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Long Term Study of Avonex Therapy Following a First Attack of Multiple Sclerosis (CHAMPIONS10)

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ClinicalTrials.gov Identifier: NCT00179478
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : September 6, 2017
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
R. Philip Kinkel, Beth Israel Deaconess Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Multiple Sclerosis
Optic Neuritis
Transverse Myelitis
Acute Brainstem/Cerebellar Syndrome
Intervention Drug: interferon beta 1a 30 ug IM once weekly
Enrollment 155

Recruitment Details Participants in the CHAMPIONS 5 year extension study were offered participation in the 10 year extension if their study site participated in the 10 year extension. Study arms were already establish at the onset of CHAMPIONS 10 extension
Pre-assignment Details  
Arm/Group Title Immediate Treatment Group Delayed Treatment Group
Hide Arm/Group Description

Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals

interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.

Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation

interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.

Period Title: Overall Study
Started 81 74
Completed 68 59
Not Completed 13 15
Arm/Group Title Immediate Treatment Group Delayed Treatment Group Total
Hide Arm/Group Description

Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals

interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.

Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation

interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.

Total of all reporting groups
Overall Number of Baseline Participants 81 74 155
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 74 participants 155 participants
35  (7) 34  (7) 34  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 74 participants 155 participants
Female
60
  74.1%
53
  71.6%
113
  72.9%
Male
21
  25.9%
21
  28.4%
42
  27.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 81 participants 74 participants 155 participants
White
72
  88.9%
69
  93.2%
141
  91.0%
Non White
9
  11.1%
5
   6.8%
14
   9.0%
Family History of MS  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 74 participants 155 participants
12
  14.8%
7
   9.5%
19
  12.3%
Brainstem/Cerebellar at onset  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 74 participants 155 participants
21
  25.9%
19
  25.7%
40
  25.8%
Optic neuritis at onset  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 74 participants 155 participants
40
  49.4%
38
  51.4%
78
  50.3%
Spinal cord syndrome at onset  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 74 participants 155 participants
20
  24.7%
17
  23.0%
37
  23.9%
EDSS < 2.0 at onset   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 74 participants 155 participants
47
  58.0%
55
  74.3%
102
  65.8%
[1]
Measure Description: Expanded Disability Status Scale (EDSS) is an ordinal measure of Neurological disability in Multiple Sclerosis ranging from 0-10 (0.5 increments) where 0 is normal and 10 is death from MS
EDSS 2.0-2.5 at onset  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 74 participants 155 participants
24
  29.6%
15
  20.3%
39
  25.2%
EDSS > 2.5 at onset  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 74 participants 155 participants
10
  12.3%
4
   5.4%
14
   9.0%
Median T2 lesion # at onset  
Median (Inter-Quartile Range)
Unit of measure:  Lesion counts
Number Analyzed 81 participants 74 participants 155 participants
13
(8 to 22)
13
(9 to 20)
13
(8 to 21)
Median T2 lesion vol at onset  
Median (Inter-Quartile Range)
Unit of measure:  Mm^3
Number Analyzed 81 participants 74 participants 155 participants
2063
(1003 to 4945)
1774
(786 to 4883)
1930
(918 to 4945)
Gad enhancing lesions at onset  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 74 participants 155 participants
26
  32.1%
17
  23.0%
43
  27.7%
1.Primary Outcome
Title Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years
Hide Description Percent cumulative probability of developing CDMS over 10 years . CDMS was defined as the development of new visual or neurological symptoms discrete from the patients initial event with objective findings on examination.
Time Frame 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate Treatment Group Delayed Treatment Group
Hide Arm/Group Description:

Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals

interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.

Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation

interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.

Overall Number of Participants Analyzed 81 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent cumulative probability
58
(48 to 68)
69
(61 to 78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate Treatment Group, Delayed Treatment Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Based on adjusted Hazard Ratio (HR)
Method Regression, Cox
Comments HR adjusted for age, onset event type, baseline brain MRI T2 lesion and number and baseline number of gad enhancing lesions
2.Secondary Outcome
Title Annualized Relapse Rate
Hide Description annualized # of relapses between years 0 and 10
Time Frame 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis only in 10 year completers
Arm/Group Title Immediate Treatment Group Delayed Treatment Group
Hide Arm/Group Description:

Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals

interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.

Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation

interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.

Overall Number of Participants Analyzed 68 59
Mean (Standard Deviation)
Unit of Measure: annualized relapses per year
0.16  (0.18) 0.33  (0.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate Treatment Group, Delayed Treatment Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments a priori threshold for statistical significance was a p value less than 0.01
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With an EDSS > 3.5 at Study Completion
Hide Description The EDSS is an ordinal scale of neurological impairment in Multiple Sclerosis with a range of 0 to 10 with 0.5 increments. A score of 0 is normal and 10 is death from MS. Scores from 1 to 3.5 are considered mild impairment , 4.0 to 6.5 is moderate and greater than 6.5 is severe impairment.
Time Frame 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Numbers of patients completing 10 year evaluations
Arm/Group Title Immediate Treatment Group Delayed Treatment Group
Hide Arm/Group Description:

Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals

interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.

Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation

interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.

Overall Number of Participants Analyzed 68 59
Measure Type: Count of Participants
Unit of Measure: Participants
7
  10.3%
5
   8.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate Treatment Group, Delayed Treatment Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments a priori threshold for statistical significance was a p value < 0.01
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title The Number of New or Enlarging MRI T2 Lesions at 10 Years
Hide Description These are counts of new or significantly enlarged lesions over 10 years on brain MRI reflecting interval radiographic disease activity
Time Frame 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis restricted to those participants with MRI scans able to evaluate at 10 years
Arm/Group Title Immediate Treatment Group Delayed Treatment Group
Hide Arm/Group Description:

Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals

interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.

Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation

interferon beta 1a 30 ug IM once weekly: Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.

Overall Number of Participants Analyzed 55 55
Median (Inter-Quartile Range)
Unit of Measure: # of new or enlarging T2 lesions
5
(1 to 12)
7
(3 to 17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate Treatment Group, Delayed Treatment Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments a priori threshold for statistical significant was a p value less than 0.01
Method Fisher Exact
Comments [Not Specified]
Time Frame Non serious and serious adverse events were not recorded during this extension study. For this study (n=155) only information on mortality was collected and categorized.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Study Participants
Hide Arm/Group Description All patients in the study were receiving the same FDA approved treatment, interferon beta 1a IM once weekly (AVONEX), which they received commercially through their insurance coverage. No AEs were collected and any serious AEs that occurred, would have been reported to the manufacturer (Biogen). We collected information on all cause mortality on the cohort of 155 patients who continued in the 10 year extension study. This was done as an additional outcome measure since we anticipated that there may be deaths due to the primary disease (MS) over a period of observation as long as 10 years.
All-Cause Mortality
All Study Participants
Affected / at Risk (%)
Total   2/155 (1.29%) 
Show Serious Adverse Events Hide Serious Adverse Events
All Study Participants
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Study Participants
Affected / at Risk (%)
Total   0/0 
selective attrition of patients with greater levels of disease activity may have occurred in this long term extension study
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Revere P Kinkel MD (PI)
Organization: University of California San Diego
Phone: 619-543-5295
Publications:
Responsible Party: R. Philip Kinkel, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00179478     History of Changes
Other Study ID Numbers: 2003P000086
C-850 Extension study ( Other Identifier: Biogen Inc )
First Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: April 14, 2017
Results First Posted: September 6, 2017
Last Update Posted: September 6, 2017