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Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis (SURPASS)

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ClinicalTrials.gov Identifier: NCT01058005
Recruitment Status : Terminated (Due to significantly slower than expected enrollment, the Sponsor decided to terminate the study.)
First Posted : January 28, 2010
Results First Posted : August 13, 2014
Last Update Posted : September 3, 2014
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Relapsing Remitting Multiple Sclerosis
Interventions Drug: BG00002 (natalizumab)
Drug: interferon beta-1a
Drug: glatiramer acetate
Enrollment 84
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Natalizumab Interferon Beta-1a Glatiramer Acetate
Hide Arm/Group Description 300 mg intravenous injection every 4 weeks 44 mcg subcutaneous injection 3 times per week 20 mg subcutaneous injection once daily
Period Title: Overall Study
Started 38 25 21
Dosed With Study Treatment 36 22 17
Completed 0 0 1
Not Completed 38 25 20
Reason Not Completed
Adverse Event             0             2             1
Physician Decision             2             2             0
Withdrawal by Subject             4             5             11
Withdrawn Due to Study Termination             27             13             7
Reason Missing             5             3             1
Arm/Group Title Natalizumab Interferon Beta-1a Glatiramer Acetate Total
Hide Arm/Group Description 300 mg intravenous injection every 4 weeks 44 mcg subcutaneous injection 3 times per week 20 mg subcutaneous injection once daily Total of all reporting groups
Overall Number of Baseline Participants 36 22 17 75
Hide Baseline Analysis Population Description
Participants who received at least 1 dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 22 participants 17 participants 75 participants
35.8  (9.51) 39.0  (10.0) 37.6  (13.16) 37.1  (10.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 22 participants 17 participants 75 participants
Female
30
  83.3%
16
  72.7%
13
  76.5%
59
  78.7%
Male
6
  16.7%
6
  27.3%
4
  23.5%
16
  21.3%
1.Primary Outcome
Title Incidence of Treatment-emergent Serious Adverse Events (SAEs)
Hide Description An SAE was defined as any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event; however, this does not include an event that, had it occurred in a more severe form, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also have been any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definition above. See Adverse Events section below for further details.
Time Frame up to 108 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study medication.
Arm/Group Title Natalizumab Interferon Beta-1a Glatiramer Acetate
Hide Arm/Group Description:
300 mg intravenous injection every 4 weeks
44 mcg subcutaneous injection 3 times per week
20 mg subcutaneous injection once daily
Overall Number of Participants Analyzed 36 22 17
Measure Type: Number
Unit of Measure: participants
1 1 0
Time Frame Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Natalizumab Interferon Beta-1a Glatiramer Acetate
Hide Arm/Group Description 300 mg intravenous injection every 4 weeks 44 mcg subcutaneous injection 3 times per week 20 mg subcutaneous injection once daily
All-Cause Mortality
Natalizumab Interferon Beta-1a Glatiramer Acetate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Natalizumab Interferon Beta-1a Glatiramer Acetate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/36 (2.78%)   1/22 (4.55%)   0/17 (0.00%) 
Infections and infestations       
Meningitis Herpes  1  0/36 (0.00%)  1/22 (4.55%)  0/17 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Thyroid Cancer  1  1/36 (2.78%)  0/22 (0.00%)  0/17 (0.00%) 
Nervous system disorders       
Cerebral Venous Thrombosis  1  0/36 (0.00%)  1/22 (4.55%)  0/17 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Natalizumab Interferon Beta-1a Glatiramer Acetate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/36 (52.78%)   12/22 (54.55%)   11/17 (64.71%) 
Blood and lymphatic system disorders       
Lymphadenopathy  1  1/36 (2.78%)  0/22 (0.00%)  1/17 (5.88%) 
Anaemia Macrocytic  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Ear and labyrinth disorders       
Vertigo  1  1/36 (2.78%)  2/22 (9.09%)  1/17 (5.88%) 
Eye disorders       
Vision Blurred  1  1/36 (2.78%)  0/22 (0.00%)  1/17 (5.88%) 
Vitreous Floaters  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Gastrointestinal disorders       
Nausea  1  6/36 (16.67%)  2/22 (9.09%)  1/17 (5.88%) 
Vomiting  1  3/36 (8.33%)  3/22 (13.64%)  0/17 (0.00%) 
Constipation  1  0/36 (0.00%)  0/22 (0.00%)  2/17 (11.76%) 
Diarrhoea  1  0/36 (0.00%)  1/22 (4.55%)  1/17 (5.88%) 
Dysphagia  1  0/36 (0.00%)  1/22 (4.55%)  1/17 (5.88%) 
Gastrointestinal Disorder  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Periodontal Disease  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
General disorders       
Fatigue  1  4/36 (11.11%)  2/22 (9.09%)  3/17 (17.65%) 
Gait Disturbance  1  0/36 (0.00%)  2/22 (9.09%)  1/17 (5.88%) 
Pyrexia  1  2/36 (5.56%)  1/22 (4.55%)  0/17 (0.00%) 
Injection Site Reaction  1  0/36 (0.00%)  0/22 (0.00%)  2/17 (11.76%) 
Influenza Like Illness  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Injection Site Mass  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Injection Site Pruritus  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Injection Site Swelling  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Infections and infestations       
Urinary Tract Infection  1  5/36 (13.89%)  0/22 (0.00%)  0/17 (0.00%) 
Bronchitis  1  2/36 (5.56%)  1/22 (4.55%)  1/17 (5.88%) 
Nasopharyngitis  1  3/36 (8.33%)  1/22 (4.55%)  0/17 (0.00%) 
Sinusitis  1  3/36 (8.33%)  0/22 (0.00%)  1/17 (5.88%) 
Upper Respiratory Tract Infection  1  2/36 (5.56%)  1/22 (4.55%)  0/17 (0.00%) 
Vulvovaginal Mycotic Infection  1  1/36 (2.78%)  0/22 (0.00%)  1/17 (5.88%) 
Cystitis  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Gastritis Viral  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Gastroenteritis  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Herpes Zoster  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Hordeolum  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Influenza  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Tooth Infection  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Injury, poisoning and procedural complications       
Fall  1  0/36 (0.00%)  2/22 (9.09%)  1/17 (5.88%) 
Contusion  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Exposure To Toxic Agent  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Tibia Fracture  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Investigations       
Heart Rate Increased  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Vitamin D Decreased  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Metabolism and nutrition disorders       
Fluid Retention  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Vitamin B12 Deficiency  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Musculoskeletal and connective tissue disorders       
Pain In Extremity  1  1/36 (2.78%)  1/22 (4.55%)  2/17 (11.76%) 
Myalgia  1  1/36 (2.78%)  2/22 (9.09%)  0/17 (0.00%) 
Muscle Spasms  1  0/36 (0.00%)  0/22 (0.00%)  2/17 (11.76%) 
Muscle Fatigue  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Uterine Leiomyoma  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Nervous system disorders       
Multiple Sclerosis Relapse  1  1/36 (2.78%)  3/22 (13.64%)  5/17 (29.41%) 
Headache  1  5/36 (13.89%)  2/22 (9.09%)  1/17 (5.88%) 
Paraesthesia  1  3/36 (8.33%)  3/22 (13.64%)  1/17 (5.88%) 
Hypoaesthesia  1  1/36 (2.78%)  3/22 (13.64%)  0/17 (0.00%) 
Migraine  1  2/36 (5.56%)  1/22 (4.55%)  1/17 (5.88%) 
Dizziness  1  2/36 (5.56%)  1/22 (4.55%)  0/17 (0.00%) 
Loss Of Proprioception  1  0/36 (0.00%)  0/22 (0.00%)  2/17 (11.76%) 
Neuralgia  1  2/36 (5.56%)  0/22 (0.00%)  0/17 (0.00%) 
Hyperaesthesia  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Hypertonia  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Memory Impairment  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Orthostatic Tremor  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Psychiatric disorders       
Anxiety  1  0/36 (0.00%)  2/22 (9.09%)  1/17 (5.88%) 
Insomnia  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Stress  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Renal and urinary disorders       
Urinary Incontinence  1  1/36 (2.78%)  0/22 (0.00%)  1/17 (5.88%) 
Micturition Urgency  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  2/36 (5.56%)  0/22 (0.00%)  0/17 (0.00%) 
Oropharyngeal Pain  1  2/36 (5.56%)  0/22 (0.00%)  0/17 (0.00%) 
Epistaxis  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Upper Respiratory Tract Congestion  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  2/36 (5.56%)  0/22 (0.00%)  0/17 (0.00%) 
Dermatitis Contact  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Pruritus  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Subcutaneous Nodule  1  0/36 (0.00%)  0/22 (0.00%)  1/17 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Due to early termination of the study and the small size of the study population, there was insufficient power for efficacy and safety analyses. Only serious adverse events were to be captured and reported under the protocol.
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.
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Results Point of Contact
Name/Title: Biogen Idec Study Medical Director
Organization: Biogen Idec
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01058005     History of Changes
Other Study ID Numbers: 101MS325
First Submitted: January 26, 2010
First Posted: January 28, 2010
Results First Submitted: July 23, 2014
Results First Posted: August 13, 2014
Last Update Posted: September 3, 2014