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Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis of Subjects Presenting With Clinically Isolated Syndrome (PreCISe)

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ClinicalTrials.gov Identifier: NCT00666224
Recruitment Status : Completed
First Posted : April 24, 2008
Results First Posted : June 13, 2012
Last Update Posted : June 25, 2012
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Interventions Drug: Glatiramer Acetate (DB)
Drug: Placebo
Drug: Glatiramer Acetate (OL)
Enrollment 481
Recruitment Details A clinically isolated syndrome (CIS) is a first neurological episode, lasting at least 24 hours, caused by inflammation/demyelination in one or more sites in the central nervous system (CNS.) Subjects were enrolled within 90 days of the event and randomized up to 32 days following screening.
Pre-assignment Details Six-hundred and nineteen (619) subjects were screened for this study; 138 subjects were screening failures, including one subject, randomized in error. This subject, who had a relapse between screening visit and baseline, never received any treatment, and is considered a screening failure.
Arm/Group Title Glatiramer Acetate Placebo (DB) to GA (OL)
Hide Arm/Group Description Glatiramer acetate (GA) 20 mg once daily by subcutaneous injection during the double-blind period. Following a pre-planned interim analysis, the Data Monitoring Committee (DMC) recommended that the double blind period be closed and participants moved into the Open Label (OL) period. Participants in this treatment arm continued taking glatiramer acetate 20 mg once daily by subcutaneous injection during the open-label (OL) period. Placebo matching glatiramer acetate given once daily by subcutaneous injection during the double-blind period (DB). Following a pre-planned interim analysis, the Data Monitoring Committee (DMC) recommended that the double blind period be closed and participants moved into the Open Label (OL) period. Glatiramer acetate (GA) given 20 mg once daily by subcutaneous injection during the open-label period (OL).
Period Title: Double-Blind
Started 243 238
Completed 198 [1] 211 [2]
Not Completed 45 27
Reason Not Completed
Adverse Event             15             5
Lost to Follow-up             2             2
Withdrawal by Subject             18             14
Physician Decision             0             3
Sponsor decision             1             0
Pregnancy             3             2
Noncompliance             1             0
Death             1             0
Undefined/Unknown             4             1
[1]
78 completed 3 years treatment, 66 converted to CDMS, 54 switched to OL as per DMC
[2]
55 completed 3 years treatment, 109 converted to CDMS, 47 switched to OL as per DMC
Period Title: Open-Label
Started 198 [1] 211
Completed 163 126
Not Completed 35 85
Reason Not Completed
Adverse Event             8             43
Lost to Follow-up             4             5
Withdrawal by Subject             12             25
Physician Decision             7             5
Pregnancy             1             5
Noncompliance             2             1
Undefined/Unknown             1             1
[1]
454 participants took at least one dose of GA including 45 who didn't continue into the OL.
Arm/Group Title Glatiramer Acetate (Double-blind Period) Placebo (Double-blind Period) Total
Hide Arm/Group Description Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period. Placebo matching GA once daily by subcutaneous injection during the double-blind period. Total of all reporting groups
Overall Number of Baseline Participants 243 238 481
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 243 participants 238 participants 481 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
243
 100.0%
238
 100.0%
481
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 243 participants 238 participants 481 participants
31.5  (6.9) 30.8  (7.0) 31.2  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 243 participants 238 participants 481 participants
Female
159
  65.4%
163
  68.5%
322
  66.9%
Male
84
  34.6%
75
  31.5%
159
  33.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 243 participants 238 participants 481 participants
Asian / Oriental 2 1 3
Black or African American 1 1 2
Caucasian 233 229 462
Hispanic 3 2 5
Other (not specified) 4 5 9
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 243 participants 238 participants 481 participants
Argentina 7 6 13
Australia 7 6 13
Austria 5 6 11
Denmark 5 6 11
Finland 10 10 20
France 11 11 22
Germany 32 31 63
Hungary 16 15 31
Italy 56 57 113
New Zealand 4 3 7
Norway 2 2 4
Romania 28 30 58
Spain 23 22 45
Sweden 2 0 2
United Kingdom 15 12 27
United States 20 21 41
Participants Who Used Corticosteroids for Initial Attack  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 243 participants 238 participants 481 participants
Used corticosteroids 149 159 308
Did not use corticosteroids 94 79 173
1.Primary Outcome
Title Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion
Hide Description Data from interim analysis with database lock on October 14, 2007. The time from randomization to conversion to CDMS as determined by the occurrence of a second clinical attack during the double-blind period. Poser criteria are: Two relapses and clinical evidence of two separate lesions; clinical evidence of one lesion and paraclinical evidence of another separate lesion. The two relapses must involve different parts of Central Nervous System and must be separated by a period of at least one month. Lesions are determined by Magnetic Resonance Imaging (MRI).
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) analysis set. The ITT consists of all participants who have been randomized and received at least one dose of glatiramer acetate or placebo.
Arm/Group Title Glatiramer Acetate (Double-blind Period) Placebo (Double-blind Period)
Hide Arm/Group Description:
Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
Placebo matching GA once daily by subcutaneous injection during the double-blind period.
Overall Number of Participants Analyzed 243 238
Mean (Standard Deviation)
Unit of Measure: days
657.85  (349.3) 590.54  (340.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glatiramer Acetate (Double-blind Period), Placebo (Double-blind Period)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments Type of unifocal presentation at baseline, past corticosteroid treatment (Yes/No) for the initial attack prior to randomization, and center effects as covariates.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
0.40 to 0.77
Estimation Comments [Not Specified]
2.Primary Outcome
Title Twenty-fifth Percentile (25%) Kaplan-Meier Estimates for Time From Randomization to Conversion to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period
Hide Description Data from interim analysis with database lock on October 14, 2007. Due to the number of participants in the glatiramer acetate group that converted to CDMS (see outcome #6), the 25th percentile was considered when running the Kaplan-Meier estimate for time to conversion to CDMS. Conversion to CDMS is determined by the occurrence of the second clinical attack.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) analysis set. The ITT consists of all participants who have been randomized and received at least one dose of glatiramer acetate or placebo.
Arm/Group Title Glatiramer Acetate (Double-blind Period) Placebo (Double-blind Period)
Hide Arm/Group Description:
Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
Placebo matching GA once daily by subcutaneous injection during the double-blind period.
Overall Number of Participants Analyzed 243 238
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: days
722 [1] 
(505 to NA)
336
(260 to 456)
[1]
Not able to be estimated due to small numbers of participants converting to CDMS
3.Secondary Outcome
Title Number of New T2 Brain Lesions Observed at the Last Observed Value (LOV) in the Double-blind Period
Hide Description Data from interim analysis with database lock on October 14, 2007. T2 lesions are brain lesions that show on magnetic resonance imaging (MRI) and are associated with multiple sclerosis. This outcome measures the number of new lesions at the last observed value. Last Observed Value (LOV) is defined as the last post baseline measurement taken on study drug but no more than 30 days after study drug cessation.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) analysis set. The ITT consists of all participants who have been randomized and received at least one dose of glatiramer acetate or placebo.
Arm/Group Title Glatiramer Acetate (Double-blind Period) Placebo (Double-blind Period)
Hide Arm/Group Description:
Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
Placebo matching GA once daily by subcutaneous injection during the double-blind period.
Overall Number of Participants Analyzed 243 238
Mean (Standard Deviation)
Unit of Measure: new T2 lesions
0.7  (1.7) 1.8  (3.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glatiramer Acetate (Double-blind Period), Placebo (Double-blind Period)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Quasi-Likelihood NB* Regression
Comments

*NB = Negative Binomial

Center and baseline number of enhancing lesions as covariates.

Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.29 to 0.61
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Last Observed Value (LOV) in T2 Brain Lesion Volume in the Double-blind Period
Hide Description Data from interim analysis with database lock on October 14, 2007. The difference in T2 brain lesion volume as observed in MRIs from baseline to the last observed value. Last Observed Value (LOV) is defined as the last post baseline measurement taken on study drug but no more than 30 days after study drug cessation.
Time Frame Day 0 (baseline), up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population for which data at both timepoints are available
Arm/Group Title Glatiramer Acetate (Double-blind Period) Placebo (Double-blind Period)
Hide Arm/Group Description:
Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
Placebo matching GA once daily by subcutaneous injection during the double-blind period.
Overall Number of Participants Analyzed 218 221
Mean (Standard Deviation)
Unit of Measure: ml
1.2  (2.6) 2.6  (3.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glatiramer Acetate (Double-blind Period), Placebo (Double-blind Period)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments [Not Specified]
Method ANCOVA
Comments Used log-transformed measurements comparing the adjusted geometric means of T2 volume. Center and baseline T2 volume used as covariates.
Method of Estimation Estimation Parameter Geometric means ratio
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.79 to 0.95
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage Change in Brain Volume From Baseline to the Last Observed Value (LOV) During the Double-blind Period Using the Structural Image Evaluation of Normalized Atrophy (SIENA) Technique
Hide Description Data from interim analysis with database lock on October 14, 2007. Brain volume was measured annually by magnetic resonance imaging (MRI) during the Double-blind period. Brain atrophy was measured by comparing the change in brain volume from baseline to the Last Observed Value (LOV). LOV is defined as the last post baseline measurement taken on study drug but no more than 30 days after study drug cessation. SIENA is a fully automated method of analyzing longitudinal brain change.
Time Frame Day 0 (baseline), up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population of participants with both baseline and last observed values.
Arm/Group Title Glatiramer Acetate (Double-blind Period) Placebo (Double-blind Period)
Hide Arm/Group Description:
Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
Placebo matching GA once daily by subcutaneous injection during the double-blind period.
Overall Number of Participants Analyzed 191 174
Mean (Standard Deviation)
Unit of Measure: percent change
-0.3  (0.6) -0.4  (0.7)
6.Secondary Outcome
Title Percentage of Participants Who Converted to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period
Hide Description Data from interim analysis with database lock on October 14, 2007. Conversion to CDMS as determined by the occurrence of a second clinical attack during the double-blind period. Poser criteria are: Two relapses and clinical evidence of two separate lesions; clinical evidence of one lesion and paraclinical evidence of another separate lesion. The two relapses must involve different parts of Central Nervous System and must be separated by a period of at least one month. Lesions are determined by Magnetic Resonance Imaging (MRI).
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) analysis set.
Arm/Group Title Glatiramer Acetate (Double-blind Period) Placebo (Double-blind Period)
Hide Arm/Group Description:
Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
Placebo matching GA once daily by subcutaneous injection during the double-blind period.
Overall Number of Participants Analyzed 243 238
Measure Type: Number
Unit of Measure: percentage of total participants
24.7 42.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glatiramer Acetate (Double-blind Period), Placebo (Double-blind Period)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Type of unifocal presentation, past corticosteroid treatment (Yes/No) for the initial attack prior to randomization and center effects as covariates.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
0.27 to 0.61
Estimation Comments [Not Specified]
Time Frame The double-blind period was up to three years. The entire study included the double-blind period (up to three years) and the open-label period (up to an additional two years).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (Double-blind Period) Glatiramer Acetate (Double-blind Period) Glatiramer Acetate (Entire Study)
Hide Arm/Group Description Placebo matching GA once daily by subcutaneous injection during the double-blind period. Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period. This subset of the GA treatment experience allows for comparison to the Placebo Double-blind Period data. Glatiramer acetate (GA) 20 mg once daily by subcutaneous injection. GA adverse experiences from both the double-blind and open-label periods are combined in this column.
All-Cause Mortality
Placebo (Double-blind Period) Glatiramer Acetate (Double-blind Period) Glatiramer Acetate (Entire Study)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Double-blind Period) Glatiramer Acetate (Double-blind Period) Glatiramer Acetate (Entire Study)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/238 (7.98%)   11/243 (4.53%)   44/454 (9.69%) 
Cardiac disorders       
Atrial fibrillation  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Palpitations  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Congenital, familial and genetic disorders       
Hydrocele  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Ear and labyrinth disorders       
Deafness  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Vertigo  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Gastrointestinal disorders       
Abdominal pain  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Abdominal tenderness  1  0/238 (0.00%)  1/243 (0.41%)  1/454 (0.22%) 
Haematemesis  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
General disorders       
Chest pain  1  0/238 (0.00%)  0/243 (0.00%)  2/454 (0.44%) 
Chills  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Feeling Hot  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Hepatobiliary disorders       
Cholecystitis  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Immune system disorders       
Anaphylactic Reaction  1  0/238 (0.00%)  0/243 (0.00%)  4/454 (0.88%) 
Anaphylactic shock  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Drug hypersensitivity  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Hypersensitivity  1  0/238 (0.00%)  1/243 (0.41%)  2/454 (0.44%) 
Infections and infestations       
Appendicitis  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Gastroenteritis viral  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Sinusitis  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Injury, poisoning and procedural complications       
Ankle fracture  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Avulsion fracture  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Contusion  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Fall  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Femoral neck fracture  1  0/238 (0.00%)  1/243 (0.41%)  1/454 (0.22%) 
Lumbar vertebral fracture  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Multiple drug overdose  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Post procedural haemorrhage  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Renal injury  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Investigations       
Hepatic enzyme increased  1  0/238 (0.00%)  0/243 (0.00%)  2/454 (0.44%) 
Platelet count decreased  1  0/238 (0.00%)  1/243 (0.41%)  1/454 (0.22%) 
Transaminases increased  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Visual field tests abnormal  1  0/238 (0.00%)  1/243 (0.41%)  1/454 (0.22%) 
Musculoskeletal and connective tissue disorders       
Fistula  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder transitional cell carcinoma  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Breast cancer  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Cholesteatoma  1  0/238 (0.00%)  1/243 (0.41%)  1/454 (0.22%) 
Rectal neoplasm  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Uterine leiomyoma  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Nervous system disorders       
Amnesia  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Aphasia  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Cluster headache  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Dizziness  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Facial palsy  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Intracranial venous sinus thrombosis  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Multiple sclerosis relapse  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Syncope  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Imminent abortion  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Psychiatric disorders       
Anxiety  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Completed suicide  1  0/238 (0.00%)  1/243 (0.41%)  1/454 (0.22%) 
Depression  1  1/238 (0.42%)  0/243 (0.00%)  1/454 (0.22%) 
Suicide attempt  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis  1  0/238 (0.00%)  1/243 (0.41%)  1/454 (0.22%) 
Renal colic  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Dyspnoea  1  0/238 (0.00%)  0/243 (0.00%)  2/454 (0.44%) 
Skin and subcutaneous tissue disorders       
Dermatitis allergic  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Urticaria  1  0/238 (0.00%)  1/243 (0.41%)  2/454 (0.44%) 
Surgical and medical procedures       
Abortion induced  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Anal fissure excision  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Appendicectomy  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Bladder neoplasm surgery  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Breast reconstruction  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Cholecystectomy  1  0/238 (0.00%)  1/243 (0.41%)  2/454 (0.44%) 
Cholesteatoma removal  1  0/238 (0.00%)  1/243 (0.41%)  1/454 (0.22%) 
Endometrial ablation  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Haemorrhoid operation  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Lipoma excision  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Nail operation  1  1/238 (0.42%)  0/243 (0.00%)  0/454 (0.00%) 
Resection of rectum  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Skin neoplasm excision  1  0/238 (0.00%)  1/243 (0.41%)  1/454 (0.22%) 
Tonsillectomy  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Vascular disorders       
Flushing  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Varicose vein  1  0/238 (0.00%)  0/243 (0.00%)  1/454 (0.22%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Placebo (Double-blind Period) Glatiramer Acetate (Double-blind Period) Glatiramer Acetate (Entire Study)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   165/238 (69.33%)   191/243 (78.60%)   352/454 (77.53%) 
Blood and lymphatic system disorders       
Lymphadenopathy  1  1/238 (0.42%)  13/243 (5.35%)  28/454 (6.17%) 
Cardiac disorders       
Tachycardia  1  0/238 (0.00%)  10/243 (4.12%)  25/454 (5.51%) 
Gastrointestinal disorders       
Diarrhoea  1  10/238 (4.20%)  11/243 (4.53%)  26/454 (5.73%) 
Nausea  1  12/238 (5.04%)  18/243 (7.41%)  34/454 (7.49%) 
Vomiting  1  5/238 (2.10%)  15/243 (6.17%)  29/454 (6.39%) 
General disorders       
Chest discomfort  1  1/238 (0.42%)  13/243 (5.35%)  25/454 (5.51%) 
Fatigue  1  22/238 (9.24%)  26/243 (10.70%)  40/454 (8.81%) 
Injection site erythema  1  15/238 (6.30%)  72/243 (29.63%)  140/454 (30.84%) 
Injection site haematoma  1  22/238 (9.24%)  16/243 (6.58%)  22/454 (4.85%) 
Injection site induration  1  3/238 (1.26%)  25/243 (10.29%)  45/454 (9.91%) 
Injection site pain  1  18/238 (7.56%)  54/243 (22.22%)  105/454 (23.13%) 
Injection site pruritus  1  4/238 (1.68%)  31/243 (12.76%)  58/454 (12.78%) 
Injection site reaction  1  5/238 (2.10%)  25/243 (10.29%)  41/454 (9.03%) 
Injection site swelling  1  6/238 (2.52%)  24/243 (9.88%)  53/454 (11.67%) 
Pyrexia  1  16/238 (6.72%)  13/243 (5.35%)  31/454 (6.83%) 
Infections and infestations       
Bronchitis  1  8/238 (3.36%)  12/243 (4.94%)  28/454 (6.17%) 
Influenza  1  34/238 (14.29%)  27/243 (11.11%)  55/454 (12.11%) 
Nasopharyngitis  1  49/238 (20.59%)  48/243 (19.75%)  94/454 (20.70%) 
Pharyngitis  1  19/238 (7.98%)  17/243 (7.00%)  32/454 (7.05%) 
Rhinitis  1  8/238 (3.36%)  14/243 (5.76%)  23/454 (5.07%) 
Sinusitis  1  12/238 (5.04%)  15/243 (6.17%)  30/454 (6.61%) 
Tonsillitis  1  7/238 (2.94%)  11/243 (4.53%)  23/454 (5.07%) 
Upper respiratory tract infection  1  16/238 (6.72%)  22/243 (9.05%)  41/454 (9.03%) 
Urinary tract infection  1  11/238 (4.62%)  10/243 (4.12%)  33/454 (7.27%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  8/238 (3.36%)  9/243 (3.70%)  29/454 (6.39%) 
Back pain  1  19/238 (7.98%)  25/243 (10.29%)  47/454 (10.35%) 
Pain in extremity  1  17/238 (7.14%)  13/243 (5.35%)  28/454 (6.17%) 
Nervous system disorders       
Headache  1  43/238 (18.07%)  54/243 (22.22%)  80/454 (17.62%) 
Paraesthesia  1  18/238 (7.56%)  21/243 (8.64%)  37/454 (8.15%) 
Psychiatric disorders       
Anxiety  1  12/238 (5.04%)  15/243 (6.17%)  30/454 (6.61%) 
Depression  1  14/238 (5.88%)  17/243 (7.00%)  35/454 (7.71%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  14/238 (5.88%)  19/243 (7.82%)  30/454 (6.61%) 
Dyspnoea  1  3/238 (1.26%)  18/243 (7.41%)  48/454 (10.57%) 
Skin and subcutaneous tissue disorders       
Erythema  1  4/238 (1.68%)  11/243 (4.53%)  28/454 (6.17%) 
Vascular disorders       
Flushing  1  1/238 (0.42%)  15/243 (6.17%)  31/454 (6.83%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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.

Should the investigator wish to publish the results of this study, he/she agrees to provide Teva with a manuscript for review 60 days prior to submission for publication. Teva retains the right to delete confidential information and to object to suggest publication and/or its timing (at the Company's sole discretion).

If Teva chooses to publish this study a copy will be provided to the investigator at least 30 days prior to the expected date of submission to the intended publisher.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yossi Gilgun, PhD, Global Clinical Leader
Organization: Teva Pharmaceutical Industries, Ltd.
Phone: 972-9-863-1491
EMail: yossi.gilgun@teva.co.il
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00666224     History of Changes
Other Study ID Numbers: GA 9010
First Submitted: April 22, 2008
First Posted: April 24, 2008
Results First Submitted: May 3, 2012
Results First Posted: June 13, 2012
Last Update Posted: June 25, 2012