gewrichtsaandoeningen, reumatische aandoeningen active psoriatic arthritis
Conditions
Interventions
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Provide written, signed and dated informed consent before any study assessment is performed. 2. Male or female patients at least 18 years of age. 3. Diagnosis of PsA as per CASPAR criteria with active PsA for at least 6 months and a TJC >= 3 of 78 and SJC >= 3 of 76 at Baseline. 4. Patients must have a total synovitis PDUS score >= 2 and inflammation related to PD signal >= 2 for at least 2 (affected joints as observed via PDUS) of 48 joints at the Screening visit and at the Baseline visit (before injection). 5. At least 1 clinically-involved enthesitis site at Screening and at the Baseline visit (before injection) defined by SPARCC index different from 0. 6. Rheumatoid factor and anti-cyclic citrullinated peptide (anti-CCP) negative at Screening. 7.Patients with PsA who are taking NSAIDs should be on a stable dose for at least 2 weeks prior to enrollment and remain on a stable dose throughout the 24-week study period. 8.Patients with PsA who are taking steroids must have received steroids at least 3 months prior to the Baseline visit and be on a stable dose of
Exclusion criteria
Exclusion criteria: 1. Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process obtained within 3 months prior to Screening and evaluated by a qualified physician. 2. Previous exposure to secukinumab or other biologic drug directly targeting interleukin 17 (IL-17) or IL-17 receptor. 3. Patients taking high-potency opioid analgesics (e.g. methadone, hydromorphone, morphine). 4. Use of any investigational drug and/or devices within 4 weeks before randomization or a period of 5 half-lives of the investigational drug, whichever is longer. 5. Any change in the dose of oral corticosteroids in the last 4 weeks prior to the Baseline visit or use of i.v. intramuscular or intra-articular corticosteroid during the last 4 weeks prior to the enrollment visit. 6. Patients who have previously been treated with TNFa inhibitors (investigational or approved). 7. History of hypersensitivity to the study drug or its excipients or to drugs of similar classes. 8. Previous treatment with any cell-depleting therapies including but not limited to anti CD20 investigational agents (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti CD19). 9. Prohibited psoriasis treatments/medications with topical corticosteroids in the last 4 weeks prior to randomization 10. Pregnant or nursing (lactating) women 11. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g. 20 weeks in EU) 12. Active ongoing inflammatory diseases other than PsA that might confound the evaluation of the benefit of secukinumab therapy. 13. Underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions which in the opinion of the Investigator immunocompromise the patient and/or place the patient at unacceptable risk for participation in an immunomodulatory therapy. 14. 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 (as per investigator's judgement). 15. History of clinically significant liver disease or liver injury as indicated by abnormal liver function tests (LFT) such as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or serum bilirubin. 16. History of renal trauma, glomerulonephritis, or patients with 1 kidney only, or a serum creatinine level exceeding 1.5 mg/dL (132.6 µmol/L). 17. Screening total white blood cell (WBC) count = 5 mm or according to local practice/guidelines) or a positive QuantiFERON TB-Gold test. Patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate that there is a difference between secukinumab and placebo in terms of joint synovitis response over 12 weeks as measured by the PDUS global OMERACT-EULAR synovitis score (GLOESS) of the affected joints (out of 48 joints) in PsA patients with an inadequate response (IR) to non biologic DMARDs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary objectives • To demonstrate that the efficacy of secukinumab at Week 12 is superior to placebo based on the proportion of patients achieving an American College of Rheumatology (ACR) 20 response. • To demonstrate that the efficacy of secukinumab at Week 12 is superior to placebo based on the proportion of patients achieving an ACR 50 response. • To demonstrate that the clinical response of secukinumab at Week 12 is superior to placebo based on the change in Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index from Baseline to Week 12. Other secondary objectives • To evaluate the therapeutic effect of secukinumab versus placebo on joint synovitis from Baseline to Week 8 using the GLOESS score out of 48 joints. • To evaluate the therapeutic effect of secukinumab versus placebo on enthesitis at Week 12 using the OMERACT enthesitis score for each affected enthesis. • To evaluate the overall safety, tolerability and immunogenicity of secukinumab. Exploratory obejecttives • To evaluate the therapeutic effect on joint synovitis for patients in the placebo group once switched to secukinumab from Week 12 to Week 24 and Week 24 to Week 52, as assessed by the improvement in synovitis from Week 12 to 24 and Week 24 to Week 52 using the GLOESS score and its components out of 48 joints. • To evaluate the therapeutic effect on joint synovitis in the initial secukinumab group as assessed by the improvement in synovitis from Baseline to Week 24 and to Week 52 using the GLOESS score and its components out of 48 joints. • To evaluate the therapeutic effect on enthesitis for patients in the placebo group who switched to secukinumab from Week 12 to Week 24 and Week 24 to Week 52 using the OMERACT individual enthesitis score and its morphologic components. • To evaluate the therapeutic effect on enthesitis for patients in the initial secukinumab group from Baseline to Week 24 and from Week 24 to Week 52 using the OMERACT | — |
Countries
The Netherlands
Outcome results
None listed