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Phase III Study in Refractory Behcet's Disease (SHIELD)

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ClinicalTrials.gov Identifier: NCT00995709
Recruitment Status : Completed
First Posted : October 15, 2009
Results First Posted : August 31, 2015
Last Update Posted : August 31, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Behcet Disease
Interventions: Drug: AIN457
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AIN457C 300 mg Every 2 Week Dosage Regimen AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
AIN457C 300 mg Monthly Dosage Regimen

AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.

One patient in the AIN457 300 mg monthly group (PID 0161/00002) was randomized; however, this patient did not meet eligibility criteria and never received study medication

Placebo to AIN457C Placebo was administered in 2 s.c. injections

Participant Flow:   Overall Study
    AIN457C 300 mg Every 2 Week Dosage Regimen   AIN457C 300 mg Monthly Dosage Regimen   Placebo to AIN457C
STARTED   39   40   39 
COMPLETED   32   31 [1]   34 
NOT COMPLETED   7   9   5 
Adverse Event                4                2                0 
Lack of Efficacy                0                1                4 
Withdrawal by Subject                0                4                1 
Lost to Follow-up                1                0                0 
Death                0                1                0 
Protocol Violation                2                1                0 
[1] patient in the 300 mg monthly group was randomized,was not eligible,never received study medication



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
a. One patient who screen-failed was inadvertently randomized to the AIN457 300 mg monthly group. This patient did not receive any study medication.

Reporting Groups
  Description
AIN457C 300 mg Every 2 Week Dosage Regimen AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
AIN457C 300 mg Monthly Dosage Regimen (a) AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
Placebo to AIN457C Placebo was administered in 2 s.c. injections
Total Total of all reporting groups

Baseline Measures
   AIN457C 300 mg Every 2 Week Dosage Regimen   AIN457C 300 mg Monthly Dosage Regimen (a)   Placebo to AIN457C   Total 
Overall Participants Analyzed 
[Units: Participants]
 39   40   39   118 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.2  (10.96)   34.0  (11.86)   32.5  (10.34)   34.2  (11.09) 
Gender 
[Units: Participants]
       
Female   12   11   15   38 
Male   27   29   24   80 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   0   0   1   1 
Not Hispanic or Latino   39   39   37   115 
Unknown or Not Reported   0   1   1   2 
Region of Enrollment 
[Units: Participants]
       
France   1   0   0   1 
Turkey   19   18   18   55 
Germany   1   1   1   3 
Greece   3   5   4   12 
Italy   3   2   2   7 
Spain   1   0   1   2 
United States   0   2   0   2 
Egypt   1   2   2   5 
Israel   2   0   1   3 
Jordan   0   2   1   3 
Tunisia   2   1   2   5 
Hong Kong   1   1   1   3 
India   1   2   1   4 
Korea, Republic Of   2   4   4   10 
Singapore   1   0   1   2 
Taiwan, Province Of China   1   0   0   1 


  Outcome Measures

1.  Primary:   Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment   [ Time Frame: Baseline to week 24 ]

2.  Primary:   Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment   [ Time Frame: 24 weeks ]

3.  Secondary:   Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set)   [ Time Frame: 24 weeks ]

4.  Secondary:   To Determine the Effect of AIN457 on Macular Edema and Visual Acuity in Patients With Posterior Segment Uveitis Secondary to Behçet’s Disease as Determined by Optical Coherence Tomography.   [ Time Frame: baseline, and wk 24 (end of study) ]

5.  Secondary:   To Establish the Impact of AIN457 on Quality of Life of Posterior Segment Uveitis Patients Secondary to Behçet’s Disease Refractory to Systemic Immunomodulatory Therapy as Measured by National Eye Institute Visual Function Questionaire-25 and Euroqol.   [ Time Frame: screening, and wk 24 (end of study) ]

6.  Secondary:   To Observe the Effect of AIN457 on the Systemic Non-ocular Manifestations of Behçet’s Disease in Patients With Posterior Segment Uveitis Requiring Systemic Immunosuppression as Measured by the Bechet’s Disease Current Activity Form.   [ Time Frame: baseline and wk 24 (end of study) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00995709     History of Changes
Other Study ID Numbers: CAIN457C2303
2009-011237-27 ( EudraCT Number )
First Submitted: October 13, 2009
First Posted: October 15, 2009
Results First Submitted: February 12, 2015
Results First Posted: August 31, 2015
Last Update Posted: August 31, 2015