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Secukinumab Safety and Efficacy in JPsA and ERA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031782
Recruitment Status : Active, not recruiting
First Posted : January 26, 2017
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE November 2, 2016
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date June 11, 2019
Actual Study Start Date  ICMJE May 23, 2017
Estimated Primary Completion Date October 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
Time to flare in Treatment Period 2 [ Time Frame: From Week 12 until max Week 104 ]
Patients will be randomised 1:1 secukinumab:Placebo at beginning of event-driven Treatment Period 2 at Week 12.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03031782 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
  • Change from baseline for Juvenile idiopathic arthritis (JIA) American college of rheumatology (ACR) 30/50/70/90/100 response [ Time Frame: 12 weeks ]
  • Change from baseline for JIA ACR core components [ Time Frame: 12 weeks ]
  • Change from baseline Juvenile Arthritis Disease Activity Score (JADAS) score [ Time Frame: 12 weeks ]
  • Change from baseline in total enthesitis count [ Time Frame: 12 weeks ]
  • Change from baseline in total dactylitis count [ Time Frame: 12 weeks ]
  • Percentage of participants with JIA ACR 30/50/70/90/100 and inactive disease [ Time Frame: From week 12 to up to week 104 ]
    To evaluate the effect of withdrawal of secukinumab treatment
  • Secukinumab serum concentration [ Time Frame: 104 weeks ]
    Will assess secukinumab serum concentrations over time
  • Number of participants with reported Adverse Events [ Time Frame: 104 weeks ]
  • Percentage of participants with anti-secukinumab anitbodies [ Time Frame: 104 weeks ]
    Will be assessed by immunogenicity techniques from blood samples drawn during the study.
  • Change from baseline for inactive disease status [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Secukinumab Safety and Efficacy in JPsA and ERA
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Juvenile Psoriatic Arthritis
  • Enthesitis-related Arthritis
Intervention  ICMJE
  • Drug: AIN457
    Secukinumab (AIN457) is a high-affinity fully human monoclonal anti-human antibody that targets IL-17A and neutralizes activity.
  • Other: Matched placebo
    Matched placebo to AIN457 for use in the double blind Treatment Period 2
Study Arms  ICMJE
  • Experimental: Treatment Period 2 - active
    secukinumab (AIN457 - pre-filled syringe) for patients with a minimum American college of Rheumatology (ACR) 30 response in Treatment Period 1
    Intervention: Drug: AIN457
  • Placebo Comparator: Treatment Period 2 - placebo
    Placebo comparator (matched to secukinumab treatment) for patients with a minimum American college of Rheumatology (ACR) 30 response in Treatment Period 1
    Intervention: Other: Matched placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 10, 2019)
86
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2017)
80
Estimated Study Completion Date  ICMJE December 29, 2020
Estimated Primary Completion Date October 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Germany,   Italy,   Poland,   Russian Federation,   South Africa,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03031782
Other Study ID Numbers  ICMJE CAIN457F2304
2016-003761-26 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP