PSORIATIC ARTHRITIS MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: TALTZ
Product Name: TALTZ
Product Code: [IXEKIZUMAB]
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ixekizumab
CAS Number: 1143503-69-8
Current Spon
Sponsors
AZIENDA OSPEDALIERO UNIVERSITARIA DI FERRARA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Among patients routinely assessed, only patients with the following criteria will enter the study. 3.3.1 INCLUSION CRITERIA: 1. Confirmed diagnosis of PsA, according to an expert physician, and fulfilling the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria (55); 2. Age greater than or equal to 18 years; 3. Active disease (defined as 3 or more swollen joints AND 3 or more tender joints); 4. Potential indication to (new) bDMARD therapy with IXE; 5. Patients refractory to previous (at least 1) csDMARDs therapies (incomplete response, loss of efficacy or adverse events); 6. One of the involved joints has to be appropriate for US-guided synovial biopsy; 7. Patients must provide written informed consent. 8. Oral prednisone at doses of =10 mg/day (stable for at least 4 weeks) 9. No concomitant csDMARDs or concomitant background csDMARDs stable for at least 4 weeks. 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: If a patient is positive for any of the following exclusion criteria, the patient will not be eligible for the study: 1. Contraindication to start a new bDMARD treatment course; 2. Previous treatment with bDMARDs (any) or tsDMARDs (any); 3. Contraindication to US-guided synovial biopsy (e.g. uncontrolled haemostatic disorders, allergies to local anaesthetics); 4. Patients with dementia or an altered mental status, which would preclude the understanding and rendering of informed consent. 5. Known allergy or hypersensitivity to any biologic therapy. 6. Administration of live attenuated vaccine(s) (LAVs) within 6 weeks of enrolment. Or intended use of LAV during the treatment period. 7. Any history of malignancy in the last 5 years except for completely resected squamous or basal cell carcinoma of the skin. 8. For women of childbearing potential: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3- months after discontinuation. 9. Known immunodeficiency or patients immunocompromised to an extent that participation in the study would pose and unacceptable risk to the patient. 10. Clinically relevant (chronic or acute) infections, including untreated (latent) tuberculosis,hepatitis B or C or HIV infections; 11. Subjects with other autoimmune disease, e.g. Crohn's disease, Ulcerative colitis and Graves disease, except celiac disease and hypothyroidism which do not need to be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The general aim of the PRECISE study (PRECIsion medicine at the SitE of inflammation) is to explore the synovial effect of IXE in PsA patients, assessing synovial biomarkers modifications after in vitro administration of IXE to different cells/tissues obtained from refractory to csDMARDs PsA patients, and comparing them with the clinical response to systemic IXE. The primary objective of the study is to evaluate if synovial biomarkers modifications in culture supernatants and cellular homogenates (after in vitro administration of IXE in assays of different cells/tissues obtained from refractory PsA patients) predict clinical response to systemic IXE at 12 weeks.;Secondary Objective: -To evaluate if relevant biomarkers modifications, after in vitro administration of IXE, relate to ultrasonography (US) response at 12 weeks; -To evaluate if baseline histopathological data (based on Krenn’s score (44,45), and number of CD20, CD3, CD68, CD117, CD31, evaluated using immunohistochemistry - IHC) relate to clinical response to systemic IXE at 12 weeks; -To evaluate if synovial biomarkers modifications, after in vitro administration of IXE, predict clinical response to systemic IXE at 24 weeks; -To deepen the synovial effect of IXE in synovial explant cultures and FLS/PBMCs co-cultures; -To establish if a concentration-dependent effect of IXE could be responsible of relevant results obtained; -To confirm safety of US-guided synovial biopsy procedures; to confirm reliability of US-guided synovial biopsies in collecting adequate synovial tissue to guarantee FLS cultures; to establish a reliable and reproducible method of co-culture system using PBMCs and FLS.;Primary end point(s): The primary clinical endpoint of this study is response to treatment at T12, which will be primarily measured as ACR20 response (57). The primary laboratory endpoints are the sensitivity, specificity, positive predictive values (PPV), negative predictive values (NPV) and accuracy of t | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Patient-level ultrasonographic response according to multi-joint PsASon22 US score (55), measured as 20% variation in the inflammatory subscore [Time point: T12]; - Joint level ultrasonographic response according to single-joint PsASon22 US score (55) [Time point: T12]; - Other key clinical endpoints (ACR50, ACR70, DAPSA, MDA, HAQ-DI score; PGA, pain, PhGA, number of swollen/tender joints, BSA) [Time points: T12, T24]; - Response to treatment according to ACR20 response (57) [Time point: T24]; - Synovial biopsy-related adverse events [Time point: T0]; - Drug-related adverse events and treatment emergent adverse events [Time point: T12, T24].;Timepoint(s) of evaluation of this end point: 12 WEEKS, 24 WEEKS | — |
Countries
Italy
Contacts
Public ContactAcQuaRI
AOU Ferrrara
Outcome results
None listed