Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02097849
• Date of registration: 25/03/2014
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.
• Scientific title: An Open-Label Study to Assess the Immune Response to Vaccination in Tecfidera® (BG00012)-Treated Versus Interferon-Treated Subjects With Relapsing Forms of Multiple Sclerosis.
• Date of first enrolment: February 28, 2015
• Target sample size: 71
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02097849
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Must have a confirmed diagnosis of relapsing remitting MS per the 2010 McDonald
criteria.

- Must have a known tetanus immunization history with most recent tetanus vaccination
given 2 to 15 years prior to Screening and an anti-tetanus serum immunoglobulin titer
at Screening that is less than or equal to one-half the upper limit of detection for
the assay.

- Must have been on a stable approved dose of Tecfidera (240 mg twice daily [BID])
[Group 1] for =6 months or on a stable approved dose of a non-pegylated IFN (e.g.,
Avonex, Betaseron, Rebif, Extavia) [Group 2] for =3 months prior to Day 1.

Key Exclusion Criteria:

- Clinical relapse requiring treatment within 30 days prior to Day 1.

- Pneumococcal vaccination within 5 years prior to Screening.

- Previous exposure to meningococcal vaccines.

- Known hypersensitivity to Td, PPSV23, or MCV4 or their components.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Forms of Multiple Sclerosis

Intervention(s)

Biological: 23-valent pneumococcal polysaccharide vaccine

Biological: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent)

Drug: dimethyl fumarate

Drug: non-pegylated interferon

Biological: tetanus diphtheria toxoids vaccine

Primary Outcome(s)

Percentage of Tetanus Responders (= 2-Fold Rise) at Day 28 Compared to Prevaccination Level [Time Frame: Up to Week 4 (Day 28) postvaccination]

Secondary Outcome(s)

Number of Participants With Abnormalities in Vital Signs [Time Frame: Screening to Week 4]

Ratio of Serum Tetanus Level at Day 28 to Prevaccination [Time Frame: Up to Week 4 (Day 28) postvaccination]

Percentage of Meningococcal Serogroup C Responders (= 2-Fold Rise) Compared to Prevaccination Level [Time Frame: Up to Week 4 (Day 28) postvaccination]

Percentage of Pneumococcal Serotype 3 (= 4-Fold Rise) Responders Compared to Prevaccination Level [Time Frame: Up to Week 4 (Day 28) postvaccination]

Percentage of Tetanus Responders (= 4-Fold Rise) at Day 28 Compared to Prevaccination Level [Time Frame: Up to Week 4 (Day 28) postvaccination]

Number of Participants With Shifts From Baseline in Hematology [Time Frame: Screening to Week 4]

Percentage of Pneumococcal Serotype 3 (= 2-Fold Rise) Responders Compared to Prevaccination Level [Time Frame: Up to Week 4 (Day 28) postvaccination]

Ratio of Serum Meningococcal Antibodies (Serogroup C) Level at Day 28 to Prevaccination [Time Frame: Up to Week 4 (Day 28) postvaccination]

Ratio of Serum Pneumococcal Antibodies (Serotype 3) Level at Day 28 to Prevaccination [Time Frame: Up to Week 4 (Day 28) postvaccination]

Percentage of Meningococcal Serogroup C Responders (= 4-Fold Rise) Compared to Prevaccination Level [Time Frame: Up to Week 4 (Day 28) postvaccination]

Percentage of Pneumococcal Serotype 8 (= 4-Fold Rise) Responders Compared to Prevaccination Level [Time Frame: Up to Week 4 (Day 28) postvaccination]

Ratio of Serum Pneumococcal Antibodies (Serotype 8) Level at Day 28 to Prevaccination [Time Frame: Up to Week 4 (Day 28) postvaccination]

Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs [Time Frame: Day 1 to Week 4]

Number of Participants With Shifts From Baseline in Blood Chemistry [Time Frame: Screening to Week 4]

Percentage of Pneumococcal Serotype 8 (= 2-Fold Rise) Responders Compared to Prevaccination Level [Time Frame: Up to Week 4 (Day 28) postvaccination]

Secondary ID(s)

109MS307

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/06/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02097849