A Phase 3 interventional study of Interferon-beta-1a FBS-free/HSA-free in Multiple Sclerosis, sponsored by EMD Serono. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-07-15.
Sponsored by EMD Serono · Phase 3, Interventional, and Treatment
The primary objective of the study is to compare the immunogenicity of the new fetal bovine serum (FBS)-free/human serum albumin (HSA)-free Rebif® formulation (RNF) to historical data.
As has been seen with other recombinant protein molecules, the use of injectable recombinant proteins may result in the development of neutralising antibodies (NAbs). Antibodies are considered neutralising by their ability to inhibit the biological effect of interferon in a bioassay system. EMD Serono has actively pursued improvements in the formulation of interferon (IFN) beta-1a to reduce aggregate levels and to develop a formulation that is HSA-free. Reducing aggregates should reduce antigenicity of the product while removal of HSA may have an unpredictable effect on antigenicity. EMD Serono will conduct a study to assess the immunogenicity and safety of the new HSA-free formulation, manufactured using IFN-ß-1a drug substance produced by a new clone from the FBS-free process.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 260 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →EMD Serono is the lead sponsor of 88 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: Interferon-beta-1a FBS-free/HSA-free
Pre-filled syringes 44mcg/injected subcutaneous 3x per week. Total study period is 96 weeks.
Number of Participants Who Were Neutralising Antibody (NAb) Positive at the Week 96 Visit.
The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.
Time frame: 96 weeks
Number of Participants Who Were Neutralising Antibody (NAb) Positive at Anytime During the Study
The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.
Time frame: 96 weeks
Number of Participants With Binding Antibodies (BAb) at Week 96
Presence of BAbs. BAbs were measured by ELISA (Enzyme-linked immunosorbent assay).
Time frame: 96 weeks
Participants were enrolled from 25 Jan 2005 and attended the last visit on 16 April 2007. Two hundred and eighty two participants were screened for enrollment and 260 were enrolled.
| Milestone | Rebif New Formulation (RNF) Cohort |
|---|---|
| Started | 260 |
| Completed | 224 |
| Not completed | 36 |
| Withdrew: Adverse event | 15 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Administration of plasmapheresis | 1 |
| Withdrew: Initiated mitoxantrone therapy | 1 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Decided not to continue treatment | 1 |
| Withdrew: Patient non-compliance | 1 |
| Withdrew: Patient refused to continue | 1 |
| Withdrew: Patient refused to participate | 1 |
| Withdrew: Patient will | 1 |
| Withdrew: Patient's decision | 1 |
| Withdrew: Participation in ms vaccine study | 1 |
| Withdrew: Pregnancy | 1 |
| Withdrew: Pregnancy (protocol violation) | 2 |
| Withdrew: Protocol violation | 2 |
| Withdrew: Patient refused to come back | 1 |
| Withdrew: The patient has refused | 2 |
| Withdrew: The patient has refused to visit site | 1 |
| Withdrew: Patient is to be administered copaxone | 1 |
The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.
| participants | Rebif New Formulation (RNF) Cohort |
|---|---|
| Number of Participants Who Were Neutralising Antibody (NAb) Positive at the Week 96 Visit. | 45 |
The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.
| participants | Rebif New Formulation (RNF) Cohort |
|---|---|
| Number of Participants Who Were Neutralising Antibody (NAb) Positive at Anytime During the Study | 49 |
Presence of BAbs. BAbs were measured by ELISA (Enzyme-linked immunosorbent assay).
| Participants | Rebif New Formulation (RNF) Cohort |
|---|---|
| Number of Participants With Binding Antibodies (BAb) at Week 96 | 74 |
Collected over Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rebif New Formulation (RNF) Cohort | — | 15/260 (5.8%) | 247/260 (95%) |
| Event | Rebif New Formulation (RNF) Cohort |
|---|---|
| DepressionPsychiatric disorders | 3/260 |
| Drug toxicityInjury, poisoning and procedural complications | 1/260 |
| Humerus fractureInjury, poisoning and procedural complications | 1/260 |
| Joint dislocationInjury, poisoning and procedural complications | 1/260 |
| Limb injuryInjury, poisoning and procedural complications | 1/260 |
| Near drowningInjury, poisoning and procedural complications | 1/260 |
| HypomaniaPsychiatric disorders | 1/260 |
| EndometriosisReproductive system and breast disorders | 1/260 |
| Menstrual disorderReproductive system and breast disorders | 1/260 |
| Ovarian cyst rupturedReproductive system and breast disorders | 1/260 |
| Event | Rebif New Formulation (RNF) Cohort |
|---|---|
| Influenza like illnessGeneral disorders | 176/260 |
| HeadacheNervous system disorders | 98/260 |
| Injection site erythemaGeneral disorders | 63/260 |
| NauseaGastrointestinal disorders | 26/260 |
| Back painMusculoskeletal and connective tissue disorders | 26/260 |
| Injection site haemorrhageGeneral disorders | 25/260 |
| FatigueGeneral disorders | 24/260 |
| Upper respiratory tract infectionInfections and infestations | 23/260 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 21/260 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 20/260 |
| Age, Categorical(Participants) | Rebif New Formulation (RNF) Cohort |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 260 |
| >=65 years | 0 |
| Age, Continuous(years) | Rebif New Formulation (RNF) Cohort |
|---|---|
| Mean | 34.9 ± 9.5 |
| Sex: Female, Male(Participants) | Rebif New Formulation (RNF) Cohort |
|---|---|
| Female | 186 |
| Male | 74 |
| Region of Enrollment(participants) | Rebif New Formulation (RNF) Cohort |
|---|---|
| Argentina | 14 |
| Australia | 10 |
| Canada | 4 |
| Denmark | 4 |
| Ireland | 4 |
| Israel | 4 |
| Lithuania | 20 |
| Russian Federation | 134 |
| Spain | 13 |
| Sweden | 5 |
| United Kingdom | 23 |
| United States | 25 |
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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