Trial · NCT07189325
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relapse | From Day 0 to Month 36 | Presence of at least one clinical relapse defined as new or worsening symptoms related to MS resulting in objective signs on neurological examination in the absence of any potential trigger not related to MS. |
| Primary | New/enlarged MRI lesions | From Day 0 to Month 36 | New/enlarged T2/FLAIR lesion on MRI scans to assess MRI disease activity . |
| Secondary | Relapse | From Day 0 to Month 36 | Presence of at least one clinical relapse defined as new or worsening symptoms related to MS resulting in objective signs on neurological examination in the absence of any potential trigger not related to MS |
| Secondary | Expanded Disability Status Scale (EDSS) | From Day 0 to Month 36 | EDSS to compare disability between both groups. This score is expressed from 0 (no disability) to 10 (multiple sclerosis-related death) and incorporates evaluation of the following neurological systems (pyramidal, sensory, cerebellar, sphincter, cognitive, and cranial pairs) |
| Secondary | Brain MRI (T2/FLAIR Lesions) | From Day 0 to Month 36 | MRI scans to compare new/enlarged T2/FLAIR lesions between both groups. |
| Secondary | Number of adverse events and severe adverse events | From Day 0 to Month 36 | To compare adverse events and severe adverse events between both groups. |
| Secondary | Number of infections and serious infections | From Day 0 to Month 36 | To compare infections and serious infections between both groups. |
| Secondary | B-cell count (CD19/CD20 B cells) | From Day 0 to Month 36 | B-cell count (CD19/CD20 B cells) to compare C• B-cells repopulation (CD19/CD20+ B-cells) between both groups. |
| Secondary | Serum immunoglobulin (IgG, IgA, IgM) levels | From Day 0 to Month 36 | Serum immunoglobulin (IgG, IgA, IgM) levels to compare • Immunoglobulin (IgG, A, M) levels changes between both groups. |
| Other | Multiple Sclerosis Functional Composite (MSFC) | From Day 0 to Month 36 | MSFC including the 9-Hole Peg Test (9HPT), Timed 25 Foot Walk (T25FW), and Paced Auditory Serial Addition Test (PASAT) to compare functional disability between both groups. |
| Other | The Computerised Speed Cognitive Test (CSCT) | From Day 0 to Month 36 | CSCT a cognitive test to compare the detection of information speed disorders between both groups. |
| Other | Neurofilament Light Chains (sNfL) Serum Concentration | From Day 0 to Month 36 | Neurofilament Light Chains (sNfL) Serum Concentration to compare change of serum Neurofilament light chains bteween both groups. |
| Other | The 5 Level European Quality of Life 5 Dimensions (EQ5D-5L) | From Day 0 to Month 36 | EQ5D-5L questionnaire to compare the generic quality of life between both groups. |
| Other | MUSICARE | From Day 0 to Month 36 | MUSICARE, self-report questionnaire to compare the experience of both patients and caregivers of quality of care in MS between both groups. |
| Other | CD27+ memory B-cell count | From Day 0 to Month 36 | CD27+ memory B-cell count to compare CD27+ memory B-cells repopulation between both groups. |
| Other | Patient-level cost | From Day 0 to Month 36 | Healthcare consumption collected via data from the SNDS (French Health Insurance Database) to assess medico-economic impact. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07189325/registered