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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Immediate Treatment Group

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 Treatment Group

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.


Participant Flow:   Overall Study
    Immediate Treatment Group   Delayed Treatment Group
STARTED   81   74 
COMPLETED   68   59 
NOT COMPLETED   13   15 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Immediate Treatment Group

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 Treatment Group

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 Total of all reporting groups

Baseline Measures
   Immediate Treatment Group   Delayed Treatment Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 81   74   155 
Age 
[Units: Years]
Mean (Standard Deviation)
 35  (7)   34  (7)   34  (7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      60  74.1%      53  71.6%      113  72.9% 
Male      21  25.9%      21  28.4%      42  27.1% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race/Ethnicity       
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 
[Units: Participants]
Count of Participants
 12   7   19 
Brainstem/Cerebellar at onset 
[Units: Participants]
Count of Participants
 21   19   40 
Optic neuritis at onset 
[Units: Participants]
Count of Participants
 40   38   78 
Spinal cord syndrome at onset 
[Units: Participants]
Count of Participants
 20   17   37 
EDSS < 2.0 at onset [1] 
[Units: Participants]
Count of Participants
 47   55   102 
[1] 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 
[Units: Participants]
Count of Participants
 24   15   39 
EDSS > 2.5 at onset 
[Units: Participants]
Count of Participants
 10   4   14 
Median T2 lesion # at onset 
[Units: Lesion counts]
Median (Inter-Quartile Range)
 13 
 (8 to 22) 
 13 
 (9 to 20) 
 13 
 (8 to 21) 
Median T2 lesion vol at onset 
[Units: Mm^3]
Median (Inter-Quartile Range)
 2063 
 (1003 to 4945) 
 1774 
 (786 to 4883) 
 1930 
 (918 to 4945) 
Gad enhancing lesions at onset 
[Units: Participants]
Count of Participants
 26   17   43 


  Outcome Measures

1.  Primary:   Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years   [ Time Frame: 10 years ]

2.  Secondary:   Annualized Relapse Rate   [ Time Frame: 10 years ]

3.  Secondary:   Number of Participants With an EDSS > 3.5 at Study Completion   [ Time Frame: 10 years ]

4.  Secondary:   The Number of New or Enlarging MRI T2 Lesions at 10 Years   [ Time Frame: 10 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
selective attrition of patients with greater levels of disease activity may have occurred in this long term extension study


  More Information

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
e-mail: rkinkel@ucsd.edu


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