Joint inflammation rash
Conditions
Interventions
Investigational treatment:
* Secukinumab 150mg/1mL, liquid formulation provided in 1 mL PFS (Pre-filled
syringe)
* Secukinumab 75mg/0.5mL, liquid formulation provided in 0.5 mL PFS
Reference treatmen
Sponsors
Novartis
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: - Confirmed diagnosis of Enthesitis-related arthritis (ERA) or Juvenile psoriatic arthritis (JPsA) according to the international League of Associations for Rheumatology (ILAR) classification criteria of at least 6 months duration. - Active disease (ERA or JPsA) defined as having both: at least 3 active joints at least 1 site of active enthesitis at baseline or documented by history. - Inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drugs (NSAID) - Inadequate response (at least 2 months) or intolerance to at least 1 Disease-modifying antirheumatic drugs (DMARD) - No concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs.
Exclusion criteria
Exclusion criteria: - Patients fulfilling any ILAR diagnostic JIA category other than ERA or JPsA. - Patients who have ever received biologic immunomodulating agents. - Patients taking any non-biologic DMARD except for MTX (or sulfasalazine for ERA patients only). - Patients with active uncontrolled inflammatory bowel disease or active uncontrolled uveitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate that the time to flare in Treatment Period 2 is longer with secukinumab for combined ERA and JPsA groups than with placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effect of secukinumab treatment for all patients and each JIA category in Treatment Period 1 up to Week 12 (end of Treatment period 1) with respect to: * JIA ACR (American College of Rheumatology) 30/50/70/90/100and inactive disease status * Each JIA ACR core component * Change from baseline Juvenile Arthritis Disease Activity Score (JADAS) * Total enthesitis count * Total dactylitis count 2. To evaluate withdrawal effect of secukinumab treatment for all patients and each JIA category during and at the end of Treatment Period 2 with respect to: * JIA ACR 30/50/70/90/100 and inactive disease status 3. To evaluate Pharmacokinetics (PK) of secukinumab and confirm the predicted dose in Treatment Period 1 4. To evaluate the safety/tolerability and immunogenicity of Secukinumab | — |
Countries
Netherlands
Outcome results
None listed