- An unblinded clinical Trial with random assignment to Treatment Groups in adult patients with psoriatic arthrits to evaluate how far immunosuppressive medication can be tapered without recurrence of symptoms
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 370 people, planned
- Started
- 18 Sept 2020
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional
- Record updated
- 28 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with psoriatic arthritis whose disease has been under good control for at least 6 months on stable medication. It tests slowly reducing that medication.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Psoriatic arthritis (CASPAR criteria) in minimal disease activity for at least 6 months, and also at screening and baseline in the joint and tendon-attachment measures
- Earlier treatment
- Must have been on the same drug and dose for at least 6 months: csDMARDs (leflunomide, sulfasalazine, methotrexate) and/or bDMARDs or tsDMARDs (for example adalimumab, secukinumab, apremilast), and/or glucocorticoids up to 5 mg prednisolone equivalent
Main reasons for not taking part
- Another rheumatological or immune disease, such as rheumatoid arthritis or lupus
- Active immune-mediated disease that is untreated or needs immunosuppressive treatment
- Current treatment with other DMARDs or drugs under development
- Systemic glucocorticoids above 5 mg prednisolone equivalent daily in the last 6 months
- Pregnant or nursing women
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Written informed consent obtained from the subject
- Adult male or female subject; age ≥18
- Diagnosis of PsA according to CASPAR criteria
- Disease status “MDA” for at least 6 months; MDA is defined as the presence of 5 of the following 7 criteria: a) tender joint count ≤1 b) swollen joint count ≤1 c) tender entheseal point count ≤1 (means: remission) d) PASI ≤1 OR body surface area (BSA) ≤3% e) patient pain VAS ≤15 f) patient global activity VAS ≤20 g) HAQ-DI ≤0.5
- Disease status “MDA+” at screening and baseline; MDA+ is defined as the presence of 5 of the 7 criteria for MDA, whereby all musculoskeletal domains a)-c) must fulfil the criteria
- Subject should have been treated without alterations of therapy (fixed dose and drug) for at least 6 months with one or more of the following drugs: a) csDMARD Leflunomide (e.g. Arava), Sulfasalazine (e.g. Azulfidine RA, Pleon RA), Methotrexate (e.g. Lantarel, Metex) AND/OR b) bDMARD/tsDMARD Etanercept (e.g. Enbrel, Erelzi, Benepali), Adalimumab (e.g. Humira, Amgevita, Imraldi, Hyrimoz), Infliximab (e.g. Remicade, Zessly, Inflectra), Golimumab (Simponi), Certolizumab (Cimzia), Abatacept (Orencia), Apremilast (Otezla), Ustekinumab (Stelara), Secukinumab (Cosentyx), Ixekizumab (Taltz), Guselkumab (Tremfya) Upadacitinib (Rinvoq) Risankizumab (Skyrizi) Tofacitinib (Xeljanz) AND/OR c. Glucocorticoids (≤ 5mg prednisolone equivalent)
Who cannot take part
- Concomitant florid immune mediated disease such as autoimmune hepatitis that is untreated and/or requires immunosuppressive treatment
- Use of any inadmissible medication (e.g. current treatment with DMARDs other than mentioned above or drugs under development)
- Treatment with systemic glucocorticoids (daily dose >5mg prednisolone equivalent) during the last 6 months before randomization. Intra-articular or entheseal injections of glucocorticoids do not constitute an exclusion criterion
- Any anti-inflammatory (excluding NSAIDs) or immunosuppressive therapy for other reasons than PsA or psoriasis during the last 3 months before screening
- Diagnosis of any other rheumatological/ immunological disease such as rheumatoid arthritis, SLE, PSS, MCTD, M. Behcet or M. Wegener
- Nursing mother or pregnant woman
Where in Italy
Also in 1 other country, 3 sites
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
About the trial
What the trial wants to find out
To evaluate the impact of tapering systemic immunosuppressive therapy in a treat-to-target approach on maintaining minimal disease activity (MDA) in adult subjects with psoriatic arthritis (PsA) and stable MDA.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- A prospective, randomized, controlled, open label, assessor-blinded, parallel-group Phase III clinical trial to evaluate the impact of tapering systemic immunosuppressive therapy in a treat-to-target approach on maintaining minimal disease activity in adult subjects with psoriatic arthritis
- Plain-language title
- Testing how far arthritis medicine can be reduced in psoriatic arthritisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 28 September 2026