Approval Probability
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Interferon beta 1b · 2 trials · 1 indication
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.
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.) |
| 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 |
| 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 (Betaseron, BAY86-5046) | DRUG | 250 mcg administered s.c.(subcutaneous) 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 ...
Interferon beta 1b is used for the treatment of multiple sclerosis, including relapsing-remitting multiple sclerosis, and is also being studied for HIV infections. It is developed by Bayer AG (ticker: BAYRY) and is currently in Phase 3 clinical development for these indications.
Interferon beta 1b is a small molecule that works by modulating the immune system to reduce inflammation and prevent nerve damage in multiple sclerosis. It is a type of interferon beta, which has antiviral and immunomodulatory properties, helping to decrease the frequency and severity of relapses in patients with relapsing-remitting multiple sclerosis.
Interferon beta 1b is developed by Bayer AG, a multinational pharmaceutical company headquartered in Germany. Bayer AG is publicly traded under the ticker symbol BAYRY on the OTC market. The drug is being investigated for multiple sclerosis and HIV infections.
Interferon beta 1b is currently in Phase 3 clinical development for multiple sclerosis and HIV infections. It has completed several Phase 3 trials, including the BENEFIT study and the BEYOND follow-up study, which evaluated its efficacy and safety in patients with multiple sclerosis.
Interferon beta 1b has been studied in several clinical trials, including NCT00185211 (BENEFIT study), NCT00235989 (extension study), NCT00370071 (study in Chinese patients), and NCT00459667 (BEYOND follow-up). These trials have been completed and involved patients with multiple sclerosis, including relapsing-remitting forms.
Yes, Interferon beta 1b is also known as Betaseron or Betaferon. These are brand names for the same drug, which is used to treat multiple sclerosis. In clinical trials, it has been referred to as Betaferon or Betaseron, and it is being developed by Bayer AG.