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38 Week Extension Study to CAIN457C2303 (SHIELD)

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ClinicalTrials.gov Identifier: NCT01093846
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
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Uveitis
Interventions Drug: AIN457
Drug: Placebo AIN457
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AIN457 300 mg Every 2 Weeks AIN457 300 mg Monthly AIN457 Placebo
Hide Arm/Group Description 300 mg every two weeks 300 mg monthly [Not Specified]
Period Title: Overall Study
Started 19 18 22
Completed 0 0 1
Not Completed 19 18 21
Reason Not Completed
Adverse Event             0             0             1
Lack of Efficacy             0             0             4
Condition no longer required study drug             1             1             1
Administrative Problems             18             17             15
Arm/Group Title AIN457 300 mg Every 2 Weeks AIN457 300 mg Monthly AIN457 Placebo Total
Hide Arm/Group Description 300 mg every two weeks 300 mg monthly [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 19 18 22 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 18 participants 22 participants 59 participants
36.5  (10.01) 36.8  (13.07) 34.9  (11.20) 36.0  (11.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 18 participants 22 participants 59 participants
Female
6
  31.6%
5
  27.8%
11
  50.0%
22
  37.3%
Male
13
  68.4%
13
  72.2%
11
  50.0%
37
  62.7%
1.Primary Outcome
Title 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.
Hide Description 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 .
Time Frame 62 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Termination
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AIN457 300mg Every 2 Weeks AIN457 300mg Monthly Placebo
Hide Arm/Group Description AIN457 300mg every 2 weeks. Safety is provided over the entire treatment period. This includes the core and extension period. AIN457 300mg monthly Safety is provided over the entire treatment period. This includes the core and extension period. Placebo Safety is provided over the entire treatment period. This includes the core and extension period.
All-Cause Mortality
AIN457 300mg Every 2 Weeks AIN457 300mg Monthly Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AIN457 300mg Every 2 Weeks AIN457 300mg Monthly Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/39 (17.95%)   8/39 (20.51%)   5/39 (12.82%) 
Cardiac disorders       
Supraventricular tachycardia  1  1/39 (2.56%)  0/39 (0.00%)  0/39 (0.00%) 
Ear and labyrinth disorders       
Vertigo  1  0/39 (0.00%)  1/39 (2.56%)  0/39 (0.00%) 
Eye disorders       
Cataract cortical (Fellow eye)  1  0/39 (0.00%)  0/39 (0.00%)  1/39 (2.56%) 
Cataract nuclear (Fellow eye)  1  0/39 (0.00%)  0/39 (0.00%)  1/39 (2.56%) 
Cataract subcapsular (Fellow eye)  1  0/39 (0.00%)  0/39 (0.00%)  1/39 (2.56%) 
Choroiditis (Fellow eye)  1  1/39 (2.56%)  0/39 (0.00%)  0/39 (0.00%) 
Glaucoma (Fellow eye)  1  0/39 (0.00%)  0/39 (0.00%)  1/39 (2.56%) 
Retinal infiltrates (Fellow eye)  1  1/39 (2.56%)  0/39 (0.00%)  0/39 (0.00%) 
Retinal infiltrates (Study eye)  1  1/39 (2.56%)  0/39 (0.00%)  0/39 (0.00%) 
Uveitis (Fellow eye)  1  1/39 (2.56%)  1/39 (2.56%)  0/39 (0.00%) 
Uveitis (Study eye)  1  0/39 (0.00%)  1/39 (2.56%)  1/39 (2.56%) 
Gastrointestinal disorders       
Abdominal pain  1  0/39 (0.00%)  1/39 (2.56%)  0/39 (0.00%) 
Aphthous stomatitis  1  0/39 (0.00%)  1/39 (2.56%)  0/39 (0.00%) 
Diarrhoea  1  0/39 (0.00%)  1/39 (2.56%)  0/39 (0.00%) 
Diarrhoea haemorrhagic  1  0/39 (0.00%)  0/39 (0.00%)  1/39 (2.56%) 
Enteritis  1  0/39 (0.00%)  1/39 (2.56%)  0/39 (0.00%) 
Haematemesis  1  0/39 (0.00%)  1/39 (2.56%)  0/39 (0.00%) 
Lower gastrointestinal haemorrhage  1  0/39 (0.00%)  1/39 (2.56%)  0/39 (0.00%) 
General disorders       
Fatigue  1  1/39 (2.56%)  0/39 (0.00%)  0/39 (0.00%) 
Immune system disorders       
Behcet's syndrome  1  0/39 (0.00%)  1/39 (2.56%)  0/39 (0.00%) 
Behcet's syndrome (Fellow eye)  1  0/39 (0.00%)  1/39 (2.56%)  0/39 (0.00%) 
Behcet's syndrome (Study eye)  1  0/39 (0.00%)  1/39 (2.56%)  0/39 (0.00%) 
Infections and infestations       
Folliculitis  1  2/39 (5.13%)  0/39 (0.00%)  0/39 (0.00%) 
Hypopyon (Fellow eye)  1  1/39 (2.56%)  0/39 (0.00%)  0/39 (0.00%) 
Urinary tract infection  1  1/39 (2.56%)  0/39 (0.00%)  0/39 (0.00%) 
Injury, poisoning and procedural complications       
Fall  1  1/39 (2.56%)  0/39 (0.00%)  0/39 (0.00%) 
Foot fracture  1  1/39 (2.56%)  0/39 (0.00%)  0/39 (0.00%) 
Investigations       
Intraocular pressure increased (Fellow eye)  1  0/39 (0.00%)  0/39 (0.00%)  1/39 (2.56%) 
Weight decreased  1  1/39 (2.56%)  0/39 (0.00%)  0/39 (0.00%) 
Metabolism and nutrition disorders       
Diabetes mellitus  1  0/39 (0.00%)  1/39 (2.56%)  0/39 (0.00%) 
Musculoskeletal and connective tissue disorders       
Bone pain  1  0/39 (0.00%)  1/39 (2.56%)  0/39 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis  1  1/39 (2.56%)  0/39 (0.00%)  0/39 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  0/39 (0.00%)  1/39 (2.56%)  0/39 (0.00%) 
Skin and subcutaneous tissue disorders       
Skin lesion  1  0/39 (0.00%)  1/39 (2.56%)  0/39 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AIN457 300mg Every 2 Weeks AIN457 300mg Monthly Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28/39 (71.79%)   27/39 (69.23%)   25/39 (64.10%) 
Eye disorders       
Cataract subcapsular (Fellow eye)  1  4/39 (10.26%)  1/39 (2.56%)  0/39 (0.00%) 
Cataract subcapsular (Study eye)  1  4/39 (10.26%)  1/39 (2.56%)  1/39 (2.56%) 
Eye pain (Study eye)  1  1/39 (2.56%)  2/39 (5.13%)  2/39 (5.13%) 
Retinal vasculitis (Study eye)  1  2/39 (5.13%)  0/39 (0.00%)  1/39 (2.56%) 
Vision blurred (Fellow eye)  1  0/39 (0.00%)  6/39 (15.38%)  1/39 (2.56%) 
Vision blurred (Study eye)  1  0/39 (0.00%)  2/39 (5.13%)  3/39 (7.69%) 
Visual acuity reduced (Study eye)  1  4/39 (10.26%)  2/39 (5.13%)  1/39 (2.56%) 
Vitreous floaters (Study eye)  1  1/39 (2.56%)  0/39 (0.00%)  2/39 (5.13%) 
Gastrointestinal disorders       
Abdominal pain  1  1/39 (2.56%)  0/39 (0.00%)  2/39 (5.13%) 
Abdominal pain upper  1  3/39 (7.69%)  3/39 (7.69%)  1/39 (2.56%) 
Aphthous stomatitis  1  3/39 (7.69%)  2/39 (5.13%)  2/39 (5.13%) 
Diarrhoea  1  2/39 (5.13%)  3/39 (7.69%)  2/39 (5.13%) 
Mouth ulceration  1  0/39 (0.00%)  0/39 (0.00%)  2/39 (5.13%) 
Nausea  1  4/39 (10.26%)  3/39 (7.69%)  2/39 (5.13%) 
Toothache  1  2/39 (5.13%)  1/39 (2.56%)  0/39 (0.00%) 
Vomiting  1  2/39 (5.13%)  0/39 (0.00%)  3/39 (7.69%) 
General disorders       
Fatigue  1  2/39 (5.13%)  2/39 (5.13%)  4/39 (10.26%) 
Non-cardiac chest pain  1  2/39 (5.13%)  0/39 (0.00%)  1/39 (2.56%) 
Oedema peripheral  1  3/39 (7.69%)  2/39 (5.13%)  0/39 (0.00%) 
Pyrexia  1  6/39 (15.38%)  3/39 (7.69%)  4/39 (10.26%) 
Infections and infestations       
Conjunctivitis infective (Study eye)  1  1/39 (2.56%)  2/39 (5.13%)  1/39 (2.56%) 
Influenza  1  2/39 (5.13%)  4/39 (10.26%)  1/39 (2.56%) 
Nasopharyngitis  1  2/39 (5.13%)  2/39 (5.13%)  1/39 (2.56%) 
Oral herpes  1  0/39 (0.00%)  0/39 (0.00%)  2/39 (5.13%) 
Rash pustular  1  2/39 (5.13%)  0/39 (0.00%)  1/39 (2.56%) 
Sinusitis  1  0/39 (0.00%)  2/39 (5.13%)  1/39 (2.56%) 
Upper respiratory tract infection  1  3/39 (7.69%)  5/39 (12.82%)  1/39 (2.56%) 
Urinary tract infection  1  1/39 (2.56%)  1/39 (2.56%)  2/39 (5.13%) 
Investigations       
Alanine aminotransferase increased  1  0/39 (0.00%)  0/39 (0.00%)  2/39 (5.13%) 
Blood glucose increased  1  0/39 (0.00%)  2/39 (5.13%)  0/39 (0.00%) 
Intraocular pressure increased (Study eye)  1  2/39 (5.13%)  3/39 (7.69%)  0/39 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  4/39 (10.26%)  3/39 (7.69%)  3/39 (7.69%) 
Pain in extremity  1  3/39 (7.69%)  1/39 (2.56%)  2/39 (5.13%) 
Nervous system disorders       
Dizziness  1  0/39 (0.00%)  3/39 (7.69%)  0/39 (0.00%) 
Headache  1  9/39 (23.08%)  7/39 (17.95%)  10/39 (25.64%) 
Psychiatric disorders       
Anxiety  1  0/39 (0.00%)  3/39 (7.69%)  0/39 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  2/39 (5.13%)  0/39 (0.00%)  0/39 (0.00%) 
Oropharyngeal pain  1  0/39 (0.00%)  2/39 (5.13%)  2/39 (5.13%) 
Rhinorrhoea  1  0/39 (0.00%)  1/39 (2.56%)  2/39 (5.13%) 
Skin and subcutaneous tissue disorders       
Acne  1  1/39 (2.56%)  0/39 (0.00%)  2/39 (5.13%) 
Erythema  1  1/39 (2.56%)  1/39 (2.56%)  2/39 (5.13%) 
Hirsutism  1  2/39 (5.13%)  0/39 (0.00%)  1/39 (2.56%) 
Skin lesion  1  1/39 (2.56%)  0/39 (0.00%)  2/39 (5.13%) 
Vascular disorders       
Hypertension  1  1/39 (2.56%)  2/39 (5.13%)  1/39 (2.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses were reduced to summary of AEs occurred during the extension and safety follow-up periods.
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01093846     History of Changes
Other Study ID Numbers: CAIN457C2303E1
2009-013901-33
First Submitted: March 24, 2010
First Posted: March 26, 2010
Results First Submitted: February 12, 2015
Results First Posted: February 22, 2016
Last Update Posted: February 22, 2016