Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication BETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BETASERON is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive… FDA label
Interferon beta 1b · 7 trials · 5 indications
The variable "Flu-like-syndrome" will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition.
The variable "Injection-site reactions" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
The variable "Liver enzyme elevations" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
The variable "Hematological abnormalities" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
The primary efficacy variable was calculated by subtracting the number of newly active lesions during the 3-month pre-treatment period from the cumulative number of newly active lesions during the 6-month treatment period divided by 2 (number of newly active lesions per three months, new lesion frequency per 3 months)
CDMS could be reached due to a qualifying relapse or sustained progression of 1.5 points on the expanded disability status scale (EDSS) as compared to the lowest EDSS obtained during screening or Day 1. The validity of CDMS diagnoses was confirmed by a central committee. The EDSS scale quantifies disability in MS in 8 functional systems, values vary between 0="normal neurological examination" and 10="death due to MS" measured in half-points on an ordinal scale. Time to CDMS = date of CDMS - date of Day 1 + 1 or time to CDMS = date of last clinical visit - date of Day 1 + 1 (right-censored)
EDSS progression was defined as an increase in the expanded disability status scale (EDSS) of 1.0 point compared to the lowest EDSS score obtained during the screening or baseline visit, if this score was \<= 5.5. A confirmed EDSS progression status was defined as an EDSS progression observed at two consecutive scheduled visits at least 140 days apart from each other. The EDSS scale is a method of quantifying disability in multiple sclerosis in eight functional systems and values vary between 0="normal neurological examination" and 10="death due to MS" measured in half-points on a scale.
As an index of health related quality of life in people diagnosed with MS, the FAMS Trial Outcome Index covers overall physical health (sum of sub-scale scores Mobility, Symptoms, Thinking/Fatigue, Additional Concerns) with a score range from 0 to 148. A higher score reflects a higher overall physical health as reported by patients.
Outcome measures are given as the number of patients with common toxicity by the Common Toxicity Criteria (CTC). Toxicity grading is: Grade 1: no study drug action recommended, Grade 2: Dose reduction or interruption of study treatment should be considered (grade 2 Lymphocyte toxicity required no study drug action), Grade 3: Dose reduction or interruption should be considered; interruption is recommended, and Grade 4: Interruption of study drug is recommended (Grade 4 laboratory toxicity was reported as a serious adverse event). Liver and bone marrow abnormalities are measured by lab tests.
| Arm | Type | Description |
|---|---|---|
| IFNB-1b 500 mcg | EXPERIMENTAL | Interferon beta 1b (\[IFNB 1b\] Betaseron) 500 mcg administered s.c. every other day (double blind) |
| IFNB-1b 250 mcg | EXPERIMENTAL | Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day (double blind) |
| IFNB-1b 250 mcg* | EXPERIMENTAL | Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day \*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.) |
| Interferon beta-1b (Betaseron, BAY86-5046) | EXPERIMENTAL | Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.) |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 3 | ACTIVE_COMPARATOR | - |
| Initial IFNB-1b (Interferon beta-1b) | EXPERIMENTAL | Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase |
| Initial Placebo | EXPERIMENTAL | Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial) |
| ET: IFNB-1b 250 mcg => 250 mcg | ACTIVE_COMPARATOR | Extension Treatment 250 mcg continued |
| ET: IFNB-1b 500 mcg => 250 mcg | EXPERIMENTAL | Extension Treatment 500 mcg reduced to 250 mcg |
| ET: IFNB-1b 500 mcg => 500 mcg | EXPERIMENTAL | Extension Treatment 500 mcg continued |
| ET: IFNB-1b 250 mcg => 500 mcg | EXPERIMENTAL | Extension Treatment 250 mcg increased to 500 mcg |
| Arm 4 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Interferon beta-1b (Betaseron, BAY86-5046) | DRUG | Phase A: 250ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label). |
| Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) | DRUG | 250mcg administered s.c. every other day |
| Copaxone | DRUG | 20 mg administered s.c. once daily. |
| Interferon beta-1b | DRUG | - |
| Zidovudine | DRUG | - |
| Interferon beta 1b (Betaseron, BAY86-5046) | DRUG | 250 mcg administered s.c.(subcutaneous) every other day |
| Placebo | DRUG | 0.25 ml in week 1 and 0.50 ml in weeks 2 to 24 given subcutaneously every other day |
Inclusion Criteria: * Completion of the BEYOND study 306440 as scheduled * Relapsing multiple sclerosis * Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be ...
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|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
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| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
Interferon beta 1b is used to treat relapsing-remitting multiple sclerosis and is also being studied in chronic viral cardiomyopathies and HIV infections. It is a small molecule developed by Bayer AG under the ticker BAYRY. The multiple sclerosis indication has the most clinical trial activity, including Phase 3 studies.
Interferon beta 1b is developed by Bayer AG, which trades under the ticker BAYRY. Bayer has sponsored multiple clinical trials of the drug, including the BEYOND follow-up study and an open-label study in Chinese patients with multiple sclerosis.
Interferon beta 1b is in Phase 2 development for cardiomyopathies and HIV infections, while it has been studied in Phase 3 trials for multiple sclerosis. The Phase 2 trial in chronic viral cardiomyopathy completed with 138 patients, and the Phase 3 multiple sclerosis trials have also completed.
Interferon beta 1b has been evaluated in several completed trials, including NCT00459667 (BEYOND follow-up, Phase 3, 1,420 patients with relapsing-remitting multiple sclerosis), NCT00370071 (Phase 3, 39 patients in China), NCT00235989 (Phase 2 extension, 63 patients), and NCT00185250 (Phase 2, 138 patients with chronic viral cardiomyopathy).
Yes, Interferon beta 1b is also known as Betaseron and Betaferon, and it has the development code BAY86-5046. These names refer to the same drug developed by Bayer AG. Betaseron and Betaferon are brand names used in different regions.