A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple Sclerosis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 260

Inclusion Criteria

- Male and female patients (age =18 to 60 years), with RRMS.
- At least 1 documented relapse within the previous year and presence of T1 or T2 graded brain lesions.
- Kurtzke EDSS score from 0 to 5 (inclusive) at Screening.
- At Screening, females of childbearing potential must be non-pregnant and non-lactating; or females should be of non-childbearing potential.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Manifestation of multiple sclerosis (MS) other than RRMS.
- Relapse within the 30 days prior Screening and until administration of the first dose of study drug.
- Prior treatment with natalizumab, alemtuzumab, ocrelizumab, daclizumab, rituximab, cladribine, or other B- and T-cell targeting therapies.
- Active infections requiring oral or parenteral antibiotic treatment within 2 weeks prior to Screening
- Increased risk of opportunistic infections; exclusion determination to be made after consultation with the Medical Monitor.
- Patients with high JCV index.
- Past or current PML diagnosis.
- Presence of malignancies or neoplastic diseases; past history of malignancies within 5 years prior to Screening (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved).
- History or known presence of recurrent or chronic infection other than recurring urinary tract infections (i.e., hepatitis A, B, or C, human
immunodeficiency virus [HIV], tuberculosis).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate and compare the cumulative number of new active lesions;Secondary Objective: Evaluate and compare<br>- new active lesions over time<br>- the annualized relapse rates and changes in EDSS <br>- local and systemic adverse events (AEs) and serious adverse events (SAEs)<br>- immunogenic profile<br>- natalizumab systemic concentration<br>- safety profile <br>;Primary end point(s): Cumulative number of new active lesions;Timepoint(s) of evaluation of this end point: The analysis will be conducted when all patients have completed the End-of-Study Visit (Visit 13, Week 48) or have discontinued.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - new active lesions over time<br>- the annualized relapse rates and changes in EDSS <br>- local and systemic adverse events (AEs) and serious adverse events (SAEs)<br>- immunogenic profile<br>- natalizumab systemic concentration<br>- safety profile <br>;Timepoint(s) of evaluation of this end point: over 24 and 48 weeks

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