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Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis (NAPPREMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03046251
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Bianca Weinstock-Guttman, State University of New York at Buffalo

Tracking Information
First Submitted Date  ICMJE February 3, 2017
First Posted Date  ICMJE February 8, 2017
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE August 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2017)
Annualized Relapse Rate (ARR) [ Time Frame: 48 weeks ]
The primary endpoint is the annualized relapse rate (ARR) during 1 year post-delivery in patients treated with natalizumab. This will be compared to the ARR in the parallel control group.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2017)
  • Confirmed (12 week) EDSS change [ Time Frame: 48 weeks ]
    Confirmed (12 week) EDSS change of 1 point or more for a baseline EDSS > 1, or a confirmed increase of 1.5 points for an EDSS of 0-1, at Week 48 as compared to baseline between the 2 groups
  • AUC-EDSS changes [ Time Frame: 48 weeks ]
    AUC-EDSS changes from baseline to week 48 between the groups
  • Change in MRI [ Time Frame: 48 weeks ]
    Change in MRI: MRI at Week 48 for: new or enlarging T2, and T1 gadolinium-enhancing (GdE) lesions counts compared to the change in MRI control group
  • Time to first relapse [ Time Frame: 48 weeks ]
    Time to first relapse postpartum will be evaluated and compared between the 2 groups.
  • Percent of relapse free patients [ Time Frame: 48 weeks ]
    Percent of relapse free patients between the groups
  • Percent of patient that discontinued their DMT [ Time Frame: 48 weeks ]
    Percent of patient that discontinued their DMT initiated post-partum
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 3, 2017)
Change in QOL measures [ Time Frame: 48 weeks ]
Change in QOL measures that will include: SF12v2, FSMC and MSIS-29 v2 from baseline to week 24 and 48 as compared to the control group.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis
Official Title  ICMJE Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis
Brief Summary The purpose of this study is to evaluate if monthly natalizumab, initiated after delivery, is effective in preventing postpartum relapses.
Detailed Description

Postpartum patients with a diagnosis of multiple sclerosis (MS) will be given the opportunity to enroll in this study that will evaluate the efficacy of IV natalizumab to prevent postpartum relapses. Natalizumab, administered as 300mg IV q 4 weeks, will be initiated postpartum (0-30 days post-delivery).

Patients who decline natalizumab treatment postpartum will be given the opportunity to enroll in the study in the control group. The control group will have similar inclusion and exclusion criteria as well as scheduled visit and study procedures as the active natalizumab treatment group.

The primary objective of the trial is to assess the efficacy of IV administered natalizumab, monthly for 1 year, in preventing relapses during the postpartum period.

The secondary objectives of the trial are to assess the efficacy of natalizumab in decreasing the risk for disability progression during the postpartum period and to prevent the appearance of new and/or enlarging brain MRI lesions as measured by qualitative MRI analysis.

The tertiary objective is to assess the association of the clinical outcomes with subject evaluations including patient reported outcomes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Drug: Natalizumab
Study Arms  ICMJE
  • natalizumab
    Participants in this group are those who opt to receive treatment with natalizumab IV 300mg/day given q 4 weeks for 48 weeks.
    Intervention: Drug: Natalizumab
  • No Intervention: Control
    Participants in this group may initiate any FDA approved DMT at any time post delivery or remain on no therapy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 3, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female subjects postpartum, 0-30 days postpartum at the time of informed consent.
  2. Diagnosis of relapsing form of MS.
  3. Willing to initiating natalizumab and enroll in the TOUCH system.
  4. Willing and able to comply with the study procedures for the duration of the trial.
  5. Signed informed consent and HIPAA authorization.

Exclusion Criteria:

  1. Diagnosis of primary progressive MS.
  2. Breastfeeding
  3. Use of IVIG in Tysabri treated subjects.
  4. 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.
  5. History of hypersensitivity to previous exposure or presence of antibodies to natalizumab.
  6. Any other factor that, in the opinion of the investigator, would make the subject unsuitable for participation in this study.
  7. 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kara Patrick 716-829-5037 kpatrick@buffalo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03046251
Other Study ID Numbers  ICMJE US-TYS-14-10720
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bianca Weinstock-Guttman, State University of New York at Buffalo
Study Sponsor  ICMJE State University of New York at Buffalo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bianca Weinstock-Guttman, MD SUNY Buffalo
PRS Account State University of New York at Buffalo
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP