Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis
Source: ClinicalTrials.gov NCT03046251 ↗No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relapses Post Partum |
2; 7 | — |
| SECONDARY Expanded Disability Status Scale (EDSS) Worsening |
0; 4 | — |
| SECONDARY Difference in Mean Expanded Disability Status Scale (EDSS) Scores Between Persons With MS (pwMS) Treated With Natalizumab Versus Other Disease-modifying Therapies (DMT) |
1.8; 1.8 | — |
| SECONDARY Change in MRI |
3; 5; 1; 3 | — |
| SECONDARY Percent of Relapse Free Patients |
2; 17 | — |
Eligibility Criteria
Inclusion Criteria
- Female subjects postpartum, 0-30 days postpartum at the time of informed consent.
- Diagnosis of relapsing form of MS.
- Willing to initiating natalizumab and enroll in the TOUCH system.
- Willing and able to comply with the study procedures for the duration of the trial.
- Signed informed consent and HIPAA authorization.
Exclusion Criteria
- Diagnosis of primary progressive MS.
- Breastfeeding
- Use of IVIG in Tysabri treated subjects.
- Significant renal or hepatic impairment (in the opinion of the investigator) or other significant disease (e.g., cognitive impairment) that would compromise adherence and completion of the trial.
- History of hypersensitivity to previous exposure or presence of antibodies to natalizumab.
- Any other factor that, in the opinion of the investigator, would make the subject unsuitable for participation in this study.
- Patients that experience relapses and/or initiated DMT's during pregnancy
The Control group will consist of relapsing MS patients post-delivery who decline natalizumab therapy but open to enroll in the study.
Similar Inclusion and Exclusion criteria as the natalizumab group with the exception of requiring TOUCH enrollment program. The Control group will be allowed to initiate any FDA approved DMT at any time post delivery or remain on no therapy while breastfeeding.
Data sourced from ClinicalTrials.gov (NCT03046251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.