Trial Outcomes & Findings for Long Term Study of Avonex Therapy Following a First Attack of Multiple Sclerosis (NCT NCT00179478)

Last Updated: 2017-09-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

155 participants

Primary outcome timeframe

10 years

Results posted on

2017-09-06

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	81	74
Overall Study COMPLETED	68	59
Overall Study NOT COMPLETED	13	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate Treatment Group n=81 Participants 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 n=74 Participants 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 n=155 Participants Total of all reporting groups
Age, Continuous	35 years STANDARD_DEVIATION 7 • n=5 Participants	34 years STANDARD_DEVIATION 7 • n=7 Participants	34 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	53 Participants n=7 Participants	113 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	72 Participants n=5 Participants	69 Participants n=7 Participants	141 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Non White	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Family History of MS	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Brainstem/Cerebellar at onset	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Optic neuritis at onset	40 Participants n=5 Participants	38 Participants n=7 Participants	78 Participants n=5 Participants
Spinal cord syndrome at onset	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
EDSS < 2.0 at onset	47 Participants n=5 Participants	55 Participants n=7 Participants	102 Participants n=5 Participants
EDSS 2.0-2.5 at onset	24 Participants n=5 Participants	15 Participants n=7 Participants	39 Participants n=5 Participants
EDSS > 2.5 at onset	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Median T2 lesion # at onset	13 lesion counts n=5 Participants	13 lesion counts n=7 Participants	13 lesion counts n=5 Participants
Median T2 lesion vol at onset	2063 mm^3 n=5 Participants	1774 mm^3 n=7 Participants	1930 mm^3 n=5 Participants
Gad enhancing lesions at onset	26 Participants n=5 Participants	17 Participants n=7 Participants	43 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 years

Outcome measures

Outcome measures
Measure	Immediate Treatment Group n=81 Participants 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 n=74 Participants 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.
Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years	58 Percent cumulative probability Interval 48.0 to 68.0	69 Percent cumulative probability Interval 61.0 to 78.0

SECONDARY outcome

Timeframe: 10 years

Population: Analysis only in 10 year completers

annualized # of relapses between years 0 and 10

Outcome measures

Outcome measures
Measure	Immediate Treatment Group n=68 Participants 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 n=59 Participants 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.
Annualized Relapse Rate	0.16 annualized relapses per year Standard Deviation 0.18	0.33 annualized relapses per year Standard Deviation 0.41

SECONDARY outcome

Timeframe: 10 years

Population: Numbers of patients completing 10 year evaluations

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.

Outcome measures

Outcome measures
Measure	Immediate Treatment Group n=68 Participants 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 n=59 Participants 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.
Number of Participants With an EDSS > 3.5 at Study Completion	7 Participants	5 Participants

SECONDARY outcome

Timeframe: 10 years

Population: Analysis restricted to those participants with MRI scans able to evaluate at 10 years

These are counts of new or significantly enlarged lesions over 10 years on brain MRI reflecting interval radiographic disease activity

Outcome measures

Outcome measures
Measure	Immediate Treatment Group n=55 Participants 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 n=55 Participants 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.
The Number of New or Enlarging MRI T2 Lesions at 10 Years	5 # of new or enlarging T2 lesions Interval 1.0 to 12.0	7 # of new or enlarging T2 lesions Interval 3.0 to 17.0

Adverse Events

All Study Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Revere P Kinkel MD (PI)

University of California San Diego

Phone: 619-543-5295

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place