Secukinumab Safety and Efficacy in JPsA and ERA
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 2 - 17 |
| Updated: | 3/13/2019 |
| Start Date: | May 23, 2017 |
| End Date: | December 30, 2020 |
| Contact: | Novartis Pharmaceuticals |
| Email: | Novartis.email@novartis.com |
| Phone: | 1-888-669-6682 |
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
This is a double-blind, placebo-controlled, event-driven randomized withdrawal study to
investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic
Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related
Arthritis (ERA). The study is divided into 3 parts (plus a post-treatment follow-up period)
consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a
randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment
Period 2.
investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic
Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related
Arthritis (ERA). The study is divided into 3 parts (plus a post-treatment follow-up period)
consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a
randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment
Period 2.
Inclusion Criteria:
1. 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.
2. 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.
3. Inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal
anti-inflammatory drugs(NSAID)
4. Inadequate response (at least 2 months) or intolerance to at least 1 Disease-modifying
antirheumatic drugs (DMARD)
5. No concomitant use of second line agents such as disease-modifying and/or
immunosuppressive drugs.
Exclusion Criteria:
1. Patients fulfilling any ILAR diagnostic JIA category other than ERA or JPsA.
2. Patients who have ever received biologic immunomodulating agents
3. Patients taking any non-biologic DMARD except for MTX (or sulfasalazine for ERA
patients only).
4. Patients with active uncontrolled inflammatory bowel disease or active uncontrolled
uveitis.
Other protocol-defined inclusion/exclusion criteria apply.
We found this trial at
7
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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