Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety,Tolerability and Efficacy of Intravitreal LFG316 in Patients With Active Non-infectious Intermediate-, posterior-or Panuveitis ,

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: NCT01526889
Recruitment Status : Completed
First Posted : February 6, 2012
Results First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Non-infectious Intermediate Uveitis
Non-infectious Posterior Uveitis
Non-infectious Panuveitis
Interventions Drug: LFG316
Drug: Conventional Therapy
Enrollment 25
Recruitment Details  
Pre-assignment Details Approximately 24 patients were planned to be enrolled. A total of 25 patients were randomized (18 patients in LFG316 group and 7 patients in conventional therapy group).
Arm/Group Title LFG316 Conventional Therapy
Hide Arm/Group Description LFG316 administered intravitreally Conventional treatment was selected by the investigator
Period Title: Treatment Period
Started 18 7
Completed 16 7
Not Completed 2 0
Reason Not Completed
Adverse Event             2             0
Period Title: Treatment Extension Period
Started 5 0
Completed 4 0
Not Completed 1 0
Reason Not Completed
Administrative problems             1             0
Arm/Group Title LFG316 Conventional Therapy Total
Hide Arm/Group Description LFG316 administered intravitreally Conventional treatment was selected by the investigator Total of all reporting groups
Overall Number of Baseline Participants 18 7 25
Hide Baseline Analysis Population Description
Safety analysis set (SAS): All patients who received study drug (LFG316 or conventional treatment) were included in the safety analysis set.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 7 participants 25 participants
45.3  (14.84) 39.1  (14.89) 43.6  (14.81)
[1]
Measure Analysis Population Description: SAS
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 7 participants 25 participants
Female
7
  38.9%
4
  57.1%
11
  44.0%
Male
11
  61.1%
3
  42.9%
14
  56.0%
[1]
Measure Analysis Population Description: SAS
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 7 participants 25 participants
Hispanic or Latino
2
  11.1%
0
   0.0%
2
   8.0%
Not Hispanic or Latino
16
  88.9%
7
 100.0%
23
  92.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Safetyanalysis set
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 7 participants 25 participants
Caucasian
17
  94.4%
6
  85.7%
23
  92.0%
Black
1
   5.6%
1
  14.3%
2
   8.0%
[1]
Measure Analysis Population Description: SAS
1.Primary Outcome
Title Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye
Hide Description

Response rate as defined by:

  1. An improvement of 2 or more steps in vitreous haze (scale of 0 to 4), relative to baseline OR
  2. An improvement of 10 or more letters in visual acuity (VA), relative to baseline OR
  3. An improvement of 2 or more steps in anterior chamber cells (ACC) score (scale of 0 to 4), relative to baseline OR
  4. Absence of chorioretinal lesions as determined by the investigator
Time Frame Day 85 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy 1 analysis set: All patients in the safety analysis set who received any study treatment (LFG316 or conventional treatment) with evaluable efficacy data for at least one efficacy endpoint(s) (ocular assessments) and with no major protocol deviations that had an impact on efficacy data.
Arm/Group Title LFG316 Conventional Therapy
Hide Arm/Group Description:
LFG316 administered intravitreally
Conventional treatment was selected by the investigator
Overall Number of Participants Analyzed 18 7
Measure Type: Number
Unit of Measure: Participants
Improvement of vitreous haze ≥2 steps (N=15,6) Number Analyzed 15 participants 6 participants
3 3
Improvement of VA ≥ 10 letters (N=15,6) Number Analyzed 15 participants 6 participants
0 1
Improvement of ACC score ≥2 steps (N=7, 1) Number Analyzed 7 participants 1 participants
0 0
Resolution of chorioretinal lesions (N= 3, 0) Number Analyzed 3 participants 0 participants
0
2.Primary Outcome
Title Number of Participants With Remission in Study Eye - Treatment Period
Hide Description

Remission (complete response) was defined as any patient who had:

  • a vitreous haze score of 0 or 0.5 (scale of 0 to 4) in the study eye, AND
  • an anterior chamber cell score of 0 (scale of 0 to 4), AND
  • no chorioretinal lesions in the study eye, AND
  • was off all immune modulatory therapy (systemic, corticosteroids and topical), AND
  • without any worsening of uveitis during the trial.
Time Frame Day 85 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy 1 analysis set
Arm/Group Title LFG316 Conventional Therapy
Hide Arm/Group Description:
LFG316 administered intravitreally
Conventional treatment was selected by the investigator
Overall Number of Participants Analyzed 18 7
Measure Type: Count of Participants
Unit of Measure: Participants
2
  11.1%
0
   0.0%
3.Secondary Outcome
Title Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Hide Description

Vitreous haze score (based on funduscopic exam): 0, 0.5/Trace, 1+, 2+, 3+, 4+

Vitreous haze score (scale of 0 to 4) with a score of 4 being the most hazed.

Time Frame Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy 1 analysis set
Arm/Group Title LFG316 Conventional Therapy
Hide Arm/Group Description:
LFG316 administered intravitreally
Conventional treatment was selected by the investigator
Overall Number of Participants Analyzed 18 7
Measure Type: Count of Participants
Unit of Measure: Participants
Day 2 Number Analyzed 15 participants 7 participants
0
0
   0.0%
0
   0.0%
0.5/Trace
2
  13.3%
1
  14.3%
1+
10
  66.7%
4
  57.1%
2+
1
   6.7%
1
  14.3%
3+
2
  13.3%
1
  14.3%
4+
0
   0.0%
0
   0.0%
Day 8 Number Analyzed 6 participants 1 participants
0
0
   0.0%
0
   0.0%
0.5/Trace
1
  16.7%
0
   0.0%
1+
4
  66.7%
1
 100.0%
2+
0
   0.0%
0
   0.0%
3+
1
  16.7%
0
   0.0%
4+
0
   0.0%
0
   0.0%
Day 15 Number Analyzed 16 participants 7 participants
0
2
  12.5%
1
  14.3%
0.5/Trace
3
  18.8%
1
  14.3%
1+
6
  37.5%
4
  57.1%
2+
3
  18.8%
1
  14.3%
3+
0
   0.0%
0
   0.0%
4+
2
  12.5%
0
   0.0%
Day 29 Number Analyzed 15 participants 7 participants
0
0
   0.0%
3
  42.9%
0.5/Trace
4
  26.7%
1
  14.3%
1+
10
  66.7%
3
  42.9%
2+
0
   0.0%
0
   0.0%
3+
0
   0.0%
0
   0.0%
4+
1
   6.7%
0
   0.0%
Day 43 Number Analyzed 14 participants 6 participants
0
6
  42.9%
2
  33.3%
0.5/Trace
1
   7.1%
3
  50.0%
1+
6
  42.9%
1
  16.7%
2+
0
   0.0%
0
   0.0%
3+
0
   0.0%
0
   0.0%
4+
1
   7.1%
0
   0.0%
Day 57 Number Analyzed 14 participants 7 participants
0
5
  35.7%
2
  28.6%
0.5/Trace
5
  35.7%
2
  28.6%
1+
4
  28.6%
3
  42.9%
2+
0
   0.0%
0
   0.0%
3+
0
   0.0%
0
   0.0%
4+
0
   0.0%
0
   0.0%
Day 85 (end of study) Number Analyzed 15 participants 6 participants
0
2
  13.3%
1
  16.7%
0.5/Trace
6
  40.0%
3
  50.0%
1+
3
  20.0%
2
  33.3%
2+
3
  20.0%
0
   0.0%
3+
1
   6.7%
0
   0.0%
4+
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period
Hide Description

Visual acuity was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) eye charts under ETDRS conditions.

ETDRS best-corrected visual acuity was obtained in each eye separately under certified ETDRS conditions. This assessment was to be performed prior to pupil dilation. The number of letters read correctly (for each eye) was recorded.

BCVA is based on the number of letters read correctly.

Time Frame Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy 1 analysis set
Arm/Group Title LFG316 Conventional Therapy
Hide Arm/Group Description:
LFG316 administered intravitreally
Conventional treatment was selected by the investigator
Overall Number of Participants Analyzed 18 7
Mean (Standard Deviation)
Unit of Measure: letters
Day 2 Number Analyzed 15 participants 7 participants
72.5  (19.36) 76.1  (0.7)
Day 8 Number Analyzed 6 participants 1 participants
80.5  (11.69) 79.0  (79)
Day 15 Number Analyzed 16 participants 7 participants
68.8  (18.53) 78.9  (9.10)
Day 29 Number Analyzed 15 participants 7 participants
70.3  (19.39) 79.6  (9.47)
Day 43 Number Analyzed 14 participants 6 participants
65.5  (24.45) 77.3  (9.07)
Day 57 Number Analyzed 14 participants 7 participants
72.6  (14.79) 80.1  (10.35)
Day 85 Number Analyzed 15 participants 6 participants
72.1  (15.53) 76.7  (10.25)
5.Secondary Outcome
Title Number of Patients With Macular Edema in Study Eye - Treatment Period
Hide Description Macular edema is a sign of uveitis.
Time Frame Day 85 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy 1 analysis set
Arm/Group Title LFG316 Conventional Therapy
Hide Arm/Group Description:
LFG316 administered intravitreally
Conventional treatment was selected by the investigator
Overall Number of Participants Analyzed 10 3
Measure Type: Count of Participants
Unit of Measure: Participants
Day 2 Number Analyzed 6 participants 1 participants
2
  33.3%
1
 100.0%
Day 8 Number Analyzed 6 participants 1 participants
1
  16.7%
1
 100.0%
Day 15 Number Analyzed 7 participants 1 participants
3
  42.9%
0
   0.0%
Day 29 Number Analyzed 7 participants 1 participants
2
  28.6%
0
   0.0%
Day 43 Number Analyzed 7 participants 1 participants
2
  28.6%
0
   0.0%
Day 57 Number Analyzed 8 participants 2 participants
2
  25.0%
0
   0.0%
Day 85 (end of study) Number Analyzed 8 participants 3 participants
2
  25.0%
0
   0.0%
6.Secondary Outcome
Title Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period
Hide Description Chorioretinal lesions is a sign of uveitis.
Time Frame Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy 1 analysis set
Arm/Group Title LFG316 Conventional Therapy
Hide Arm/Group Description:
LFG316 administered intravitreally
Conventional treatment was selected by the investigator
Overall Number of Participants Analyzed 10 3
Measure Type: Count of Participants
Unit of Measure: Participants
Day 2 Number Analyzed 6 participants 1 participants
3
  50.0%
0
   0.0%
Day 8 Number Analyzed 6 participants 1 participants
2
  33.3%
0
   0.0%
Day 15 Number Analyzed 7 participants 1 participants
4
  57.1%
0
   0.0%
Day 29 Number Analyzed 7 participants 1 participants
5
  71.4%
0
   0.0%
Day 43 Number Analyzed 7 participants 1 participants
4
  57.1%
0
   0.0%
Day 57 Number Analyzed 8 participants 2 participants
5
  62.5%
1
  50.0%
Day 85 (end of study) Number Analyzed 8 participants 3 participants
4
  50.0%
1
  33.3%
7.Secondary Outcome
Title Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
Hide Description anterior chamber cells score (ACCS) with the scores being 0 (≤ 1 cell), 0.5 (1 to 5 aqueous cells), 1 (6 to 15 aqueous cells), 2 (16 to 25 aqueous cells), 3 (26 to 50 aqueous cells), 4 (>50 aqueous cells).
Time Frame Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy 1 analysis set
Arm/Group Title LFG316 Conventional Therapy
Hide Arm/Group Description:
LFG316 administered intravitreally
Conventional treatment was selected by the investigator
Overall Number of Participants Analyzed 10 3
Measure Type: Count of Participants
Unit of Measure: Participants
Day 2 Number Analyzed 7 participants 1 participants
0; <1 cell
2
  28.6%
0
   0.0%
0.5; 1-5 cells
4
  57.1%
1
 100.0%
1; 6-15 cells
1
  14.3%
0
   0.0%
2; 16-25 cells
0
   0.0%
0
   0.0%
3; 26-50 cells
0
   0.0%
0
   0.0%
4; >50 cells
0
   0.0%
0
   0.0%
Day 8 Number Analyzed 6 participants 1 participants
0; <1 cell
2
  33.3%
0
   0.0%
0.5; 1-5 cells
4
  66.7%
1
 100.0%
1; 6-15 cells
0
   0.0%
0
   0.0%
2; 16-25 cells
0
   0.0%
0
   0.0%
3; 26-50 cells
0
   0.0%
0
   0.0%
4; >50 cells
0
   0.0%
0
   0.0%
Day 15 Number Analyzed 8 participants 1 participants
0; <1 cell
3
  37.5%
1
 100.0%
0.5; 1-5 cells
4
  50.0%
0
   0.0%
1; 6-15 cells
1
  12.5%
0
   0.0%
2; 16-25 cells
0
   0.0%
0
   0.0%
3; 26-50 cells
0
   0.0%
0
   0.0%
4; >50 cells
0
   0.0%
0
   0.0%
Day 29 Number Analyzed 7 participants 1 participants
0; <1 cell
2
  28.6%
1
 100.0%
0.5; 1-5 cells
5
  71.4%
0
   0.0%
1; 6-15 cells
0
   0.0%
0
   0.0%
2; 16-25 cells
0
   0.0%
0
   0.0%
3; 26-50 cells
0
   0.0%
0
   0.0%
4; >50 cells
0
   0.0%
0
   0.0%
Day 43 Number Analyzed 7 participants 1 participants
0; <1 cell
5
  71.4%
1
 100.0%
0.5; 1-5 cells
0
   0.0%
0
   0.0%
1; 6-15 cells
1
  14.3%
0
   0.0%
2; 16-25 cells
1
  14.3%
0
   0.0%
3; 26-50 cells
0
   0.0%
0
   0.0%
4; >50 cells
0
   0.0%
0
   0.0%
Day 57 Number Analyzed 8 participants 2 participants
0; <1 cell
5
  62.5%
1
  50.0%
0.5; 1-5 cells
1
  12.5%
1
  50.0%
1; 6-15 cells
2
  25.0%
0
   0.0%
2; 16-25 cells
0
   0.0%
0
   0.0%
3; 26-50 cells
0
   0.0%
0
   0.0%
4; >50 cells
0
   0.0%
0
   0.0%
Day 85 Number Analyzed 9 participants 3 participants
0; <1 cell
4
  44.4%
3
 100.0%
0.5; 1-5 cells
5
  55.6%
0
   0.0%
1; 6-15 cells
0
   0.0%
0
   0.0%
2; 16-25 cells
0
   0.0%
0
   0.0%
3; 26-50 cells
0
   0.0%
0
   0.0%
4; >50 cells
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Participants With or Without Anti-LFG316 Antibodies
Hide Description

Blood will be collected at each visit for the profiling of serum drug concentrations. The summary of immunogenicity (IG) by visit . The immunogenicity data (presence/absence of anti-LFG316 antibodies [anti-drug antibodies]).

NO: No immunogenicity; YES: Positive immunogenicity.

Time Frame Throughout the study (treatment and extension period), up to day 271
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set: All patients in the safety analysis set with evaluable PK data and with no protocol deviations affecting PK data.
Arm/Group Title LFG316
Hide Arm/Group Description:
LFG316 administered intravitreally
Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 Number Analyzed 15 participants
participants with anti-LFG316 antibodies
3
  20.0%
participants without anti-LFG316 antibodies
12
  80.0%
Day 29 Number Analyzed 13 participants
participants with anti-LFG316 antibodies
3
  23.1%
participants without anti-LFG316 antibodies
10
  76.9%
Day 85 (end of study) Number Analyzed 11 participants
participants with anti-LFG316 antibodies
2
  18.2%
participants without anti-LFG316 antibodies
9
  81.8%
Day 169 Number Analyzed 2 participants
participants with anti-LFG316 antibodies
1
  50.0%
participants without anti-LFG316 antibodies
1
  50.0%
Day 253 Number Analyzed 1 participants
participants with anti-LFG316 antibodies
0
   0.0%
participants without anti-LFG316 antibodies
1
 100.0%
End of extension period Number Analyzed 1 participants
participants with anti-LFG316 antibodies
1
 100.0%
participants without anti-LFG316 antibodies
0
   0.0%
9.Secondary Outcome
Title Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period
Hide Description Percent change from baseline (using each patient’s pre-dose value as baseline) in total C5 concentrations.
Time Frame Day 2, 15, 29, 43, 57 and, 85 (end of the study)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) analysis set: All patients in the safety analysis set with EVALUABLE pharmacodynamics (PD) data (Total C5) and with no major protocol deviations that had an impact on PD data were included in the PD analysis set.
Arm/Group Title LFG316 Conventional Therapy
Hide Arm/Group Description:
LFG316 administered intravitreally
Conventional treatment was selected by the investigator
Overall Number of Participants Analyzed 15 7
Mean (Standard Deviation)
Unit of Measure: Percent change in C5
Day 2 Number Analyzed 15 participants 7 participants
6.80  (14.5) 1.02  (5.69)
Day 15 Number Analyzed 14 participants 7 participants
8.21  (15.3) -1.27  (19.7)
Day 29 Number Analyzed 15 participants 6 participants
10.6  (17.4) -8.33  (17.5)
Day 43 Number Analyzed 12 participants 5 participants
8.38  (13.4) 6.46  (18.6)
Day 57 Number Analyzed 15 participants 5 participants
6.73  (12.0) 5.98  (40.9)
Day 85 Number Analyzed 13 participants 7 participants
3.21  (22.1) 1.28  (31.3)
Time Frame Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LFG316 Conventional Therapy
Hide Arm/Group Description LF G316 administered intravitreally Conventional treatment was selected by the investigator
All-Cause Mortality
LFG316 Conventional Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/7 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
LFG316 Conventional Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   1/18 (5.56%)   0/7 (0.00%) 
Eye disorders     
Retinal detachment  1  1/18 (5.56%)  0/7 (0.00%) 
Retinopathy proliferative  1  1/18 (5.56%)  0/7 (0.00%) 
Infections and infestations     
Mycotic endophthalmitis  1  1/18 (5.56%)  0/7 (0.00%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LFG316 Conventional Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   11/18 (61.11%)   5/7 (71.43%) 
Eye disorders     
Cataract  1  1/18 (5.56%)  0/7 (0.00%) 
Conjunctival haemorrhage  1  4/18 (22.22%)  0/7 (0.00%) 
Conjunctival hyperaemia  1  1/18 (5.56%)  0/7 (0.00%) 
Cystoid macular oedema  1  1/18 (5.56%)  0/7 (0.00%) 
Dry eye  1  1/18 (5.56%)  1/7 (14.29%) 
Eye pain  1  1/18 (5.56%)  0/7 (0.00%) 
Hypotony of eye  1  0/18 (0.00%)  1/7 (14.29%) 
Macular fibrosis  1  1/18 (5.56%)  1/7 (14.29%) 
Ocular hypertension  1  0/18 (0.00%)  1/7 (14.29%) 
Uveitis  1  4/18 (22.22%)  0/7 (0.00%) 
Visual impairment  1  1/18 (5.56%)  0/7 (0.00%) 
Vitreous floaters  1  1/18 (5.56%)  0/7 (0.00%) 
Immune system disorders     
Hypersensitivity  1  1/18 (5.56%)  0/7 (0.00%) 
Infections and infestations     
Giardiasis  1  1/18 (5.56%)  0/7 (0.00%) 
Oral candidiasis  1  0/18 (0.00%)  1/7 (14.29%) 
Pharyngitis  1  0/18 (0.00%)  1/7 (14.29%) 
Sinusitis  1  1/18 (5.56%)  0/7 (0.00%) 
Tooth infection  1  0/18 (0.00%)  1/7 (14.29%) 
Urinary tract infection  1  0/18 (0.00%)  1/7 (14.29%) 
Viral upper respiratory tract infection  1  2/18 (11.11%)  1/7 (14.29%) 
Investigations     
Alanine aminotransferase increased  1  0/18 (0.00%)  1/7 (14.29%) 
Blood pressure increased  1  1/18 (5.56%)  0/7 (0.00%) 
Gamma-glutamyltransferase increased  1  0/18 (0.00%)  1/7 (14.29%) 
Intraocular pressure increased  1  3/18 (16.67%)  0/7 (0.00%) 
Optic nerve cup/disc ratio increased  1  1/18 (5.56%)  0/7 (0.00%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  1/18 (5.56%)  0/7 (0.00%) 
Nervous system disorders     
Headache  1  1/18 (5.56%)  1/7 (14.29%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  0/18 (0.00%)  1/7 (14.29%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: +1 862-778-8300
EMail: Novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01526889     History of Changes
Other Study ID Numbers: CLFG316A2204
2011-003254-90 ( EudraCT Number )
First Submitted: February 1, 2012
First Posted: February 6, 2012
Results First Submitted: August 15, 2018
Results First Posted: October 31, 2018
Last Update Posted: October 31, 2018