Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Code: PB006
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Current Sponsor code: PB006
Concentration unit: mg/ml milligram(
Sponsors
Polpharma Biologics S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate and compare the cumulative number of new active lesions;Secondary Objective: Evaluate and compare - new active lesions over time - the annualized relapse rates and changes in EDSS - local and systemic adverse events (AEs) and serious adverse events (SAEs) - immunogenic profile - natalizumab systemic concentration - safety profile ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - new active lesions over time - the annualized relapse rates and changes in EDSS - local and systemic adverse events (AEs) and serious adverse events (SAEs) - immunogenic profile - natalizumab systemic concentration - safety profile ;Timepoint(s) of evaluation of this end point: over 24 and 48 weeks | — |
Countries
Belarus, Croatia, Georgia, Moldova, Republic of, Poland, Serbia, Ukraine
Contacts
Public ContactDirector of Clinical R&D
Polpharma Biologics S.A./ Karsten Roth
Outcome results
None listed