Trial · NCT05385744
An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis
NCT05385744, Phase 3, Completed, Biocad
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis. Trials, record NCT05385744. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05385744
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis
- NCT number
- NCT05385744
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 336 participants, actual
- Lead sponsor
- Biocad
- Conditions
- Multiple Sclerosis
- Interventions
- BCD-132, Teriflunomide
- First posted
- 2022-05-23
- Last updated
- 2024-11-25
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized relapse rate | week 48 | Annualized relapse rate at 48 weeks after the randomization of the last patient in the study |
| Secondary | Proportion of patients with persistent progression | week 48 | Persistent progression is defined as an increase in the EDSS score from Visit 1 by at least 1.0 in patients with a score \>0 and ≤5.5 at the first visit and by at least 1.5 in patients with a score of 0 at the first visit |
| Secondary | Total number of T1 Gd+ lesions | week 48 | Total number of T1 Gd+ lesions (per scan) detected on brain MRI; |
| Secondary | CUA | week 48 | Combined unique active lesions |
| Secondary | Proportion of patients without contrast-enhancing lesions | week 48 | Proportion of patients without contrast-enhancing lesions |
| Secondary | Number of new or enlarged T2 lesions | week 48 | Number of new or enlarged T2 lesions |
| Secondary | Proportion of patients without new or enlarged T2 lesions | week 48 | Proportion of patients without new or enlarged T2 lesions |
| Secondary | Changes in the neurologic deficit according to EDSS score | week 48 | Changes in the neurologic deficit according to Expanded Disability Status Scale |
| Secondary | Annualized relapse rate | week 48 | Mean annualized relapse rate |
| Secondary | Proportion of patients with adverse reactions | week 48 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05385744
GET https://conductscience.org/api/trials/v1/NCT05385744/registered