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Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis. (PREFERMS)

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ClinicalTrials.gov Identifier: NCT01623596
Recruitment Status : Completed
First Posted : June 20, 2012
Results First Posted : January 12, 2018
Last Update Posted : April 11, 2019
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
Condition Relapsing Remitting Multiple Sclerosis
Interventions Drug: Fingolimod
Drug: Disease Modifying therapy
Enrollment 881
Recruitment Details

62 Fingolimod arm participants discontinued: 57 discontinued before treatment switch, and 5 discontinued after treatment switch

100 MS-DMT arm participants discontinued before treatment switch: 57 discontinued before treatment switch, and 43 discontinued after treatment switch

Pre-assignment Details

Patient disposition was summarized on the Randomized Set.

Randomized Set (RS): consists of all participants who were assigned randomization numbers.

Arm/Group Title Fingolimod Disease Modifying Therapy
Hide Arm/Group Description fingolimod 0.5 mg once a day 2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
Period Title: Overall Study
Started 436 439
On Randomized Treatment 352 125
On Switched Treatment 22 214
Completed 374 339
Not Completed 62 100
Reason Not Completed
Abnormal laboratory values             2             0
Administrative problems             9             13
Adverse Event             20             29
Death             0             2
Lost to Follow-up             12             16
Withdrawal by Subject             13             31
Patient no longer requires study drug             1             0
Protocol Violation             0             6
Lack of Efficacy             5             3
Arm/Group Title Fingolimod Disease Modifying Therapy (MS_DMT) Total
Hide Arm/Group Description fingolimod 0.5 mg once a day 2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone) Total of all reporting groups
Overall Number of Baseline Participants 436 439 875
Hide Baseline Analysis Population Description
Randomized set (RS): consists of all patients who were assigned randomization numbers. The participants in this set were called randomized participants. This set was used to summarize participant disposition, demographic and baseline characteristics, and protocol deviation information. Participants were grouped according to randomized treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 436 participants 439 participants 875 participants
41.5  (10.84) 41.9  (10.39) 41.7  (10.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 436 participants 439 participants 875 participants
Female
311
  71.3%
329
  74.9%
640
  73.1%
Male
125
  28.7%
110
  25.1%
235
  26.9%
1.Primary Outcome
Title Participant Retention Rate Over 12 Months
Hide Description Comparison effectiveness of fingolimod versus approved first-line disease modifying therapies by measuring the rate of participant retention on randomized treatment over a 12-month period (Full analysis set)
Time Frame at 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set includes all the patients who received at least one dose of study medication and had information on the primary end point.
Arm/Group Title Fingolimod Disease Modifying Therapy (MS-DMT)
Hide Arm/Group Description:
fingolimod 0.5 mg once a day
2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
Overall Number of Participants Analyzed 436 439
Measure Type: Number
Unit of Measure: participants
352 125
2.Secondary Outcome
Title Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Hide Description

Reasons for discontinuation in participants treated with fingolimod vs. DMT over 12 months of treatment

Total discontinued (Primary reason): Fingolimod arm: 27, MS-DMT arm: 27 = 54 participants

Total discontinued (Secondary reason): Fingolimod arm: 257, MS-DMT arm: 256 = 513 participants

Throughout the study, investigators evaluated each patient for occurrence of randomized treatment discontinuation and determined the primary and secondary reasons for such discontinuation. At every visit, the investigator evaluated the patients and determined if they should continue on randomized treatment or change to alternative treatment. Treatment discontinuation was a clinically meaningful measure related to safety, efficacy, and tolerability over time, reflecting the therapeutic effectiveness of study treatment.

Time Frame at 12 months
Hide Outcome Measure Data
Hide Analysis Population Description

Randomized set (RS): consists of all patients who were assigned randomization numbers.

The patients in this set were called randomized patients. This set was used to summarize patient disposition, demographic and baseline characteristics, and protocol deviation information. Patients were grouped according to randomized treatment.

Arm/Group Title Fingolimod Disease Modifying Therapy (MS-DMT)
Hide Arm/Group Description:
fingolimod 0.5 mg once a day
2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
Overall Number of Participants Analyzed 436 439
Measure Type: Number
Unit of Measure: participants
Occurrence of relapse (Primary reason) 5 14
Disease activity present in MRI (Primary reason) 0 6
Injection site reaction (Primary reason) 0 61
Flu-like symptoms (Primary reason) 0 34
Lipoatrophy (Primary reason) 0 1
Depression (Primary reason) 1 4
Hepatic side effects (Primary reason) 7 3
Spasticity (Primary reason) 0 1
Infection (Primary reason) 0 0
Macular edema (Primary reason) 1 0
Bradycardia (Primary reason) 0 0
Needle phobia (Primary reason) 0 13
Inconvenient administration (Primary reason) 0 33
Frequency of injections (Primary reason) 0 29
Neutralizing antibodies present (Primary reason) 0 0
Other (Primary reason) 13 58
Occurrence of relapse (Secondary reason) 0 3
Disease activity present in MRI (Secondary reason) 2 5
Injection site reaction (Secondary reason) 0 40
Flu-like symptoms (Secondary reason) 1 16
Lipoatrophy (Secondary reason) 0 1
Depression (Secondary reason) 0 6
Hepatic side effects (Secondary reason) 5 0
Spasticity (Secondary reason) 1 2
Infection (Secondary reason) 0 0
Macular edema (Secondary reason) 1 0
Bradycardia (Secondary reason) 0 0
Needle phobia (Secondary reason) 0 18
Inconvenient administration (Secondary reason) 0 55
Frequency of injections (Secondary reason) 0 45
Neutralizing antibodies present (Secondary reason) 0 0
Other (Secondary reason) 17 65
3.Secondary Outcome
Title Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Oral Test) by Visit (Randomized Treatment / Randomized Phase)
Hide Description

Summary statistics Compare cognitive impairment measured by Symbol Digit Modalities Test (SDMT) scores. The SDMT score and its change from baseline value were summarized by visit. For the change from baseline values at each visit, ANCOVA adjusted for treatment naivety, corresponding baseline values, and age was performed for treatment comparisons

The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.

NOTE: Higher scores indicate better performance.

Time Frame baseline, 6 months, 12 months, and Last assessment which is either at Month 12 or at early discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set includes all the patients who received at least one dose of study medication and had information on the primary end point.
Arm/Group Title Fingolimod Disease Modifying Therapy (MS-DMT)
Hide Arm/Group Description:
fingolimod 0.5 mg once a day
2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
Overall Number of Participants Analyzed 433 428
Mean (Standard Deviation)
Unit of Measure: SDMT score
Baseline (n=76,70) Number Analyzed 76 participants 70 participants
52.00  (12.12) 51.60  (13.40)
Change at 6 months (n=70,64) Number Analyzed 70 participants 64 participants
2.20  (8.09) 0.20  (10.13)
Change at 12 months (n=58, 18) Number Analyzed 58 participants 18 participants
3.20  (7.09) 1.40  (8.33)
Change at Last assessment (n=73, 65) Number Analyzed 73 participants 65 participants
3.30  (7.77) 0.40  (9.47)
4.Secondary Outcome
Title Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Written Test) by Visit (Randomized Treatment / Randomized Phase)
Hide Description

Summary statistics Compare cognitive impairment measured by Symbol Digit Modalities Test (SDMT) scores. The SDMT score and its change from baseline value were summarized by visit. For the change from baseline values at each visit, ANCOVA adjusted for treatment naivety, corresponding baseline values, and age was performed for treatment comparisons

The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.

NOTE: Higher scores indicate better performance.

Time Frame baseline, 6 months, 12 months, Last assessment which is either at Month 12 or at early discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set includes all the patients who received at least one dose of study medication and had information on the primary end point.
Arm/Group Title Fingolimod Disease Modifying Therapy (MS-DMT)
Hide Arm/Group Description:
fingolimod 0.5 mg once a day
2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
Overall Number of Participants Analyzed 433 428
Mean (Standard Deviation)
Unit of Measure: SDMT score
Baseline (n=355,348) Number Analyzed 355 participants 348 participants
48.90  (18.26) 48.50  (20.19)
Change at 6 months (n=339,322) Number Analyzed 339 participants 322 participants
-0.50  (14.04) 0.70  (13.16)
Change at 12 months (n=282,105) Number Analyzed 282 participants 105 participants
0.70  (16.02) 0.40  (14.90)
Change at Last assessment (n=342, 324) Number Analyzed 342 participants 324 participants
0.80  (16.27) 0.70  (13.95)
5.Secondary Outcome
Title Percent Change From Baseline in Brain Volume From Month 12 to Last Visit (Randomized)
Hide Description Summary statistics for percent change from month 12 in brain volume by visit (Randomized treatment / randomized phase) in patients treated with fingolimod vs.DMTs as measured by MRI
Time Frame 12 months, and Last assessment which is either at Month 12 or at early discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set includes all the patients who received at least one dose of study medication and had information on the primary end point.
Arm/Group Title Fingolimod Disease Modifying Therapy
Hide Arm/Group Description:
fingolimod 0.5 mg once a day
2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
Overall Number of Participants Analyzed 433 428
Mean (Standard Deviation)
Unit of Measure: percent change in brain volume
Percent change at 12 months (n=323, 111) Number Analyzed 323 participants 111 participants
-0.396  (0.7825) -0.555  (0.7181)
Percent change at Last assessment (n=370, 246) Number Analyzed 370 participants 246 participants
-0.385  (0.7690) -0.420  (0.6423)
6.Secondary Outcome
Title Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
Hide Description Summary statistics for Medication Satisfaction Questionnaire[Question: “Overall, how satisfied are you with your current medication?”] (Randomized treatment / randomized phase): Fingolimod vs MS-DMT
Time Frame Baseline, 1 month, 3 months, 6 months, 9 months, at 12 months & Last assessment during randomized phase which is either at Month 12 or at early discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) includes all the patients who received at least one dose of study medication and had information on the primary end point.
Arm/Group Title Fingolimod Disease Modifying Therapy (DS-DMT)
Hide Arm/Group Description:
fingolimod 0.5 mg once a day
2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
Overall Number of Participants Analyzed 433 428
Measure Type: Number
Unit of Measure: participants
Baseline, Extremely dissatisfied 10 16
Baseline, Very dissatisfied 22 13
Baseline, Somewhat dissatisfied 29 39
Baseline, Neither dissatisfied nor satisfied 62 61
Baseline, Somewhat satisfied 35 46
Baseline, Very satisfied 42 31
Baseline, Extremely satisfied 14 17
Baseline, Missing 219 205
1 month, Extremely dissatisfied 8 29
1 month, Very dissatisfied 14 37
1 month, Somewhat dissatisfied 8 52
1 month, Neither dissatisfied nor satisfied 32 74
1 month, Somewhat satisfied 52 89
1 month, Very satisfied 161 97
1 month, Extremely satisfied 154 40
1 month, Missing 4 10
3 months, Extremely dissatisfied 5 19
3 months, Very dissatisfied 11 38
3 months, Somewhat dissatisfied 11 42
3 months, Neither dissatisfied nor satisfied 46 53
3 months, Somewhat satisfied 43 73
3 months, Very satisfied 153 91
3 months, Extremely satisfied 144 30
3 months, Missing 20 82
6 months, Extremely dissatisfied 8 9
6 months, Very dissatisfied 15 11
6 months, Somewhat dissatisfied 11 13
6 months, Neither dissatisfied nor satisfied 25 24
6 months, Somewhat satisfied 57 46
6 months, Very satisfied 130 67
6 months, Extremely satisfied 151 26
6 months, Missing 36 232
9 months, Extremely dissatisfied 7 4
9 months, Very dissatisfied 8 6
9 months, Somewhat dissatisfied 12 12
9 months, Neither dissatisfied nor satisfied 21 15
9 months, Somewhat satisfied 42 29
9 months, Very satisfied 135 58
9 months, Extremely satisfied 145 29
9 months, Missing 63 275
12 months, Extremely dissatisfied 7 3
12 months, Very dissatisfied 7 4
12 months, Somewhat dissatisfied 11 4
12 months, Neither dissatisfied nor satisfied 27 8
12 months, Somewhat satisfied 34 22
12 months, Very satisfied 115 60
12 months, Extremely satisfied 150 26
12 months, Missing 82 301
Last assessment, Extremely dissatisfied 14 46
Last assessment, Very dissatisfied 15 61
Last assessment, Somewhat dissatisfied 23 57
Last assessment,Neither dissatisfied nor satisfied 45 58
Last assessment, Somewhat satisfied 43 69
Last assessment, Very satisfied 128 94
Last assessment, Extremely satisfied 162 37
Last assessment, Missing 3 6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fingolimod MS DMT
Hide Arm/Group Description Fingolimod MS DMT
All-Cause Mortality
Fingolimod MS DMT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fingolimod MS DMT
Affected / at Risk (%) Affected / at Risk (%)
Total   29/433 (6.70%)   15/428 (3.50%) 
Blood and lymphatic system disorders     
Leukocytosis  1  0/433 (0.00%)  1/428 (0.23%) 
Cardiac disorders     
Acute myocardial infarction  1  1/433 (0.23%)  0/428 (0.00%) 
Atrioventricular block second degree  1  1/433 (0.23%)  0/428 (0.00%) 
Bradycardia  1  1/433 (0.23%)  0/428 (0.00%) 
Cardio-respiratory arrest  1  0/433 (0.00%)  1/428 (0.23%) 
Myocardial infarction  1  1/433 (0.23%)  0/428 (0.00%) 
Eye disorders     
Macular oedema  1  1/433 (0.23%)  0/428 (0.00%) 
Visual impairment  1  1/433 (0.23%)  0/428 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/433 (0.00%)  1/428 (0.23%) 
Abdominal pain lower  1  1/433 (0.23%)  0/428 (0.00%) 
Duodenal ulcer perforation  1  1/433 (0.23%)  0/428 (0.00%) 
Gastric ulcer  1  1/433 (0.23%)  0/428 (0.00%) 
Gastritis  1  1/433 (0.23%)  0/428 (0.00%) 
Gastrooesophageal reflux disease  1  0/433 (0.00%)  1/428 (0.23%) 
Jejunal ulcer  1  1/433 (0.23%)  0/428 (0.00%) 
Pneumoperitoneum  1  1/433 (0.23%)  0/428 (0.00%) 
Umbilical hernia  1  0/433 (0.00%)  1/428 (0.23%) 
General disorders     
Asthenia  1  1/433 (0.23%)  0/428 (0.00%) 
Localised oedema  1  1/433 (0.23%)  0/428 (0.00%) 
Systemic inflammatory response syndrome  1  1/433 (0.23%)  0/428 (0.00%) 
Hepatobiliary disorders     
Biliary colic  1  1/433 (0.23%)  0/428 (0.00%) 
Cholecystitis acute  1  0/433 (0.00%)  1/428 (0.23%) 
Cholelithiasis  1  0/433 (0.00%)  1/428 (0.23%) 
Infections and infestations     
Bacteraemia  1  1/433 (0.23%)  0/428 (0.00%) 
Campylobacter gastroenteritis  1  1/433 (0.23%)  0/428 (0.00%) 
Cellulitis  1  1/433 (0.23%)  0/428 (0.00%) 
Pneumonia  1  2/433 (0.46%)  0/428 (0.00%) 
Pneumonia influenzal  1  1/433 (0.23%)  0/428 (0.00%) 
Pyelonephritis acute  1  1/433 (0.23%)  0/428 (0.00%) 
Tooth abscess  1  1/433 (0.23%)  0/428 (0.00%) 
Viral infection  1  1/433 (0.23%)  0/428 (0.00%) 
Injury, poisoning and procedural complications     
Gastrointestinal stoma complication  1  1/433 (0.23%)  0/428 (0.00%) 
Intentional overdose  1  0/433 (0.00%)  1/428 (0.23%) 
Pubis fracture  1  1/433 (0.23%)  0/428 (0.00%) 
Seroma  1  1/433 (0.23%)  0/428 (0.00%) 
Spinal fracture  1  1/433 (0.23%)  0/428 (0.00%) 
Suture related complication  1  1/433 (0.23%)  0/428 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  2/433 (0.46%)  0/428 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  1/433 (0.23%)  0/428 (0.00%) 
Myopathy  1  1/433 (0.23%)  0/428 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant melanoma  1  1/433 (0.23%)  0/428 (0.00%) 
Nervous system disorders     
Dizziness  1  0/433 (0.00%)  1/428 (0.23%) 
Headache  1  1/433 (0.23%)  0/428 (0.00%) 
Hemiparesis  1  0/433 (0.00%)  1/428 (0.23%) 
Hypoaesthesia  1  0/433 (0.00%)  1/428 (0.23%) 
Mental impairment  1  0/433 (0.00%)  1/428 (0.23%) 
Multiple sclerosis relapse  1  5/433 (1.15%)  5/428 (1.17%) 
Optic neuritis  1  1/433 (0.23%)  0/428 (0.00%) 
Paraesthesia  1  1/433 (0.23%)  0/428 (0.00%) 
Sciatica  1  0/433 (0.00%)  1/428 (0.23%) 
Syncope  1  1/433 (0.23%)  0/428 (0.00%) 
Psychiatric disorders     
Agoraphobia  1  0/433 (0.00%)  1/428 (0.23%) 
Anxiety  1  1/433 (0.23%)  2/428 (0.47%) 
Depression  1  1/433 (0.23%)  0/428 (0.00%) 
Homicidal ideation  1  1/433 (0.23%)  0/428 (0.00%) 
Major depression  1  1/433 (0.23%)  0/428 (0.00%) 
Panic disorder  1  0/433 (0.00%)  1/428 (0.23%) 
Personality disorder  1  0/433 (0.00%)  1/428 (0.23%) 
Suicidal ideation  1  2/433 (0.46%)  0/428 (0.00%) 
Renal and urinary disorders     
Calculus urinary  1  1/433 (0.23%)  0/428 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/433 (0.00%)  1/428 (0.23%) 
Pleurisy  1  1/433 (0.23%)  0/428 (0.00%) 
Pneumothorax  1  1/433 (0.23%)  0/428 (0.00%) 
Surgical and medical procedures     
Abortion induced  1  1/433 (0.23%)  1/428 (0.23%) 
Vascular disorders     
Haematoma  1  1/433 (0.23%)  0/428 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fingolimod MS DMT
Affected / at Risk (%) Affected / at Risk (%)
Total   282/433 (65.13%)   291/428 (67.99%) 
Blood and lymphatic system disorders     
Lymphopenia  1  30/433 (6.93%)  1/428 (0.23%) 
Gastrointestinal disorders     
Diarrhoea  1  26/433 (6.00%)  5/428 (1.17%) 
Nausea  1  29/433 (6.70%)  22/428 (5.14%) 
General disorders     
Fatigue  1  49/433 (11.32%)  33/428 (7.71%) 
Influenza like illness  1  12/433 (2.77%)  64/428 (14.95%) 
Injection site erythema  1  0/433 (0.00%)  42/428 (9.81%) 
Injection site pain  1  0/433 (0.00%)  62/428 (14.49%) 
Injection site pruritus  1  0/433 (0.00%)  30/428 (7.01%) 
Injection site reaction  1  0/433 (0.00%)  50/428 (11.68%) 
Infections and infestations     
Nasopharyngitis  1  41/433 (9.47%)  22/428 (5.14%) 
Sinusitis  1  28/433 (6.47%)  21/428 (4.91%) 
Upper respiratory tract infection  1  27/433 (6.24%)  21/428 (4.91%) 
Urinary tract infection  1  23/433 (5.31%)  16/428 (3.74%) 
Investigations     
Lymphocyte count decreased  1  23/433 (5.31%)  0/428 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  30/433 (6.93%)  17/428 (3.97%) 
Back pain  1  29/433 (6.70%)  14/428 (3.27%) 
Pain in extremity  1  18/433 (4.16%)  23/428 (5.37%) 
Nervous system disorders     
Dizziness  1  31/433 (7.16%)  12/428 (2.80%) 
Headache  1  40/433 (9.24%)  41/428 (9.58%) 
Hypoaesthesia  1  23/433 (5.31%)  15/428 (3.50%) 
Migraine  1  22/433 (5.08%)  14/428 (3.27%) 
Paraesthesia  1  22/433 (5.08%)  17/428 (3.97%) 
Psychiatric disorders     
Anxiety  1  13/433 (3.00%)  24/428 (5.61%) 
Depression  1  26/433 (6.00%)  29/428 (6.78%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  25/433 (5.77%)  15/428 (3.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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: NCT01623596     History of Changes
Other Study ID Numbers: CFTY720DUS09
First Submitted: June 18, 2012
First Posted: June 20, 2012
Results First Submitted: July 13, 2016
Results First Posted: January 12, 2018
Last Update Posted: April 11, 2019