Discontinuing Disease-modifying Therapies in Stable Relapsing - Onset Multiple Sclerosis (DOT-MS). (DOT-MS)
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|ClinicalTrials.gov Identifier: NCT04260711|
Recruitment Status : Recruiting
First Posted : February 7, 2020
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Secondary Progressive||Drug: DMT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Safety and Cost-effectiveness of Discontinuing Disease-modifying Therapies in Stable Relapsing - Onset Multiple Sclerosis (DOT-MS): a Randomized Rater-blinded Multicenter Trial.|
|Actual Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||August 1, 2023|
|Estimated Study Completion Date :||January 1, 2024|
Experimental: Discontinuation of DMT
Discontinuation of first-line disease modifying therapy (any of the interferons, glatiramer acetate, dimethylfumarate, teriflunomide)
Discontinuation of patients' own disease modifying therapy (any of the interferons, glatiramer acetate, dimethylfumarate, teriflunomide)
No Intervention: Continuation of DMT
Continuation of first-line disease modifying therapy (any of the interferons, glatiramer acetate, dimethylfumarate, teriflunomide)
- Clinical relapses [ Time Frame: 2 years ]New clinically confirmed relapses (defined according to the definition most often used in MS phase-III trials: the onset of new or recurrent symptoms that last > 24 hours, that are accompanied by new objective abnormalities on a neurological examination and that are not explained by non-MS processes such as fever, infection, severe stress or drug toxicity).
- New lesions on MRI-brain [ Time Frame: 2 years ]New inflammatory disease activity on MRI (defined as 3 or more lesions on T2-weighted vimages or 2 or more gadolinium enhancing lesions on T1-weighted post-contrast MRI).
- EDSS (Expanded Disability Status Scale) [ Time Frame: 2 years ]This score indicates disability on a scale of 0 to 10. A higher score indicates more disability.
- 9-hole peg test [ Time Frame: 2 years ]9-hole peg test (9HPT): test on hand function, measured in seconds. A shorter time indicates a better hand function.
- Timed 25-Foot Walk [ Time Frame: 2 years ]Timed 25-foot walk (T25FW): walking test, measured in seconds. A shorter time indicates a better walking function.
- Symbol Digits Modalities Test [ Time Frame: 2 years ]Symbol Digits Modalities Test (SDMT): measures cognition. Scored with a number from 0 to 110, a higher score indicates better cognitive function.
- MRI-parameter: T1 post-contrast lesion number [ Time Frame: 2 years ]Number of lesions on T1 post-contrast MRI
- MRI-parameter: T2 post-contrast lesion number [ Time Frame: 2 years ]Number of lesions on T2-MRI
- Multiple Sclerosis Impact Scale (MSIS-29) [ Time Frame: 2 years ]Questionnaire on the impact of MS on day-to-day life
- Short Form health survey (SF-36) [ Time Frame: 2 years ]Questionnaire on general health
- Checklist Individual Strength (CIS20r) [ Time Frame: 2 years ]Questionnaire on fatigue
- Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: 2 years ]Questionnaire on treatment satisfaction
- EuroQol 5 dimensions questionnaire (EQ-5D-5L) [ Time Frame: 2 years ]Questionnaire on quality of life and costs
- Medical consumption questionnaire (iMCQ) [ Time Frame: 2 years ]Questionnaire on medical consumption
- Productivity costs questionnaire (iPCQ) [ Time Frame: 2 years ]Questionnaire on productivity
- Neurofilament light level in serum [ Time Frame: 2 years ]Neurofilament light levels in serum
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04260711
|Contact: Eline Coerver, MScemail@example.com|
|Contact: Eva Strijbis, firstname.lastname@example.org|
|Contact: Eline Coerver, MSc email@example.com|
|Principal Investigator:||J. Killestein, prof. dr.||Amsterdam UMC, location VUmc|