active psoriatic arthritis MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: MTX Hexal
Pharmaceutical Form: Tablet
CAS Number: 59-05-2
Other descriptive name: METHOTREXATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Phar
Sponsors
Fraunhofer Gesellschaft for its Institute Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with active psoriatic arthritis who are naïve to UST will be stratified to either without MTX-therapy or on MTX-treatment for at least 12 weeks prior to screening. Active PsA is defined as • TJC =4 and SJC =4 (66/68 joint count) and • DAS28 = 3,2 • PsA according to CASPAR criteria • Presence of chest x-ray without signs of active or latent infection (esp. for tuberculosis) within the last 3 months prior to screening • Permitted pre-treatment of PsA with up to three biologic-agents, whereupon only one biologic agent must be withdrawn due to inadequate response. • For MTX naïve patients: Previous use of NSAID • at least age of 18 years • Written informed consent obtained prior to the initiation of any protocol-required procedures • Compliance to study procedures and study protocol Inclusion criteria related to MTX • For the group on MTX: Patients must have MTX treatment (dosage =15mg/week) for at least 12 weeks prior to screening and stable MTX dosages of 15mg once weekly for at least 4 weeks prior to screening • Compliance of intake of MTX must be documented • For the group without MTX therapy: patients must be eligible for MTX treatment (according to SmPC) and have not failed prior MTX treatment for the treatment of PsA 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 98 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 98
Exclusion criteria
Exclusion criteria: • previous use of UST or any other anti-IL23 agent Exclusion criteria related to IMP • according to SmPC • For the group without MTX: Inadequate Response to prior MTX-treatment for Psoriatic Arthritis Exclusion criteria related to general health: • previous B-cell depleting therapy • Patients with other chronic inflammatory articular disease or systemic autoimmune disease with musculoskeletal symptoms • Patients with active Tb • Patients with latent Tb, measured by Interferon gamma release assay, that are not pre-treated for at least 1 months and planned to be treated 9 months in total with INH once a day according to local guidelines • Any active infection, a history of recurrent clinically significant infection, a history of recurrent bacterial infections with encapsulated organisms • Primary or secondary immunodeficiency • History of cancer with curative treatment not longer than 5 years ago except basal-cell carcinoma of the skin that had been excised • Evidence of significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome • History of a severe psychological illness or condition • Known hypersensitivity to any component of the product • Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test • Males or females of reproductive potential not willing to use effective contraception (e.g. contraceptive pill, IUD, physical barrier) • Alcohol, drug or chemical abuse Exclusion criteria related to prior treatments: • Previous DMARD therapy other than MTX at least for the last 28 days prior to screening due to washout time of different DMARD therapies (including Leflunomide etc.) • Previous immunosuppressive biologic therapy at least for the last 60 days prior to screening due to washout time of different immunosuppressive biologic therapies (including antiTNF etc.) • current participation in another interventional clinical trial Exclusion criteria related to laboratory: • Haemoglobin 1.4 mg / dl for women or 1.6 mg / dl for men • AST or ALT > 2.5 time upper limit of norm Exclusion criteria related to formal aspects: • Underage or incapable patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate non-inferiority of mean values of DAS28 at week 24 of UST monotherapy compared to add-on to MTX with stratification according to patients on or without MTX before randomization.;Secondary Objective: • To demonstrate non-inferiority of mean DAS28 at week 52 Comparative analysis at all visits as illustrated in Flow Chart of •DAS28 and change in DAS28 incl. DAS28-ESR remission or low disease of UST +/- MTX treatment •functional outcome (TJC/SJC assessment) •ACR 20/50/70 response incl. changes in ACR core set (SJC, TJC, HAQ, patient’s and physician’s global assessment, pain, CRP and ESR) •PASI, BSA and BASDAI •treatment adherence measured by withdrawal of therapy and drug accountability •compliance using compliance questionnaire for rheumatology (CQR5) •quality of life measured by HAQ, EQ5D, DLQI •functional outcome (Enthesitis (LEI), Dactylitis assessment) •mtNAPSI •US assessment (PsASon22) selected sites) •safety events (frequency and seriousness) ;Primary end point(s): Assessment of mean DAS28 at week 24 ;Timepoint(s) of evaluation of this end point: week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assessment of mean DAS28 at week 52 Assessment of - TJC/SJC (66/68) - ACR response - Enthesitis (LEI) - Dactylitis (number and severity of digits involved) - HAQ Other efficacy parameters: - VAS pain - BASDAI (due to radiological confirmed axial involvement) - PASI - mtNAPSI - DLQI - EQ5D - CRQ5;Timepoint(s) of evaluation of this end point: week 52 week 4, 16, 24, 28, 40 and 52 | — |
Countries
Germany
Contacts
Public ContactClinical Research
Fraunhofer ITMP
Outcome results
None listed