A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis

Phase 3

Withdrawn

Conditions: Joint inflammation
rash
10003816

Registration Number: NL-OMON45692

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 4

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

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To demonstrate that the time to flare in Treatment Period 2 is longer with<br /><br>secukinumab for combined ERA and JPsA groups than with placebo</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To evaluate the effect of secukinumab treatment for all patients and each<br /><br>JIA category in Treatment Period 1 up to Week 12 (end of Treatment period 1)<br /><br>with respect to:<br /><br>* JIA ACR (American College of Rheumatology) 30/50/70/90/100and inactive<br /><br>disease status<br /><br>* Each JIA ACR core component<br /><br>* Change from baseline Juvenile Arthritis Disease Activity Score (JADAS)<br /><br>* Total enthesitis count<br /><br>* Total dactylitis count<br /><br>2. To evaluate withdrawal effect of secukinumab treatment for all patients and<br /><br>each JIA category during and at the end of Treatment Period 2<br /><br>with respect to:<br /><br>* JIA ACR 30/50/70/90/100 and inactive disease status<br /><br>3. To evaluate Pharmacokinetics (PK) of secukinumab and confirm the predicted<br /><br>dose in Treatment Period 1<br /><br>4. To evaluate the safety/tolerability and immunogenicity of Secukinumab</p><br>