Trial · NCT04472975
Prescription Drug Safety and Effectiveness in Multiple Sclerosis
NCT04472975, Completed, University of British Columbia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prescription Drug Safety and Effectiveness in Multiple Sclerosis. Trials, record NCT04472975. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04472975
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prescription Drug Safety and Effectiveness in Multiple Sclerosis
- NCT number
- NCT04472975
- Status
- Completed
- Enrollment
- 35,000 participants, actual
- Lead sponsor
- University of British Columbia
- Conditions
- Multiple Sclerosis
- Interventions
- Exposure to one or more disease-modifying drug(s)(DMDs) used to treat MS
- First posted
- 2020-07-16
- Last updated
- 2024-05-16
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Study 1: All-cause hospitalizations | As recurrent events from study entry to study end, up to 22 years. | The outcome (all-cause hospitalizations) will be derived from the comprehensive hospital data, excluding pregnancy-related events, in 5 Canadian provinces (British Columbia, Manitoba, Nova Scotia, Saskatchewan and Alberta). |
| Primary | Study 2: All-cause mortality | Measured using Cox proportional hazards models (time from study entry to death), up to 22 years. | The outcome (all-cause mortality) will be derived from the province-wide death data (e.g., Vital Statistics or the equivalent) in 5 Canadian provinces (British Columbia, Manitoba, Nova Scotia, Saskatchewan and Alberta). |
| Primary | Study 3: Change in disability (Expanded Disability Status Scale [EDSS]) over time | Assessed using mixed effects model from study entry to study end, up to 22 years. | The outcomes (change in EDSS) will be derived from the MS clinical data in 3 Canadian provinces (British Columbia, Manitoba and Nova Scotia). |
| Secondary | Study 1: Physician consultation rates (overall and by physician specialty) | Overall numbers of physician consultations will be measured from study entry to study end, up to 22 years of follow-up. | The outcome (physician consultation) will be derived from the physician data, excluding pregnancy-related events, in 5 Canadian provinces (British Columbia, Manitoba, Nova Scotia, Saskatchewan and Alberta). |
| Secondary | Study 3: MS disability, measured using the Expanded Disability Status Scale (EDSS) and assessed as time to sustained EDSS 6 | Measured using Cox proportional hazards models (time from study entry to sustained EDSS 6 confirmed after at least 6 months with no subsequent improvement), up to 22 years of follow-up. | The outcome (sustained EDSS 6) will be derived from the MS clinical data in 3 Canadian provinces (British Columbia, Manitoba and Nova Scotia). |
| Secondary | Study 3: Sustained EDSS 4 | Measured using Cox proportional hazards models (time from study entry to sustained EDSS 4), up to 22 years of follow-up. | The outcomes (sustained EDSS 4) will be derived from the MS clinical data in 3 Canadian provinces (British Columbia, Manitoba and Nova Scotia). |
| Secondary | Study 4: Explore the modifying effects | From study entry to study end, up to 22 years of follow-up. | Effects of sex, age, comorbidity and DMD treatment duration on outcomes (all-cause hospitalizations, physician consultation rates, all-cause mortality, changes in EDSS) will be assessed. |
| Secondary | Study 5: Potential incident adverse events | Time from study entry to the incident adverse event of interest will be assessed using Cox proportional hazards with time-varying DMD exposure, up to 22 years of follow-up. | 'Incident' event defined as not present in the year before DMD initiation. The outcomes (incident adverse events) will be identified using physician and hospital claims, coded using International Classification of Diseases \[ICD\]-9/10 and prescriptions filled (by ATC levels), in 5 Canadian provinces (British Columbia, Manitoba, Nova Scotia, Saskatchewan and Alberta). An additional, data mining, discovery approach will assess the associations between exposure and adverse events using unsupervised machine learning techniques. Cases of PML will be described. |
| Secondary | Study 6: Characteristics associated with risk of adverse events | From study entry to study end, up to 22 years of follow-up. | Examine demographic and clinical characteristics associated with risk of adverse events, including sex, age, comorbidity and DMD treatment duration. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34949130 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04472975
GET https://conductscience.org/api/trials/v1/NCT04472975/registered