Psoriatic arthritis (PsA)
Conditions
Interventions
Trade Name: Tremfya 100 mg solution for injection in pre-filled syringe.
Pharmaceutical Form: Powder and solvent for solution for injection
Trade Name: STELARA® 45 mg/0.5 mL or 90 mg/mL solution in a
Sponsors
Cliniques Universitaires Saint-Luc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed. 2. Male or non-pregnant, non-nursing female patients at least 18 years of age. 3. Patients with active PsA according to CASPAR criteria for =6 months, despite =3 months of csDMARD therapy, and =4 weeks of non-steroidal anti- inflammatory drugs (NSAIDs) therapy. 4. At least 1 swollen joint at screening or baseline (despite csDMARD therapy) with ability to perform a synovial biopsy at W0. 5. Patients with newly documented latent TB are eligible provided initiation of appropriate treatment. 6. Concomitant MTX or SSZ is permitted if started =3 months prior to study start and at a stable dose (=25 mg/week for MTX and = 3 g/day for SSZ) for =4 weeks. 7. Patients on MTX must be on stable folic acid supplementation before randomization. 8. Concomitant NSAIDs and oral corticosteroids (=10 mg prednisone/day) are permitted if stable for at least 2 weeks. 9. Allowed concomitant medications are to remain stable through week 24. 10. Patients cannot have previously received any biologic agent. 11. DMARDs other than MTX or sulfasalazine (SSZ) must be interrupted. DMARDs other than MTX are not allowed within 4 weeks prior to or during trial participation. A washout period needs to be considered. (8 weeks for leflunomide). 12. At least one joint (small or large) to biopsy in order to get synovial tissue. Small joints must have an US grey-scale score > 2 on Doppler Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1. Contraindications for needle-arthroscopy such as joint replacement (in the affected knee or ankle joint) or anticoagulation. 2. Use of any investigational drug and/or devices within 4 weeks of baseline, or a period of 5 half-lives of the investigational drug, whichever is longer. 3. Conditions/situations such as: a. Patients with conditions/concomitant diseases making them non evaluable for the primary endpoint b. Impossibility to meet specific protocol requirements (e.g. blood sampling) c. Patient is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol d. Uncooperative or any condition that could make the patient potentially noncompliant to the study procedures 4. Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before baseline. 5. Any intramuscular corticosteroid injection within 2 weeks before baseline. 6. Prior treatment with a biologic agent. 7. A history of active tuberculosis (TB).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the transcriptomic effects of Ustekinumab, Guselkumab, and Adalimumab in synovial biopsies (total and single cells) from PsA patients with active disease despite a csDMARDs, obtained prior to and 24 weeks after initiation of therapy. ;Secondary Objective: Evaluate clinical response at W24, by using DAS-44 or ACR20/50/70 response criteria. Identify candidate synovial markers/pathways associated with response to ustekinumab, guselkumab, and anti-TNFalpha therapy in PsA by correlating molecular signals at baseline with the clinical response observed at week 24. Perform analyses of the association between molecular changes induced by anti-IL23, anti-IL23/12 and anti-TNF in the synovium, and core or non-core (clinical, biological, imaging) variables informative about response to therapy. ;Primary end point(s): The primary endpoint of the study is not the comparative efficacy of the 3 drugs, but the comparative molecular changes they induce in the synovium.;Timepoint(s) of evaluation of this end point: 24 weeks after onset of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy outcome measures used in this study are standard measures used in PsA disease activity assessment: EULAR (DAS) and ACR score. Assess corelation between the molecular response, clinical and Imaging responses (ultrasound and MRI);Timepoint(s) of evaluation of this end point: 24 weeks after onset of treatment Optionally : According site clinical practice at week 6, 12, 18 after onset of treatment | — |
Countries
Belgium
Contacts
Public ContactClinical trial Center
Cliniques Universitaires Saint-Luc
Outcome results
None listed