A Phase 2 interventional study of Interferon beta 1b (Betaseron, BAY86-5046) and Interferon beta 1b (Betaseron, BAY86-5046) in Multiple Sclerosis, Relapsing-Remitting, sponsored by Bayer. Completed at 17 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2014-05-08.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
The purpose of this study is to determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis.
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.
Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 63 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Extension Treatment 250 mcg continued
Drug: Interferon beta 1b (Betaseron, BAY86-5046)
Extension Treatment 500 mcg reduced to 250 mcg
Drug: Interferon beta 1b (Betaseron, BAY86-5046)
Extension Treatment 500 mcg continued
Drug: Interferon beta 1b (Betaseron, BAY86-5046)
Extension Treatment 250 mcg increased to 500 mcg
Drug: Interferon beta 1b (Betaseron, BAY86-5046)
250 mcg administered s.c.(subcutaneous) every other day
Also known as: Betaferon
250 mcg administered s.c. every other day (for patients having received 500 mcg before)
Also known as: Betaferon
500 mcg administered s.c. every other day
Also known as: Betaferon
500 mcg administered s.c. every other day (for patients having received 250 mcg before)
Also known as: Betaferon
Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities
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.
Time frame: At End of Study Visit (week 234)
Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b
Serum samples for analysis of NAbs to interferon (IFN) beta-1b were collected in Study 307000A. In the extension study, NAbs were also monitored for information on persistence or resolution. Serum samples of about 6 mL for NAbs were drawn at Weeks 10, 24, 52, 78, 104 130, 156, 182, 208, 234, 260, 286 or the EOS visit. (NU/ml=neutralizing units/ml).
Time frame: At End of Study Visit (week 234)
Eligible patients for this multi-center study included only those who completed in a predecessor study. Patients were enrolled at the end of the preceding study, from 03 Jun 2003 until 06 Jun 2003. Patients who interrupted study medication in accordance with the investigator were eligible, provided it did not result in premature End of Study (EOS).
| Milestone | ET: IFNB-1b 250 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 500 mcg | ET: IFNB-1b 250 mcg => 500 mcg | CT: IFNB-1b 250mcg | CT: IFNB-1b 500mcg |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 36 | 27 |
| Completed | 0 | 0 | 0 | 0 | 36 | 25 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 2 |
| Milestone | ET: IFNB-1b 250 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 500 mcg | ET: IFNB-1b 250 mcg => 500 mcg | CT: IFNB-1b 250mcg | CT: IFNB-1b 500mcg |
|---|---|---|---|---|---|---|
| Started | 16 | 6 | 19 | 20 | 0 | 0 |
| Completed | 8 | 2 | 14 | 14 | 0 | 0 |
| Not completed | 8 | 4 | 5 | 6 | 0 | 0 |
| Withdrew: Adverse event | 3 | 0 | 2 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 1 | 4 | 0 | 0 |
| Withdrew: ´other´ not further itemized | 2 | 3 | 1 | 2 | 0 | 0 |
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.
| participants | ET: IFNB-1b 250 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 500 mcg | ET: IFNB-1b 250 mcg => 500 mcg |
|---|---|---|---|---|
| Incidence of flu-like syndrome | 1 | 1 | 4 | 7 |
| Incidence of fever | 1 | 0 | 1 | 0 |
| Incidence of myalgia | 0 | 0 | 1 | 0 |
| Incidence of injection site reactions | 2 | 3 | 4 | 3 |
| Incidence of injection site reactions pain | 0 | 0 | 1 | 0 |
| Incidence of asthenia | 4 | 1 | 2 | 3 |
| Incidence of headache | 2 | 0 | 2 | 3 |
| Incidence of grade 1 toxicity (ALAT) | 4 | 1 | 8 | 9 |
| Incidence of grade 2 toxicity (ALAT) | 0 | 0 | 0 | 0 |
| Incidence of grade 3 toxicity (ALAT) | 0 | 0 | 0 | 0 |
| Incidence of grade 4 toxicity (ALAT) | 0 | 0 | 0 | 0 |
| Incidence of grade 1 toxicity (ASAT) | 2 | 1 | 8 | 7 |
| Incidence of grade 2 toxicity (ASAT) | 1 | 0 | 0 | 0 |
| Incidence of grade 3 toxicity (ASAT) | 0 | 0 | 0 | 0 |
| Incidence of grade 4 toxicity (ASAT) | 0 | 0 | 0 | 0 |
| Incidence of grade 1 toxicity (Bilirubin total) | 10 | 4 | 10 | 14 |
| Incidence of grade 2 toxicity (Bilirubin total) | 0 | 0 | 1 | 0 |
| Incidence of grade 3 toxicity (Bilirubin total) | 0 | 0 | 0 | 0 |
| Incidence of grade 4 toxicity (Bilirubin total) | 0 | 0 | 0 | 0 |
| Incidence of grade 1 toxicity (Leukocytes) | 3 | 3 | 4 | 6 |
| Incidence of grade 2 toxicity (Leukocytes) | 1 | 0 | 1 | 2 |
| Incidence of grade 3 toxicity (Leukocytes) | 0 | 0 | 0 | 0 |
| Incidence of grade 4 toxicity (Leukocytes) | 0 | 0 | 0 | 0 |
| Incidence of grade 1 toxicity (Lymphocytes) | 0 | 0 | 1 | 5 |
| Incidence of grade 2 toxicity (Lymphocytes) | 2 | 0 | 1 | 1 |
| Incidence of grade 3 toxicity (Lymphocytes) | 0 | 0 | 0 | 1 |
| Incidence of grade 4 toxicity (Lymphocytes) | 0 | 0 | 0 | 0 |
| Incidence of grade 1 toxicity (Platelets) | 0 | 0 | 0 | 0 |
| Incidence of grade 2 toxicity (Platelets) | 0 | 0 | 0 | 0 |
| Incidence of grade 3 toxicity (Platelets) | 0 | 0 | 0 | 0 |
| Incidence of grade 4 toxicity (Platelets) | 0 | 0 | 0 | 0 |
| Incidence of grade 1 toxicity (Hemoglobin) | 0 | 0 | 1 | 1 |
| Incidence of grade 2 toxicity (Hemoglobin) | 0 | 0 | 0 | 0 |
| Incidence of grade 3 toxicity (Hemoglobin) | 0 | 0 | 1 | 0 |
| Incidence of grade 4 toxicity (Hemoglobin) | 0 | 0 | 0 | 0 |
Serum samples for analysis of NAbs to interferon (IFN) beta-1b were collected in Study 307000A. In the extension study, NAbs were also monitored for information on persistence or resolution. Serum samples of about 6 mL for NAbs were drawn at Weeks 10, 24, 52, 78, 104 130, 156, 182, 208, 234, 260, 286 or the EOS visit. (NU/ml=neutralizing units/ml).
| participants | ET: IFNB-1b 250 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 500 mcg | ET: IFNB-1b 250 mcg => 500 mcg |
|---|---|---|---|---|
| NAbs titer, cut-off value 20 NU/ml (minimum) | 2 | 0 | 5 | 3 |
| NAbs titer, cut-off value 100 NU/ml (minimum) | 1 | 0 | 2 | 2 |
| NAbs titer, cut-off value 400 NU/ml (minimum) | 1 | 0 | 1 | 1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ET: IFNB-1b 250 mcg => 250 mcg | — | 2/16 (12.5%) | 15/16 (93.8%) |
| ET: IFNB-1b 500 mcg => 250 mcg | — | 0/6 (0%) | 6/6 (100%) |
| ET: IFNB-1b 500 mcg => 500 mcg | — | 9/19 (47.4%) | 19/19 (100%) |
| ET: IFNB-1b 250 mcg => 500 mcg | — | 4/20 (20%) | 20/20 (100%) |
| Event | ET: IFNB-1b 250 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 500 mcg | ET: IFNB-1b 250 mcg => 500 mcg |
|---|---|---|---|---|
| Cerebrovascular AccidentNervous system disorders | 1/16 | 0/6 | 1/19 | 0/20 |
| PericarditisCardiac disorders | 1/16 | 0/6 | 0/19 | 0/20 |
| HeadacheNervous system disorders | 1/16 | 0/6 | 1/19 | 0/20 |
| BronchitisInfections and infestations | 1/16 | 0/6 | 0/19 | 0/20 |
| Otitis MediaInfections and infestations | 1/16 | 0/6 | 0/19 | 0/20 |
| Endometrial DisorderReproductive system and breast disorders | 1/16 | 0/6 | 0/19 | 0/20 |
| Kidney CalculusRenal and urinary disorders | 1/16 | 0/6 | 1/19 | 0/20 |
| Abdominal PainGastrointestinal disorders | 0/16 | 0/6 | 1/19 | 0/20 |
| ChillsGeneral disorders | 0/16 | 0/6 | 1/19 | 0/20 |
| FeverGeneral disorders | 0/16 | 0/6 | 1/19 | 0/20 |
| Event | ET: IFNB-1b 250 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 500 mcg | ET: IFNB-1b 250 mcg => 500 mcg |
|---|---|---|---|---|
| Injection Site ReactionGeneral disorders | 2/16 | 3/6 | 4/19 | 3/20 |
| DepressionPsychiatric disorders | 4/16 | 3/6 | 4/19 | 0/20 |
| HypesthesiaNervous system disorders | 5/16 | 3/6 | 7/19 | 9/20 |
| Multiple SclerosisNervous system disorders | 4/16 | 3/6 | 2/19 | 6/20 |
| ParesthesiaNervous system disorders | 5/16 | 3/6 | 7/19 | 5/20 |
| Flu SyndromInfections and infestations | 1/16 | 1/6 | 4/19 | 7/20 |
| MyastheniaMusculoskeletal and connective tissue disorders | 3/16 | 2/6 | 3/19 | 7/20 |
| Upper Respiratory InfectionInfections and infestations | 5/16 | 1/6 | 2/19 | 7/20 |
| PainGeneral disorders | 2/16 | 2/6 | 4/19 | 5/20 |
| Urinary Tract InfectionInfections and infestations | 4/16 | 0/6 | 6/19 | 3/20 |
| Age, Continuous(years) | ET: IFNB-1b 250 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 500 mcg | ET: IFNB-1b 250 mcg => 500 mcg | Total |
|---|---|---|---|---|---|
| Mean | 37.8 ± 9.22 | 32.2 ± 6.79 | 38.8 ± 7.57 | 39.3 ± 7.17 | 38.1 ± 7.98 |
| Age, Customized(participants) | ET: IFNB-1b 250 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 500 mcg | ET: IFNB-1b 250 mcg => 500 mcg | Total |
|---|---|---|---|---|---|
| >20-30 years | 3 | 2 | 3 | 1 | 9 |
| >30-40 years | 7 | 3 | 6 | 10 | 26 |
| >40-50 years | 4 | 1 | 8 | 8 | 21 |
| >50 years | 2 | 0 | 2 | 1 | 5 |
| Sex: Female, Male(Participants) | ET: IFNB-1b 250 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 500 mcg | ET: IFNB-1b 250 mcg => 500 mcg | Total |
|---|---|---|---|---|---|
| Female | 14 | 3 | 15 | 12 | 44 |
| Male | 2 | 3 | 4 | 8 | 17 |
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