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| ID | Type | Description | Link |
|---|---|---|---|
| C-850 Extension study | Other Identifier | Biogen Inc |
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| Name | Class |
|---|---|
| Biogen | INDUSTRY |
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The current study is a continuation of the 5 year extension study of the phase III CHAMPS study (see reference). This study was designed to determine if immediate initiation of therapy with Interferon Beta-1a (AVONEX) after a first attack of multiple sclerosis (MS) continues to delay the development of further attacks (CDMS) and the development of neurological disability over a 10 year period of observation. The initial 5 year extension study, called CHAMPIONS5, reported that immediate initiation of interferon Beta-1a (AVONEX) after a first attack of MS continued to delay the development of CDMS and lowered relapse rates compared to delayed initiation of disease modifying treatment (usually with AVONEX) either at the time of a second attack or at the end of the phase III study (24 months). The study was extended to 10 years to determine if these effects are sustained and result in less long term permanent disability.
The CHAMPS study determined that immediate initiation of interferon beta 1a therapy (AVONEX) immediately following a first clinical demyelinating event in high risk patients (i.e. those with at least 2 asymptomatic white matter lesions on cranial MR imaging > 3 mm in diameter or ovoid) delayed the development of clinical definite Multiple Sclerosis (CDMS)(as defined by a second, clinically verifiable attack involving another part of the central nervous system) over 2 years of observation and significantly decreased the development of new or enlarging white matter lesions on MRI over 18 months (see reference). The current study is a long term extension of a cohort of CHAMPS study site and participants. The three main aims of the study are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Treatment Group | Experimental | Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals |
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| Delayed Treatment Group | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interferon beta 1a 30 ug IM once weekly | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years | 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. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate | annualized # of relapses between years 0 and 10 | 10 years |
| Number of Participants With an EDSS > 3.5 at Study Completion | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Revere P Kinkel, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MS Treatment Center at Griffin Hospital | Derby | Connecticut | 06418 | United States | ||
| Jaeb Center for Health Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11006365 | Background | Jacobs LD, Beck RW, Simon JH, Kinkel RP, Brownscheidle CM, Murray TJ, Simonian NA, Slasor PJ, Sandrock AW. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group. N Engl J Med. 2000 Sep 28;343(13):898-904. doi: 10.1056/NEJM200009283431301. | |
| 16436649 | Background |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Open label study: The outcome committee determined the primary outcome event (the development of Clinically definite MS) without knowledge of original treatment assignment and the central MRI reading center was not aware of original treatment assignments
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| 10 years |
| The Number of New or Enlarging MRI T2 Lesions at 10 Years | These are counts of new or significantly enlarged lesions over 10 years on brain MRI reflecting interval radiographic disease activity | 10 years |
| Tampa |
| Florida |
| 33647 |
| United States |
| MS Center of Atlanta | Atlanta | Georgia | 30327 | United States |
| Beta Research, Inc | Elk Grove | Illinois | 60007 | United States |
| University of Iowa College of Medicine | Iowa City | Iowa | 52242 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| St. Louis University Health Sciences Center | St Louis | Missouri | 63110 | United States |
| Jacobs Neurological Institute | Buffalo | New York | 14203 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Carolinas Medical Center - MS Center | Charlotte | North Carolina | 28207 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| The Neurology Group | Norristown | Pennsylvania | 19401 | United States |
| Univeristy of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny Neurological Associates | Pittsburgh | Pennsylvania | 15212 | United States |
| Univeristy of Texas Houston Health Science Center | Houston | Texas | 77030 | United States |
| Virginia Commonwealth University/Medical College of Virginia | Richmond | Virginia | 23219 | United States |
| Neurological Associates, Inc. | Richmond | Virginia | 23230 | United States |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | United States |
| Vancouver Hospital Health Sciences Centre | Vancouver | British Columbia | V6T 2B5 | Canada |
| QEII Health Sciences Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Ottawa General Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| University of Toronto - St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Hospital Notre Dame | Montreal | Quebec | H2l 4M1 | Canada |
| Montreal Neurological Institute | Montreal | Quebec | H3A 2B4 | Canada |
| Kinkel RP, Kollman C, O'Connor P, Murray TJ, Simon J, Arnold D, Bakshi R, Weinstock-Gutman B, Brod S, Cooper J, Duquette P, Eggenberger E, Felton W, Fox R, Freedman M, Galetta S, Goodman A, Guarnaccia J, Hashimoto S, Horowitz S, Javerbaum J, Kasper L, Kaufman M, Kerson L, Mass M, Rammohan K, Reiss M, Rolak L, Rose J, Scott T, Selhorst J, Shin R, Smith C, Stuart W, Thurston S, Wall M; CHAMPIONS Study Group. IM interferon beta-1a delays definite multiple sclerosis 5 years after a first demyelinating event. Neurology. 2006 Mar 14;66(5):678-84. doi: 10.1212/01.wnl.0000200778.65597.ae. Epub 2006 Jan 25. |
| 21987393 | Background | Kinkel RP, Dontchev M, Kollman C, Skaramagas TT, O'Connor PW, Simon JH; Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance Investigators. Association between immediate initiation of intramuscular interferon beta-1a at the time of a clinically isolated syndrome and long-term outcomes: a 10-year follow-up of the Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance. Arch Neurol. 2012 Feb;69(2):183-90. doi: 10.1001/archneurol.2011.1426. Epub 2011 Oct 10. |
| 25344370 | Background | Simon JH, Kinkel RP, Kollman C, O'Connor P, Fisher E, You X, Hyde R; CHAMPIONS Investigators Group. Ten-year follow-up of the 'minimal MRI lesion' subgroup from the original CHAMPS Multiple Sclerosis Prevention Trial. Mult Scler. 2015 Apr;21(4):415-22. doi: 10.1177/1352458514547407. Epub 2014 Oct 24. |
| 25741224 | Background | Kinkel RP, Laforet G, You X. Disease-related determinants of quality of life 10 years after clinically isolated syndrome. Int J MS Care. 2015 Jan-Feb;17(1):26-34. doi: 10.7224/1537-2073.2013-041. |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Family History of MS | Count of Participants | Participants |
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| Brainstem/Cerebellar at onset | Count of Participants | Participants |
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| Optic neuritis at onset | Count of Participants | Participants |
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| Spinal cord syndrome at onset | Count of Participants | Participants |
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| EDSS < 2.0 at onset | 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 | Count of Participants | Participants |
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| EDSS 2.0-2.5 at onset | Count of Participants | Participants |
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| EDSS > 2.5 at onset | Count of Participants | Participants |
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| Median T2 lesion # at onset | Median | Inter-Quartile Range | lesion counts |
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| Median T2 lesion vol at onset | Median | Inter-Quartile Range | mm^3 |
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| Gad enhancing lesions at onset | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years | 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. | Posted | Number | 95% Confidence Interval | Percent cumulative probability | 10 years |
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| Secondary | Annualized Relapse Rate | annualized # of relapses between years 0 and 10 | Analysis only in 10 year completers | Posted | Mean | Standard Deviation | annualized relapses per year | 10 years |
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| Secondary | Number of Participants With an EDSS > 3.5 at Study Completion | 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. | Numbers of patients completing 10 year evaluations | Posted | Count of Participants | Participants | 10 years |
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| Secondary | The Number of New or Enlarging MRI T2 Lesions at 10 Years | These are counts of new or significantly enlarged lesions over 10 years on brain MRI reflecting interval radiographic disease activity | Analysis restricted to those participants with MRI scans able to evaluate at 10 years | Posted | Median | Inter-Quartile Range | # of new or enlarging T2 lesions | 10 years |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Study Participants | 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. | 2 | 155 | 0 | 0 | 0 | 0 |
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selective attrition of patients with greater levels of disease activity may have occurred in this long term extension study
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Revere P Kinkel MD (PI) | University of California San Diego | 619-543-5295 | rkinkel@ucsd.edu |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009902 | Optic Neuritis |
| D009188 | Myelitis, Transverse |
| D002526 | Cerebellar Diseases |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D002493 | Central Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D019636 | Neurodegenerative Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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| Male |
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| Non White |
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