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NCT04178005 · ClinicalTrials.gov registry record · Phase 4
Cladribine Tablets After Treatment With Natalizumab (CLADRINA)
A Phase 4 study of Multiple Sclerosis, sponsored by University of Texas Southwestern Medical Center.
- Active
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT04178005: Active Phase 4 study of Multiple Sclerosis, sponsored by University of Texas Southwestern Medical Center.
NCT04178005 is a Phase 4 study of Multiple Sclerosis that is active but no longer recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 40 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04178005, a Phase 4 study of Multiple Sclerosis, is active but no longer recruiting, sponsored by University of Texas Southwestern Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to generate hypotheses regarding the safety, efficacy, and immunological impact of cladribine tablets after treatment with natalizumab in patients with relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (active SPMS).
Primary Outcome
The absolute and percent change from baseline will be presented for each time point for CD3+ T lymphocytes, CD19+ B lymphocytes, CD11c+ DC subsets, NfL levels in blood, with a two-sided 95% CI and p value. As these data are not expected to be normally distributed, the nonparametric Wilcoxon signed rank test will be used to compare each biomarker at baseline and during treatment. Spearman rank correlations will be used to examine the relationship between biomarkers and clinical/safety endpoints.
Conditions Studied
Interventions
- DRUG Cladribine
Study Locations (2)
Kansas
- College Park Family Care Center Physicians Group - Overland Park
Texas
- UT Southwestern Medical center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-02-19 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
What the registry record for NCT04178005 still lists
NCT04178005 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Cladribine is the first listed.
NCT04178005 reports a single indexed study location in Kansas, Texas.
Frequently Asked Questions
What is clinical trial NCT04178005 about?
NCT04178005 is a clinical study titled "Cladribine Tablets After Treatment With Natalizumab (CLADRINA)". The purpose of this study is to generate hypotheses regarding the safety, efficacy, and immunological impact of cladribine tablets after treatment with natalizumab in patients with relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (active SPMS).
What is the current status of trial NCT04178005?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2020-02-19. Estimated completion is 2026-12.
What conditions does trial NCT04178005 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT04178005?
The interventions under investigation include: Cladribine (DRUG).
Who is sponsoring clinical trial NCT04178005?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04178005 being conducted?
This trial has 2 study locations across Kansas, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04178005's enrollment target sits among peer trials
40 197th of 315 higher than 108 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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