Oligo and polyarticular psoriatic arthritis. MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Cosentyx
Product Name: Cosentyx
Pharmaceutical Form: Solution for injection
Sponsors
Erasmus Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A new diagnosis of PsA as per CASPAR criteria =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Evidence of ongoing infectious or malignant process obtained within 3 months prior to screening and evaluated by a qualified health care professional. 2. Current or previous treatment of arthritis with DMARDs (including methotrexate, leflunomide or sulfasalazine) or biologics (including TNF, IL12/23 or IL17 inhibitor therapies) 3. Use of any investigational drug and/or devices within 4 weeks prior to randomization or a period of five half-lives of the investigational drug, whichever is longer in duration. 4. Pregnant or nursing (lactating) women, in which pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test. 5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study drug. 6. Underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions which in the opinion of the Investigator immunocompromises the patient and/or places the patient at unacceptable risk for participation in an immunomodulatory therapy. 7. Significant medical problems or diseases, including but not limited to the following: uncontrolled hypertension (= 160/95 mmHg), congestive heart failure (New York Heart Association status of class III or IV), and uncontrolled diabetes. 8. History of clinically significant liver disease or liver injury as indicated by abnormal liver function tests (LFT) such as aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/ serum glutamic pyruvic transaminase (ALT/SGPT), alkaline phosphatase, or serum bilirubin. The Investigator should be guided by the following criteria: Any single parameter may not exceed 2 x upper limit of normal (ULN). A single parameter elevated up to and including 2 x ULN should be re-checked once more as soon as possible, and in all cases, at least prior to enrollment/randomization, to rule out laboratory error. 9. History of renal trauma, glomerulonephritis, or subjects with one kidney only, or a glomerular filtration rate (GFR) < 30 ml/min. 10. Active systemic infections during the last two weeks (exception: common cold) prior to randomization. 11. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by either a positive PPD skin test or a positive QuantiFERON TB-Gold test untreated or insufficiently treated according to the national guideline. 12. Known infection with human immunodeficiency virus, hepatitis B or hepatitis C at screening or randomization. 13. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effectiveness of the administration of secukinumab to standard care in newly diagnosed Psoriatic Arthritis (PsA) patients on the ACR50 response at 6 months. ;Secondary Objective: To compare effectiveness at 6 and 12 months between two treatment arms, mimicking standard care (arm 1) and early secukinumab arm (arm 2) using: - Patients achieving ACR 20 and 70 at 6 months - Patients achieving ACR 20, 50, 70 at 12 months - Patients achieving MDA and VLDA at 6 and 12 months - DAPSA and PASDAS scores at 6 and 12 months To compare Quality of life at 12 months between arm 1 and arm 2 using: - SF36 - PSAID - BRAF To compare work performance (presenteeism and absenteeism) at 12 months between between arm 1 and arm 2. To compare progression of radiological damage at 12 months between arm 1 and arm 2 using: - PsA modified Sharp vd Heijde (SHS) at 12 months To assess the cost-effectiveness between arm 1 and arm 2.;Primary end point(s): The ACR50 response will be used to determine efficacy. A subject is defined as an ACR50 responder if, and only if, the following three conditions are met: 1. they have a = 50% improvement in the number of tender joints (based on 68 joints) 2. they have a = 50% improvement in the number of swollen joints (based on 66 joints) 3. they have a = 50% improvement in three of the following five domains: - Patient’s global assessment of disease activity (measured on a VAS scale, 0-100) - Physician’s global assessment of disease activity (measured on a VAS scale, 0-100) - Patient’s assessment of PsA pain (measured on a VAS scale, 0-100) - Health Assessment Questionnaire – Disability Index (HAQ-DI©) score - Acute phase reactant (hsCRP or ESR) ;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: - ACR20 and ACR70 at 6 months; - ACR20/50/70 at 12 months; - MDA, VLDA, DAPSA and PASDAS at 6 and 12 months; - SF-36, BRAF and PSAID at 12 moths; - PCQ at 12 months; - The PsA-modified Sharp/van der Heijde score (SHS) at 12 months.;Secondary end point(s): - ACR20 and ACR70 at 6 months; - ACR20/50/70 at 12 months; - MDA (The proportion of subjects achieving minimal disease activity, which is defined as 5 of the following 7 domains: = 1 tender joint count, = 1 swollen joint count, PASI = 1 or BSA=3%, patient pain VAS = 15, patient global assessment of disease activity VAS = 20, HAQ-DI = 0.5, tender entheseal points = 1) at 12 months - VLDA (Very Low Disease Activity), DAPSA (Disease Activity in PSoriatic Arthritis) and PASDAS (Psoriatic Arthritis Disease Activity Score) at 6 and 12 months; - SF-36 (36-item, patient-reported survey of patient health), BRAF (Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire) and PSAID (Psoriatic Arthritis Impact of Disease Questionnaire) at 12 moths; - PCQ (Psychological Capital Questionnaire) at 12 months; - The PsA-modified Sharp/van der Heijde score (SHS) at 12 months. | — |
Countries
Netherlands
Contacts
Public ContactMarijn Vis
Erasmus Medical Center
Outcome results
None listed