38 Week Extension Study to CAIN457C2303 (SHIELD)
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| ClinicalTrials.gov Identifier: NCT01093846 |
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Recruitment Status :
Terminated
(Core Study in Behcet's disease with mostly active uveitis did not meet its primary endpoint)
First Posted : March 26, 2010
Results First Posted : February 22, 2016
Last Update Posted : February 22, 2016
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Uveitis | Drug: AIN457 Drug: Placebo AIN457 | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 59 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| 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 (SHIELD Study) |
| Study Start Date : | March 2010 |
| Actual Primary Completion Date : | January 2011 |
| Actual Study Completion Date : | January 2011 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: AIN457 300 mg every 2 weeks |
Drug: AIN457
300mg every 2 weeks |
| Experimental: AIN457 300 mg monthly |
Drug: AIN457
300mg every 4 weeks |
| Placebo Comparator: Placebo |
Drug: Placebo AIN457
Placebo to AIN457 |
Primary Outcome Measures :
- The Effect of Continuous Treatment With Subcutaneous AIN457 Compared to Placebo in Reducing the Rate of Recurrent Ocular Exacerbations in Behçet's Patients With Intermediate Uveitis, Posterior Uveitis or Panuveitis in Group 1. [ Time Frame: 62 weeks ]The primary objective of the study was to determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet's patients with intermediate uveitis, posterior uveitis or panuveitis in patients who completed the core study and continued treatment in the extension study (Group 1).Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses are available in the summary of AEs which occurred during the extension and safety follow-up periods and are shown in the safety section .
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093846
Locations
| United States, Maryland | |
| Novartis Investigative Site | |
| Baltimore, Maryland, United States, 21205-2005 | |
| Egypt | |
| Novartis Investigative Site | |
| Alexandria, Egypt | |
| France | |
| Novartis Investigative Site | |
| Grenoble, France, 38043 | |
| Germany | |
| Novartis Investigative Site | |
| Heidelberg, Germany, 69120 | |
| Greece | |
| Novartis Investigative Site | |
| Athens, GR, Greece, 115 27 | |
| Novartis Investigative Site | |
| Ioannina, GR, Greece, 455 00 | |
| Novartis Investigative Site | |
| Larissa, GR, Greece, 41110 | |
| Novartis Investigative Site | |
| Patras, Greece, 26500 | |
| Hong Kong | |
| Novartis Investigative Site | |
| Hongkong, Hong Kong | |
| Israel | |
| Novartis Investigative Site | |
| Ramat Gan, Israel, 52621 | |
| Novartis Investigative Site | |
| Tel-Aviv, Israel, 64239 | |
| Jordan | |
| Novartis Investigative Site | |
| Amman, Jordan, 11195 | |
| Korea, Republic of | |
| Novartis Investigative Site | |
| Seoul, Korea, Korea, Republic of, 110 744 | |
| Novartis Investigative Site | |
| Seoul, Korea, Korea, Republic of, 120-752 | |
| Singapore | |
| Novartis Investigative Site | |
| Singapore, Singapore, 308433 | |
| Spain | |
| Novartis Investigative Site | |
| Barcelona, Catalunya, Spain, 08028 | |
| Novartis Investigative Site | |
| Barcelona, Catalunya, Spain, 08035 | |
| Taiwan | |
| Novartis Investigative Site | |
| Lin-Ko, Taiwan, 33305 | |
| Tunisia | |
| Novartis Investigative Site | |
| Sfax, Tunisia | |
| Turkey | |
| Novartis Investigative Site | |
| Altindag / Ankara, Turkey, 06590 | |
| Novartis Investigative Site | |
| Ankara, Turkey, 06100 | |
| Novartis Investigative Site | |
| Ankara, Turkey, 06490 | |
| Novartis Investigative Site | |
| Fatih / Istanbul, Turkey, 34098 | |
| Novartis Investigative Site | |
| Istanbul, Turkey, 34093 | |
| Novartis Investigative Site | |
| Izmir, Turkey, 35380 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01093846 |
| Other Study ID Numbers: |
CAIN457C2303E1 2009-013901-33 |
| First Posted: | March 26, 2010 Key Record Dates |
| Results First Posted: | February 22, 2016 |
| Last Update Posted: | February 22, 2016 |
| Last Verified: | January 2016 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
|
uveitis |
Additional relevant MeSH terms:
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Uveitis Uveal Diseases Eye Diseases |
Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |