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Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness

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ClinicalTrials.gov Identifier: NCT00203021
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : July 18, 2019
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products R&D, Inc. )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Relapsing-Remitting Multiple Sclerosis
Intervention Drug: Glatiramer acetate
Enrollment 208
Recruitment Details Participants who participated in both or either Studies 01-9001 (double-blind [DB] placebo-controlled study) and 01-9001E (DB extension study) were eligible to enter into this open-label extension study. Note that the 01-9001 and 01-9001E studies predate NCT assignments.
Pre-assignment Details A total of 209 participants were screened; 208 participants met entry criteria and were enrolled in this study.
Arm/Group Title Glatiramer Acetate: Delayed Start Glatiramer Acetate: Early Start
Hide Arm/Group Description Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 milligrams (mg) subcutaneous (SC) injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg three times weekly (TIW). The treatment continued for up to 288 months. Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
Period Title: Overall Study
Started 107 101
Received at Least 1 Dose of Study Drug 107 101
Completed 28 24
Not Completed 79 77
Reason Not Completed
Death             4             1
Adverse Event             10             5
Withdrawal by Subject             45             48
Lost to Follow-up             9             7
Other than specified             11             16
Arm/Group Title Glatiramer Acetate: Delayed Start Glatiramer Acetate: Early Start Total
Hide Arm/Group Description Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months. Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months. Total of all reporting groups
Overall Number of Baseline Participants 107 101 208
Hide Baseline Analysis Population Description
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 101 participants 208 participants
36.9  (6.57) 37.2  (5.79) 37.1  (6.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 101 participants 208 participants
Female
82
  76.6%
72
  71.3%
154
  74.0%
Male
25
  23.4%
29
  28.7%
54
  26.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 101 participants 208 participants
Hispanic or Latino
2
   1.9%
0
   0.0%
2
   1.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
105
  98.1%
101
 100.0%
206
  99.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 101 participants 208 participants
White
101
  94.4%
97
  96.0%
198
  95.2%
Black
2
   1.9%
3
   3.0%
5
   2.4%
American Indian or Alaskan Native
1
   0.9%
1
   1.0%
2
   1.0%
Other
1
   0.9%
0
   0.0%
1
   0.5%
Missing
2
   1.9%
0
   0.0%
2
   1.0%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. Any AEs included both serious and non-serious AEs. A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in Reported AE section.
Time Frame Baseline up to Month 288
Hide Outcome Measure Data
Hide Analysis Population Description
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
Arm/Group Title Glatiramer Acetate: Delayed Start Glatiramer Acetate: Early Start
Hide Arm/Group Description:
Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
Overall Number of Participants Analyzed 107 101
Measure Type: Number
Unit of Measure: participants
Any AEs 107 100
Serious AEs 44 38
2.Primary Outcome
Title Change From Baseline in Kurtzke Expanded Disability Status Scale (EDSS) Score at Month 288
Hide Description The EDSS uses an ordinal scale to assess neurologic impairment in Multiple Sclerosis based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral) and an ambulation score were combined to determine the total EDSS score, ranging from 0 (normal) to 10 (death due to Multiple Sclerosis).
Time Frame Baseline, Month 288
Hide Outcome Measure Data
Hide Analysis Population Description
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
Arm/Group Title Glatiramer Acetate: Delayed Start Glatiramer Acetate: Early Start
Hide Arm/Group Description:
Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
Overall Number of Participants Analyzed 28 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 2.34  (1.599) 2.23  (1.406)
Change at Month 288 1.64  (1.962) 1.06  (1.896)
Time Frame Baseline up to Month 288
Adverse Event Reporting Description 01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
 
Arm/Group Title Glatiramer Acetate: Delayed Start Glatiramer Acetate: Early Start
Hide Arm/Group Description Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months. Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
All-Cause Mortality
Glatiramer Acetate: Delayed Start Glatiramer Acetate: Early Start
Affected / at Risk (%) Affected / at Risk (%)
Total   4/107 (3.74%)      1/101 (0.99%)    
Hide Serious Adverse Events
Glatiramer Acetate: Delayed Start Glatiramer Acetate: Early Start
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/107 (41.12%)      38/101 (37.62%)    
Blood and lymphatic system disorders     
Anaemia  1  0/107 (0.00%)  0 2/101 (1.98%)  2
Cardiac disorders     
Arteriosclerosis coronary artery  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Atrial fibrillation  1  0/107 (0.00%)  0 3/101 (2.97%)  3
Atrioventricular block  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Bundle branch block left  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Coronary artery disease  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Coronary artery occlusion  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Myocardial infarction  1  2/107 (1.87%)  3 0/101 (0.00%)  0
Pericarditis  1  0/107 (0.00%)  0 1/101 (0.99%)  2
Supraventricular tachycardia  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Congenital, familial and genetic disorders     
Diverticulitis Meckel's  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Ear and labyrinth disorders     
Meniere's disease  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Vertigo  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Endocrine disorders     
Thyroid cyst  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Anal incontinence  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Colitis ulcerative  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Constipation  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Diarrhoea  1  1/107 (0.93%)  1 2/101 (1.98%)  2
Gastric ulcer  1  1/107 (0.93%)  1 1/101 (0.99%)  1
Gastric varices haemorrhage  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Gastrointestinal haemorrhage  1  1/107 (0.93%)  2 0/101 (0.00%)  0
Gastrointestinal inflammation  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Hiatus hernia  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Ileus  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Ileus paralytic  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Large intestinal stenosis  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Large intestine polyp  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Nausea  1  1/107 (0.93%)  1 1/101 (0.99%)  1
Oesophageal spasm  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Oesophageal varices haemorrhage  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Oesophagitis  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Pancreatitis  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Small intestinal obstruction  1  0/107 (0.00%)  0 2/101 (1.98%)  2
Vomiting  1  1/107 (0.93%)  1 2/101 (1.98%)  2
General disorders     
Adhesion  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Asthenia  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Chest discomfort  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Chest pain  1  2/107 (1.87%)  3 5/101 (4.95%)  6
Complication associated with device  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Death  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Facial pain  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Feeling abnormal  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Haemorrhagic cyst  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Influenza like illness  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Injection site inflammation  1  1/107 (0.93%)  2 0/101 (0.00%)  0
Non-cardiac chest pain  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Peripheral swelling  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Pyrexia  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Strangulated hernia  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Hepatobiliary disorders     
Biliary cirrhosis primary  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Cholecystitis  1  2/107 (1.87%)  2 1/101 (0.99%)  1
Cholelithiasis  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Infections and infestations     
Abscess limb  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Appendicitis  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Atypical pneumonia  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Bronchitis  1  0/107 (0.00%)  0 1/101 (0.99%)  5
Catheter site abscess  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Cellulitis  1  2/107 (1.87%)  2 0/101 (0.00%)  0
Cystitis  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Gastroenteritis  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Gastroenteritis viral  1  1/107 (0.93%)  1 1/101 (0.99%)  1
Infection  1  0/107 (0.00%)  0 2/101 (1.98%)  2
Kidney infection  1  0/107 (0.00%)  0 2/101 (1.98%)  2
Mastitis  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Meningitis aseptic  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Peritonitis  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Pneumonia  1  2/107 (1.87%)  2 2/101 (1.98%)  2
Post procedural sepsis  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Pyelonephritis  1  1/107 (0.93%)  1 1/101 (0.99%)  1
Sepsis  1  2/107 (1.87%)  3 0/101 (0.00%)  0
Septic shock  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Urinary tract infection  1  5/107 (4.67%)  7 4/101 (3.96%)  4
Wound infection fungal  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Injury, poisoning and procedural complications     
Accidental overdose  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Biliary anastomosis complication  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Concussion  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Contusion  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Craniocerebral injury  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Failure to anastomose  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Fall  1  2/107 (1.87%)  2 0/101 (0.00%)  0
Femur fracture  1  3/107 (2.80%)  3 1/101 (0.99%)  1
Fibula fracture  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Forearm fracture  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Gastrointestinal injury  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Hip fracture  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Intentional overdose  1  1/107 (0.93%)  1 2/101 (1.98%)  2
Laceration  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Limb injury  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Overdose  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Pneumothorax traumatic  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Post lumbar puncture syndrome  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Procedural pain  1  1/107 (0.93%)  1 1/101 (0.99%)  1
Procedural pneumothorax  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Rib fracture  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Road traffic accident  1  2/107 (1.87%)  3 1/101 (0.99%)  2
Spinal fracture  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Sternal fracture  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Thoracic vertebral fracture  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Tibia fracture  1  3/107 (2.80%)  3 1/101 (0.99%)  1
Toxicity to various agents  1  0/107 (0.00%)  0 2/101 (1.98%)  2
Investigations     
Cardiac output decreased  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Weight decreased  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Metabolism and nutrition disorders     
Dehydration  1  5/107 (4.67%)  6 2/101 (1.98%)  3
Hypercholesterolaemia  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Hyponatraemia  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Malnutrition  1  1/107 (0.93%)  1 1/101 (0.99%)  1
Obesity  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Musculoskeletal and connective tissue disorders     
Arthritis  1  0/107 (0.00%)  0 1/101 (0.99%)  2
Back pain  1  3/107 (2.80%)  3 1/101 (0.99%)  2
Intervertebral disc protrusion  1  1/107 (0.93%)  2 0/101 (0.00%)  0
Joint stiffness  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Muscle spasms  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Muscular weakness  1  1/107 (0.93%)  1 2/101 (1.98%)  2
Musculoskeletal chest pain  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Osteoarthritis  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Spinal osteoarthritis  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acoustic neuroma  1  2/107 (1.87%)  2 0/101 (0.00%)  0
Basal cell carcinoma  1  0/107 (0.00%)  0 1/101 (0.99%)  3
Breast cancer  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Leiomyoma  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Lung carcinoma cell type unspecified stage III  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Ovarian neoplasm  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Prostate cancer  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Uterine leiomyoma  1  2/107 (1.87%)  2 4/101 (3.96%)  5
Nervous system disorders     
Cerebrovascular accident  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Depressed level of consciousness  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Dizziness  1  2/107 (1.87%)  2 0/101 (0.00%)  0
Drug withdrawal convulsions  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Generalised tonic-clonic seizure  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Loss of consciousness  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Multiple sclerosis  1  1/107 (0.93%)  1 1/101 (0.99%)  1
Multiple sclerosis relapse  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Muscle spasticity  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Sciatica  1  0/107 (0.00%)  0 2/101 (1.98%)  2
Seizure  1  3/107 (2.80%)  3 0/101 (0.00%)  0
Sensory loss  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Syncope  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Transient global amnesia  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Trigeminal neuralgia  1  2/107 (1.87%)  2 0/101 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  2/107 (1.87%)  2 1/101 (0.99%)  1
Pregnancy  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Psychiatric disorders     
Anger  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Anxiety  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Confusional state  1  2/107 (1.87%)  2 0/101 (0.00%)  0
Depression  1  0/107 (0.00%)  0 5/101 (4.95%)  8
Panic attack  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Psychotic disorder  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Suicidal ideation  1  0/107 (0.00%)  0 2/101 (1.98%)  2
Suicide attempt  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Renal and urinary disorders     
Calculus urethral  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Neurogenic bladder  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Renal failure  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Renal pain  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Urethral stenosis  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Urinary incontinence  1  1/107 (0.93%)  1 1/101 (0.99%)  1
Urinary retention  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Reproductive system and breast disorders     
Breast disorder  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Cystocele  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Menorrhagia  1  2/107 (1.87%)  3 0/101 (0.00%)  0
Ovarian cyst  1  1/107 (0.93%)  1 1/101 (0.99%)  1
Pelvic adhesions  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Pelvic pain  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Rectocele  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Uterine haemorrhage  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Vaginal haemorrhage  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Haemothorax  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Hypoxia  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Pneumonia aspiration  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Reflux laryngitis  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Respiratory failure  1  1/107 (0.93%)  1 1/101 (0.99%)  1
Tonsillar hypertrophy  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  1/107 (0.93%)  1 1/101 (0.99%)  1
Swelling face  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Surgical and medical procedures     
Appendicectomy  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Bladder repair  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Central venous catheterisation  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Cholecystectomy  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Femoral hernia repair  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Hip arthroplasty  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Hysterectomy  1  2/107 (1.87%)  2 2/101 (1.98%)  2
Hysterosalpingo-oophorectomy  1  1/107 (0.93%)  1 1/101 (0.99%)  1
Knee arthroplasty  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Small intestinal resection  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Spinal laminectomy  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Vascular disorders     
Arteriosclerosis  1  1/107 (0.93%)  2 0/101 (0.00%)  0
Deep vein thrombosis  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Flushing  1  1/107 (0.93%)  1 0/101 (0.00%)  0
Haematoma  1  0/107 (0.00%)  0 1/101 (0.99%)  1
Hypotension  1  1/107 (0.93%)  1 1/101 (0.99%)  2
Orthostatic hypotension  1  0/107 (0.00%)  0 1/101 (0.99%)  1
1
Term from vocabulary, MedDRA v19.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Glatiramer Acetate: Delayed Start Glatiramer Acetate: Early Start
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   107/107 (100.00%)      100/101 (99.01%)    
Blood and lymphatic system disorders     
Anaemia  1  11/107 (10.28%)  11 9/101 (8.91%)  9
Lymphadenopathy  1  10/107 (9.35%)  23 7/101 (6.93%)  57
Cardiac disorders     
Palpitations  1  12/107 (11.21%)  31 9/101 (8.91%)  28
Tachycardia  1  6/107 (5.61%)  13 8/101 (7.92%)  21
Ear and labyrinth disorders     
Ear pain  1  7/107 (6.54%)  10 11/101 (10.89%)  14
Tinnitus  1  11/107 (10.28%)  16 10/101 (9.90%)  14
Vertigo  1  18/107 (16.82%)  28 16/101 (15.84%)  31
Endocrine disorders     
Hypothyroidism  1  4/107 (3.74%)  4 6/101 (5.94%)  7
Eye disorders     
Diplopia  1  14/107 (13.08%)  18 9/101 (8.91%)  12
Dry eye  1  6/107 (5.61%)  8 2/101 (1.98%)  3
Eye pain  1  6/107 (5.61%)  11 16/101 (15.84%)  32
Vision blurred  1  24/107 (22.43%)  37 19/101 (18.81%)  33
Visual acuity reduced  1  4/107 (3.74%)  5 9/101 (8.91%)  12
Visual impairment  1  13/107 (12.15%)  16 9/101 (8.91%)  11
Gastrointestinal disorders     
Abdominal discomfort  1  13/107 (12.15%)  19 13/101 (12.87%)  16
Abdominal pain  1  10/107 (9.35%)  21 16/101 (15.84%)  25
Abdominal pain upper  1  8/107 (7.48%)  11 6/101 (5.94%)  6
Anal incontinence  1  11/107 (10.28%)  18 12/101 (11.88%)  28
Constipation  1  23/107 (21.50%)  38 20/101 (19.80%)  30
Defaecation urgency  1  5/107 (4.67%)  11 6/101 (5.94%)  8
Diarrhoea  1  25/107 (23.36%)  45 27/101 (26.73%)  48
Dyspepsia  1  12/107 (11.21%)  22 10/101 (9.90%)  14
Dysphagia  1  11/107 (10.28%)  17 8/101 (7.92%)  16
Gastritis  1  6/107 (5.61%)  9 2/101 (1.98%)  2
Gastrooesophageal reflux disease  1  12/107 (11.21%)  15 14/101 (13.86%)  16
Hiatus hernia  1  1/107 (0.93%)  4 6/101 (5.94%)  7
Large intestine polyp  1  6/107 (5.61%)  6 5/101 (4.95%)  5
Nausea  1  31/107 (28.97%)  66 24/101 (23.76%)  59
Toothache  1  6/107 (5.61%)  8 6/101 (5.94%)  9
Vomiting  1  16/107 (14.95%)  22 14/101 (13.86%)  28
General disorders     
Asthenia  1  8/107 (7.48%)  9 13/101 (12.87%)  19
Chest discomfort  1  17/107 (15.89%)  64 13/101 (12.87%)  66
Chest pain  1  12/107 (11.21%)  15 6/101 (5.94%)  9
Chills  1  9/107 (8.41%)  26 5/101 (4.95%)  6
Fatigue  1  58/107 (54.21%)  145 59/101 (58.42%)  159
Feeling hot  1  5/107 (4.67%)  6 6/101 (5.94%)  11
Gait disturbance  1  14/107 (13.08%)  20 18/101 (17.82%)  25
Ill-defined disorder  1  8/107 (7.48%)  9 3/101 (2.97%)  4
Injection site bruising  1  11/107 (10.28%)  18 6/101 (5.94%)  9
Injection site erythema  1  68/107 (63.55%)  87 33/101 (32.67%)  40
Injection site haemorrhage  1  8/107 (7.48%)  12 4/101 (3.96%)  5
Injection site induration  1  20/107 (18.69%)  28 6/101 (5.94%)  18
Injection site mass  1  26/107 (24.30%)  68 14/101 (13.86%)  24
Injection site pain  1  52/107 (48.60%)  111 15/101 (14.85%)  19
Injection site pruritus  1  25/107 (23.36%)  29 11/101 (10.89%)  15
Injection site reaction  1  8/107 (7.48%)  11 4/101 (3.96%)  5
Injection site swelling  1  34/107 (31.78%)  43 11/101 (10.89%)  12
Injection site urticaria  1  12/107 (11.21%)  28 8/101 (7.92%)  8
Injection site warmth  1  10/107 (9.35%)  14 4/101 (3.96%)  4
Oedema peripheral  1  10/107 (9.35%)  13 7/101 (6.93%)  10
Pain  1  16/107 (14.95%)  31 8/101 (7.92%)  12
Peripheral swelling  1  13/107 (12.15%)  16 8/101 (7.92%)  10
Pyrexia  1  11/107 (10.28%)  23 15/101 (14.85%)  21
Immune system disorders     
Hypersensitivity  1  8/107 (7.48%)  9 8/101 (7.92%)  11
Seasonal allergy  1  15/107 (14.02%)  24 13/101 (12.87%)  22
Infections and infestations     
Bronchitis  1  20/107 (18.69%)  35 22/101 (21.78%)  44
Cellulitis  1  7/107 (6.54%)  9 6/101 (5.94%)  7
Conjunctivitis  1  8/107 (7.48%)  13 5/101 (4.95%)  5
Cystitis  1  13/107 (12.15%)  24 5/101 (4.95%)  5
Ear infection  1  11/107 (10.28%)  13 9/101 (8.91%)  12
Fungal infection  1  9/107 (8.41%)  11 13/101 (12.87%)  27
Gastroenteritis  1  7/107 (6.54%)  7 5/101 (4.95%)  7
Gastroenteritis viral  1  17/107 (15.89%)  22 16/101 (15.84%)  24
Herpes zoster  1  7/107 (6.54%)  12 10/101 (9.90%)  12
Influenza  1  33/107 (30.84%)  55 25/101 (24.75%)  40
Nasopharyngitis  1  32/107 (29.91%)  98 28/101 (27.72%)  74
Oral herpes  1  7/107 (6.54%)  12 6/101 (5.94%)  15
Pharyngitis  1  6/107 (5.61%)  9 4/101 (3.96%)  4
Pharyngitis streptococcal  1  9/107 (8.41%)  9 7/101 (6.93%)  7
Pneumonia  1  9/107 (8.41%)  10 9/101 (8.91%)  11
Sinusitis  1  37/107 (34.58%)  115 37/101 (36.63%)  108
Tooth abscess  1  10/107 (9.35%)  10 5/101 (4.95%)  7
Tooth infection  1  3/107 (2.80%)  5 9/101 (8.91%)  10
Upper respiratory tract infection  1  66/107 (61.68%)  283 64/101 (63.37%)  282
Urinary tract infection  1  51/107 (47.66%)  281 48/101 (47.52%)  248
Vaginal infection  1  5/107 (4.67%)  13 7/101 (6.93%)  7
Vulvovaginal mycotic infection  1  9/107 (8.41%)  19 11/101 (10.89%)  18
Injury, poisoning and procedural complications     
Contusion  1  27/107 (25.23%)  49 20/101 (19.80%)  28
Fall  1  31/107 (28.97%)  78 35/101 (34.65%)  79
Foot fracture  1  15/107 (14.02%)  21 13/101 (12.87%)  15
Hand fracture  1  9/107 (8.41%)  9 6/101 (5.94%)  7
Joint injury  1  3/107 (2.80%)  3 9/101 (8.91%)  10
Laceration  1  13/107 (12.15%)  17 13/101 (12.87%)  16
Ligament sprain  1  11/107 (10.28%)  13 12/101 (11.88%)  15
Muscle strain  1  9/107 (8.41%)  11 13/101 (12.87%)  13
Post procedural complication  1  8/107 (7.48%)  12 3/101 (2.97%)  8
Procedural pain  1  14/107 (13.08%)  31 13/101 (12.87%)  24
Rib fracture  1  4/107 (3.74%)  4 7/101 (6.93%)  8
Road traffic accident  1  6/107 (5.61%)  8 6/101 (5.94%)  6
Skin abrasion  1  8/107 (7.48%)  15 7/101 (6.93%)  8
Investigations     
Weight decreased  1  7/107 (6.54%)  15 4/101 (3.96%)  6
Metabolism and nutrition disorders     
Hypercholesterolaemia  1  9/107 (8.41%)  13 14/101 (13.86%)  16
Musculoskeletal and connective tissue disorders     
Arthralgia  1  32/107 (29.91%)  60 34/101 (33.66%)  91
Arthritis  1  4/107 (3.74%)  5 7/101 (6.93%)  9
Back pain  1  34/107 (31.78%)  82 36/101 (35.64%)  74
Intervertebral disc protrusion  1  3/107 (2.80%)  8 6/101 (5.94%)  8
Joint swelling  1  7/107 (6.54%)  11 6/101 (5.94%)  9
Limb discomfort  1  4/107 (3.74%)  4 10/101 (9.90%)  16
Muscle spasms  1  20/107 (18.69%)  35 24/101 (23.76%)  47
Muscle tightness  1  7/107 (6.54%)  12 3/101 (2.97%)  3
Muscular weakness  1  45/107 (42.06%)  81 38/101 (37.62%)  78
Musculoskeletal pain  1  18/107 (16.82%)  27 12/101 (11.88%)  16
Musculoskeletal stiffness  1  17/107 (15.89%)  35 19/101 (18.81%)  34
Myalgia  1  6/107 (5.61%)  6 9/101 (8.91%)  15
Neck pain  1  17/107 (15.89%)  25 8/101 (7.92%)  13
Osteopenia  1  6/107 (5.61%)  6 6/101 (5.94%)  7
Osteoporosis  1  9/107 (8.41%)  12 9/101 (8.91%)  11
Pain in extremity  1  33/107 (30.84%)  72 37/101 (36.63%)  73
Tendonitis  1  6/107 (5.61%)  9 5/101 (4.95%)  11
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma  1  6/107 (5.61%)  7 4/101 (3.96%)  4
Nervous system disorders     
Amnesia  1  5/107 (4.67%)  10 8/101 (7.92%)  14
Balance disorder  1  23/107 (21.50%)  50 27/101 (26.73%)  47
Burning sensation  1  9/107 (8.41%)  17 10/101 (9.90%)  28
Cognitive disorder  1  8/107 (7.48%)  11 6/101 (5.94%)  8
Coordination abnormal  1  5/107 (4.67%)  6 7/101 (6.93%)  11
Dizziness  1  39/107 (36.45%)  85 29/101 (28.71%)  56
Dysaesthesia  1  7/107 (6.54%)  8 7/101 (6.93%)  10
Dysarthria  1  10/107 (9.35%)  19 9/101 (8.91%)  12
Headache  1  46/107 (42.99%)  89 40/101 (39.60%)  96
Hemiparesis  1  6/107 (5.61%)  7 8/101 (7.92%)  10
Hyperaesthesia  1  6/107 (5.61%)  19 6/101 (5.94%)  6
Hypoaesthesia  1  41/107 (38.32%)  97 42/101 (41.58%)  106
Memory impairment  1  12/107 (11.21%)  20 9/101 (8.91%)  15
Migraine  1  9/107 (8.41%)  14 13/101 (12.87%)  25
Muscle spasticity  1  16/107 (14.95%)  21 23/101 (22.77%)  38
Optic neuritis  1  6/107 (5.61%)  6 5/101 (4.95%)  8
Paraesthesia  1  33/107 (30.84%)  66 32/101 (31.68%)  75
Peroneal nerve palsy  1  0/107 (0.00%)  0 7/101 (6.93%)  10
Sensory disturbance  1  6/107 (5.61%)  9 5/101 (4.95%)  8
Sinus headache  1  4/107 (3.74%)  5 7/101 (6.93%)  7
Tremor  1  16/107 (14.95%)  39 9/101 (8.91%)  33
Visual field defect  1  2/107 (1.87%)  2 6/101 (5.94%)  6
Psychiatric disorders     
Affect lability  1  6/107 (5.61%)  16 6/101 (5.94%)  10
Anxiety  1  30/107 (28.04%)  53 28/101 (27.72%)  65
Depression  1  33/107 (30.84%)  86 40/101 (39.60%)  118
Emotional distress  1  4/107 (3.74%)  13 8/101 (7.92%)  21
Insomnia  1  33/107 (30.84%)  90 36/101 (35.64%)  92
Stress  1  4/107 (3.74%)  5 6/101 (5.94%)  10
Renal and urinary disorders     
Dysuria  1  9/107 (8.41%)  13 7/101 (6.93%)  14
Micturition urgency  1  22/107 (20.56%)  41 31/101 (30.69%)  60
Pollakiuria  1  18/107 (16.82%)  35 26/101 (25.74%)  35
Urinary hesitation  1  8/107 (7.48%)  9 10/101 (9.90%)  15
Urinary incontinence  1  17/107 (15.89%)  38 12/101 (11.88%)  28
Urinary retention  1  7/107 (6.54%)  17 11/101 (10.89%)  16
Reproductive system and breast disorders     
Erectile dysfunction  1  4/107 (3.74%)  4 6/101 (5.94%)  16
Menorrhagia  1  6/107 (5.61%)  9 5/101 (4.95%)  5
Menstruation irregular  1  10/107 (9.35%)  30 7/101 (6.93%)  12
Metrorrhagia  1  6/107 (5.61%)  9 2/101 (1.98%)  4
Vaginal haemorrhage  1  4/107 (3.74%)  6 6/101 (5.94%)  10
Respiratory, thoracic and mediastinal disorders     
Cough  1  13/107 (12.15%)  25 12/101 (11.88%)  22
Dyspnoea  1  25/107 (23.36%)  68 11/101 (10.89%)  25
Nasal congestion  1  6/107 (5.61%)  6 9/101 (8.91%)  21
Oropharyngeal pain  1  22/107 (20.56%)  41 14/101 (13.86%)  26
Sinus congestion  1  7/107 (6.54%)  10 4/101 (3.96%)  6
Sleep apnoea syndrome  1  2/107 (1.87%)  2 7/101 (6.93%)  7
Skin and subcutaneous tissue disorders     
Acne  1  6/107 (5.61%)  9 7/101 (6.93%)  9
Alopecia  1  8/107 (7.48%)  13 4/101 (3.96%)  5
Dry skin  1  7/107 (6.54%)  10 1/101 (0.99%)  2
Erythema  1  16/107 (14.95%)  18 9/101 (8.91%)  12
Hyperhidrosis  1  6/107 (5.61%)  7 1/101 (0.99%)  1
Pruritus  1  7/107 (6.54%)  11 6/101 (5.94%)  14
Rash  1  17/107 (15.89%)  26 21/101 (20.79%)  34
Urticaria  1  7/107 (6.54%)  8 8/101 (7.92%)  14
Surgical and medical procedures     
Tooth extraction  1  7/107 (6.54%)  9 1/101 (0.99%)  1
Vascular disorders     
Flushing  1  22/107 (20.56%)  104 9/101 (8.91%)  67
Hot flush  1  4/107 (3.74%)  7 6/101 (5.94%)  12
Hypertension  1  11/107 (10.28%)  14 15/101 (14.85%)  20
1
Term from vocabulary, MedDRA v19.0
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.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 1-888-483-8279
EMail: USMedInfo@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products R&D, Inc. )
ClinicalTrials.gov Identifier: NCT00203021    
Other Study ID Numbers: GA-9004
01-9004 ( Other Identifier: Teva )
First Submitted: September 12, 2005
First Posted: September 20, 2005
Results First Submitted: June 24, 2019
Results First Posted: July 18, 2019
Last Update Posted: February 18, 2020