Safety and Efficacy of AIN457 in Behçet's Patients With Posterior or Panuveitis (SHIELD)

This study has been terminated.
(Core study in non-infectious uveitis in patients with Behcet's disease did not meet its primary endpoint. The study is not being terminated for safety reasons.)
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01093846
First received: March 24, 2010
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

The purpose of this extension trial is to provide patients with an opportunity to receive an additional 26 weeks of treatment yielding safety and efficacy data for AIN457 in Behçet's patients with intermediate, posterior or panuveitis and to provide a 12 week treatment-free safety follow up period.


Condition Intervention Phase
Uveitis
Biological: AIN457
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 38-week Extension to a 24 Week Multicenter, Randomized, Double-masked, Placebo Controlled Study to Assess the Difference in the Rate of Recurrent Exacerbations in Behçet's Patients With Posterior or Panuveitis Treated With AIN457 vs Placebo Adjunctive to Standard-of-care Immunosuppressive Therapy.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To determine if AIN457 is effective in reducing the rate of posterior segment uveitis exacerbations secondary to Behçet's disease, as assessed by visual acuity, anterior chamber cells and vitreous haze [ Time Frame: Wk 1-8; wk 12; wk 16; wk 22, and wk 24, week 30, week 36, week 42, week 48, week 50, and week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if AIN457 can reduce the need for standard-of-care immunosuppressive medications in patients requiring systemic immunosuppression to treat/prevent posterior segment uveitis secondary to Behçet's disease. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • To assess the safety of targeted IL-17 inhibition with AIN457 in patients with posterior segment uveitis secondary to Behçet's disease receiving treatment over the course of 1 year. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • To determine the effect of AIN457 on visual acuity and quality of life in patients with posterior segment uveitis secondary to Behçet's disease. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • To explore the relative benefit of the 2 dose regimen of AIN457 given over the course of 1 year. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • To allow an adequate treatment-free safety follow-up period (12 weeks post-treatment) [ Time Frame: week 52 and 62 ] [ Designated as safety issue: Yes ]

Enrollment: 71
Study Start Date: March 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN457C 300 mg every 2 weeks Biological: AIN457
Experimental: AIN457C 300 mg monthly Biological: AIN457
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Group 1:

  • Patients who have completed the entire treatment period of the 24 week core study

Group 2:

  • Patients who were randomized into 24-week core study and did not complete the treatment period or will not continue in the extension treatment phase

Exclusion Criteria:

Group 1:

  • Inability or unwillingness to undergo repeated subcutaneous injections
  • Inability to comply with study or follow-up procedures
  • Any medical or psychiatric condition which, in the investigator's opinion would preclude the participant from adhering to the protocol or completing the study per protocol
  • Active systemic infections during the last two weeks (exception: common cold) prior Visit16 that in the opinion of the study investigator or sponsor that would be a contraindication to additional treatment with AIN457
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation

There is no exclusion criteria for Group 2

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093846

  Show 33 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01093846     History of Changes
Other Study ID Numbers: CAIN457C2303E1, 2009-013901-33
Study First Received: March 24, 2010
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut
Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Greece: National Organization of Medicines
Italy: Comitato Etico per la Sperimentazione Clinica dei Medicinali Dell'Azienda Ospedaliero -Universitaria Careggi di Firenze
Turkey: IEGM (The General Directorate of Pharmaceuticals and Pharmacy)
Egypt: Ministry of Health and Population
Hong Kong: Department of Health
India: Drugs Controller General of India
Israel: Ministry of Health
Singapore: Department of Health 3/F, Public Health Laboratory Centre
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health, Executive Yuan, R.O.C.(TAIWAN)
Jordan: Jordan Food and Drug Administration
Tunisia: MINISTERE DE LA SANTE PUBLIQUE

Keywords provided by Novartis:
Behçet's disease
intermediate uveitis
panuveitis
posterior uveitis
uveitis

Additional relevant MeSH terms:
Panuveitis
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior

ClinicalTrials.gov processed this record on August 19, 2014