Health Condition 1: null- Patients with relapsing forms of multiple sclerosis Diagnosis of RRMS according to McDonaldâ??s Criteria â?? revision 2010 (Polman et al., 2011)
Conditions
Interventions
Intervention1: recombinant human interferon beta-1b (rhIFN beta-1b) product: The active pharmaceutical ingredient (rhIFN beta-1b) in NU100 is chemically identical (i.e. the same amino acid sequence) t
Sponsors
Nuron Biotech Inc
Semler Research Center Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female or male patients, aged between 18 and 60 years, inclusive 2. Signed and dated statement of informed consent 3. Diagnosis of RRMS according to McDonaldâ??s Criteria â?? revision 2010 (Polman et al., 2011) 4. Interferon (IFN) beta-1b naïve 5. Expanded Disability Status Scale (EDSS) score of 6. At least 1 documented relapse in the past year (defined as the appearance of a new clinical sign/symptom [one that had been stable for at least 30 days] that persisted for a minimum of 24 hours in the absence of fever) ---or--- a subclinical sign/symptom (defined as a Gd enhancing lesion or a new T2 lesion demonstrated on MRI examination on a prior MRI that has been completed within 1 year of the screening MRI). The Screening (V-1) MRI should not be used for this determination. 7. No relapse in the 4 weeks prior to the screening visit (V-1). 8. Must be in a clinically stable or improving neurological state 4 weeks preceding the screening visit (V-1).
Exclusion criteria
Exclusion criteria: 1. Relapse at the baseline visit (V0) or occurring within 4 weeks prior to the screening visit (V-1) 2. Intake of glatiramer acetate within 3 months prior to the screening (V-1) visit 3. Intake of previous immunotherapy or immunosuppressant treatment, within 4 months prior to the screening (V-1) visit 4. Intake of or previously received therapy with cladribine or alemtuzumab 5. An active viral, bacterial, or systemic fungal infection within 1 week of baseline (V0) 6. Use of systemic steroids within 3 weeks prior to the screening (V-1) MRI 7. Progressive disease 8. Level of liver enzymes 2.5 x the upper limit of normal 9. Abnormal renal function (estimated Glomerular Filtration Rate [eGFR] 60 ml/min/1.73 m2 ) 10. Positive serology or history for Hepatitis B, C, or human immunodeficiency virus (HIV) 11. Serious or acute coronary diseases, defined by at least 1 of the following conditions: a. Clinical symptoms of ischemic heart disease b. ST elevation or depression 2 mm on the electrocardiogram (ECG) c. Clinical symptoms of cardiac failure and/or current medical treatment for cardiac failure d. Severe ventricular arrhythmia (frequent premature ventricular beats) e. Atrioventricular block at third level 12. Chronic use of non-steroidal anti-inflammatory drugs 13. History of any of the following: a. Severe depression or suicide attempt b. Uncontrolled seizure disorder c. Cancer, excluding adequately treated basal cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix d. Previous contrast reaction to gadolinium or any other contraindications to MRI (e.g., metal in the eye, pacemakers, aneurysm clip) 14. Allergy to human albumin or to mannitol 15. Excessive alcohol use or illicit drug use 16. Women who are breast feeding, pregnant, or planning to become pregnant, or are unwilling to use an effective birth control method while on study 17. Medical, psychiatric, or other conditions that compromise the patients ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study 18. Participation in any other study involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study Current participation in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and efficacy of NU100 in patients with relapsing remitting multiple sclerosis (RRMS) as compared to placebo and an active comparator.Timepoint: The cumulative number of new combined unique active lesions (CALs; defined as new gadolinium T1-weighted lesions and non enhancing new and newly enlarging T2-weighted lesions) on magnetic resonance imaging (MRI) scans over the course of 4 and 12 months of treatment to demonstrate the superiority of NU100 to placebo and the non-inferiority of NU100 to Betaferon®, respectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| The rates of reduction for a non-inferiority trial require several assumptions: an expected difference between the 2 active therapies, a tolerable difference and the variation found in the treatment groups along with Type I and Type II errors. If we assume that the 2 drugs are truly equivalent, then our expected difference is zero.Timepoint: Incidence of annualized relapse rates Proportion of relapse-free patients at 12 months Incidence and severity of all drug related flu-like symptoms during the first 4 months of study participation in all patients Incidence of antibody formation against IFN beta-1b Changes from baseline in the EDSS score after 3, 4, 6, 9, and 12 months of treatment Sustained change in EDSS measured for at least 3 months | — |
Countries
Belarus, Bulgaria, Croatia, France, Georgia, India, Italy, Poland, Russian Federation, Serbia, Spain, Ukraine
Contacts
Public ContactDr Krishnan Vijayan
Kovai Medical Center and Hospital Ltd
Outcome results
None listed