Contributions
Abstract: EP1781
Type: ePoster
Abstract Category: Therapy - disease modifying - 31 Treatment of progressive MS
Background: During the past two decades, many trials have been undertaken in order to improve our knowledge regarding the underlying mechanism and treatment of chronic progressive multiple sclerosis (CPMS). The latter is an old term which refers to advanced MS and includes both secondary progressive (SPMS) and primary progressive MS (PPMS). A lot of progress has been made in the understanding the pathogenesis and treatment of CPMS.
Objective: To review the criteria used by both investigator-led and pharmaceutical sponsored studies to recruit patients for chronic progressive MS trials. The objective of this review is to provide a summary of the different inclusion criteria which need to be fulfilled in order to be screened and recruited into a clinical trial investigating disease modifying therapies in CPMS.
Methods: Analysis of chronic progressive MS trials using a theclinicaltrial.gov website, Medline, EU clinical trials (EudraCT), Cochrane Central Register of Controlled Trials (CENTRAL) and ISRCTN register.
Results: 97 studies were included. Among them 17 showed positive results. Regarding subject selection, the age range is mainly between 18 and 65 years and very few studies include patients with an expanded disability status scale (EDSS) greater than 6.5. An important design feature of the majority of trials was the requirement of evidence of recent disease progression to be eligible for the study. This evidence can take several forms, ranging from clinical history, EDSS worsening over a certain period of time, or reduction of a patient´s performance using specific assessment tools, for example the 9 Hole-Peg Test or Timed-25-Foot Walk.
Conclusions: The main criteria for inclusion in trials of progressive multiple sclerosis is evidence of recent disease progression. However, to the best of our knowledge there does not appear to be a standardized protocol to assess the evolution of a patient´s disease course for inclusion in to CPMS trials. To overcome this issue, we believe that multiple sclerosis self-monitoring tools should be developed in order to help better assess the patient´s disease and its evolution, and to assist investigators' in fulfilling the necessary inclusion criteria for clinical trials.
Disclosure:
Nicolas Dubuisson is an ECTRIMS fellow, which is unrelated to the contents of this publication.
Monica Marta has received honoraria and travel costs from Genzyme, AbbVie and Novartis, unrelated to the context of this publication.
Sharmilee Gnanapavan has received honoraria for advisory boards and presentations from Genzyme and Novartis and travel support from Genzyme, Novartis and Teva. SG has received grant funding from Genzyme, which is unrelated to the contents of this publication.
Benjamin Turner has received travel grants and consultant fees for attending advisory boards from Biogen-Idec, TEVA, Merck-Serono, Novartis and Genzyme.
David Baker is a founder and consultant to Canbex therapeutics and has received research funds from Canbex therapeutics, Sanofi-Genzyme, and Takeda in the past 3 years.
Gavin Giovannoni has received compensation for participating on Advisory Boards in relation to clinical trial design, trial steering committees and data and safety monitoring committees from Abbvie, Bayer-Schering Healthcare, Biogen-Idec, Eisai, Elan, Fiveprime, Genzyme, Genentech, GSK, GW Pharma, Ironwood, Merck-Serono, Novartis, Pfizer, Roche, Sanofi-Aventis, Synthon BV, Teva, UCB Pharma, and Vertex Pharmaceuticals.
Klaus Schmierer has received speaking honoraria from and/or served on advisory boards for Biogen, Merck-Serono, Merck Inc, Novartis, Roche, and Teva, support for attending international conferences by Genzyme and Novartis, and has been a PI on studies sponsored by Novartis, Roche, Teva and Medday. Through KS Queen Mary University of London received non-promotional educational grants from Novartis.
Alison Thomson received honoraria for presentations from Novartis and non-promotional educational grants from Genzyme, Novartis and Biogen, which are unrelated to the contents of this publication.
Abstract: EP1781
Type: ePoster
Abstract Category: Therapy - disease modifying - 31 Treatment of progressive MS
Background: During the past two decades, many trials have been undertaken in order to improve our knowledge regarding the underlying mechanism and treatment of chronic progressive multiple sclerosis (CPMS). The latter is an old term which refers to advanced MS and includes both secondary progressive (SPMS) and primary progressive MS (PPMS). A lot of progress has been made in the understanding the pathogenesis and treatment of CPMS.
Objective: To review the criteria used by both investigator-led and pharmaceutical sponsored studies to recruit patients for chronic progressive MS trials. The objective of this review is to provide a summary of the different inclusion criteria which need to be fulfilled in order to be screened and recruited into a clinical trial investigating disease modifying therapies in CPMS.
Methods: Analysis of chronic progressive MS trials using a theclinicaltrial.gov website, Medline, EU clinical trials (EudraCT), Cochrane Central Register of Controlled Trials (CENTRAL) and ISRCTN register.
Results: 97 studies were included. Among them 17 showed positive results. Regarding subject selection, the age range is mainly between 18 and 65 years and very few studies include patients with an expanded disability status scale (EDSS) greater than 6.5. An important design feature of the majority of trials was the requirement of evidence of recent disease progression to be eligible for the study. This evidence can take several forms, ranging from clinical history, EDSS worsening over a certain period of time, or reduction of a patient´s performance using specific assessment tools, for example the 9 Hole-Peg Test or Timed-25-Foot Walk.
Conclusions: The main criteria for inclusion in trials of progressive multiple sclerosis is evidence of recent disease progression. However, to the best of our knowledge there does not appear to be a standardized protocol to assess the evolution of a patient´s disease course for inclusion in to CPMS trials. To overcome this issue, we believe that multiple sclerosis self-monitoring tools should be developed in order to help better assess the patient´s disease and its evolution, and to assist investigators' in fulfilling the necessary inclusion criteria for clinical trials.
Disclosure:
Nicolas Dubuisson is an ECTRIMS fellow, which is unrelated to the contents of this publication.
Monica Marta has received honoraria and travel costs from Genzyme, AbbVie and Novartis, unrelated to the context of this publication.
Sharmilee Gnanapavan has received honoraria for advisory boards and presentations from Genzyme and Novartis and travel support from Genzyme, Novartis and Teva. SG has received grant funding from Genzyme, which is unrelated to the contents of this publication.
Benjamin Turner has received travel grants and consultant fees for attending advisory boards from Biogen-Idec, TEVA, Merck-Serono, Novartis and Genzyme.
David Baker is a founder and consultant to Canbex therapeutics and has received research funds from Canbex therapeutics, Sanofi-Genzyme, and Takeda in the past 3 years.
Gavin Giovannoni has received compensation for participating on Advisory Boards in relation to clinical trial design, trial steering committees and data and safety monitoring committees from Abbvie, Bayer-Schering Healthcare, Biogen-Idec, Eisai, Elan, Fiveprime, Genzyme, Genentech, GSK, GW Pharma, Ironwood, Merck-Serono, Novartis, Pfizer, Roche, Sanofi-Aventis, Synthon BV, Teva, UCB Pharma, and Vertex Pharmaceuticals.
Klaus Schmierer has received speaking honoraria from and/or served on advisory boards for Biogen, Merck-Serono, Merck Inc, Novartis, Roche, and Teva, support for attending international conferences by Genzyme and Novartis, and has been a PI on studies sponsored by Novartis, Roche, Teva and Medday. Through KS Queen Mary University of London received non-promotional educational grants from Novartis.
Alison Thomson received honoraria for presentations from Novartis and non-promotional educational grants from Genzyme, Novartis and Biogen, which are unrelated to the contents of this publication.