Trial Outcomes & Findings for Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis (NCT NCT00110396)
NCT ID: NCT00110396
Last Updated: 2015-07-15
Results Overview
The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
260 participants
Primary outcome timeframe
96 weeks
Results posted on
2015-07-15
Participant Flow
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.
Screening phase of up to 28 days before the start of interferon-beta-1a treatment. There were 47 centres in: Argentina (5), Australia (4),Canada (1), Denmark (1),Ireland (2), Israel (2), Lithuania(2), Russia (10), Spain (4), Sweden (1), UK (5) and US (10). 1 additional centre in Australia screened 1 participant who was not enrolled into the trial.
Participant milestones
| Measure |
Rebif New Formulation (RNF) Cohort
Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
|
|---|---|
|
Overall Study
STARTED
|
260
|
|
Overall Study
COMPLETED
|
224
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
Rebif New Formulation (RNF) Cohort
Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
|
|---|---|
|
Overall Study
Adverse Event
|
15
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Administration of plasmapheresis
|
1
|
|
Overall Study
Initiated mitoxantrone therapy
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Decided not to continue treatment
|
1
|
|
Overall Study
Patient non-compliance
|
1
|
|
Overall Study
Patient refused to continue
|
1
|
|
Overall Study
Patient refused to participate
|
1
|
|
Overall Study
Patient will
|
1
|
|
Overall Study
Patient's decision
|
1
|
|
Overall Study
Participation in MS vaccine study
|
1
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Pregnancy (Protocol violation)
|
2
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Patient refused to come back
|
1
|
|
Overall Study
The patient has refused
|
2
|
|
Overall Study
The patient has refused to visit site
|
1
|
|
Overall Study
Patient is to be administered copaxone
|
1
|
Baseline Characteristics
Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Rebif New Formulation (RNF) Cohort
n=260 Participants
Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
260 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
186 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
134 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
23 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 96 weeksPopulation: ITT (One participant did not have any post-baseline NAb assessments). LOCF imputation
The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.
Outcome measures
| Measure |
Rebif New Formulation (RNF) Cohort
n=259 Participants
Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
|
|---|---|
|
Number of Participants Who Were Neutralising Antibody (NAb) Positive at the Week 96 Visit.
|
45 participants
|
SECONDARY outcome
Timeframe: 96 weeksPopulation: ITT (One participant did not have any post-baseline NAb assessments). LOCF imputation
The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.
Outcome measures
| Measure |
Rebif New Formulation (RNF) Cohort
n=259 Participants
Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
|
|---|---|
|
Number of Participants Who Were Neutralising Antibody (NAb) Positive at Anytime During the Study
|
49 participants
|
SECONDARY outcome
Timeframe: 96 weeksPopulation: ITT (One participant did not have any post-baseline NAb assessments) LOCF imputation
Presence of BAbs. BAbs were measured by ELISA (Enzyme-linked immunosorbent assay).
Outcome measures
| Measure |
Rebif New Formulation (RNF) Cohort
n=259 Participants
Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
|
|---|---|
|
Number of Participants With Binding Antibodies (BAb) at Week 96
|
74 Participants
|
Adverse Events
Rebif New Formulation (RNF) Cohort
Serious events: 15 serious events
Other events: 247 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rebif New Formulation (RNF) Cohort
n=260 participants at risk
Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
|
|---|---|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.38%
1/260 • Number of events 1 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.38%
1/260 • Number of events 1 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.38%
1/260 • Number of events 1 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.38%
1/260 • Number of events 1 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.38%
1/260 • Number of events 1 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Psychiatric disorders
Depression
|
1.2%
3/260 • Number of events 3 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Psychiatric disorders
Hypomania
|
0.38%
1/260 • Number of events 1 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.38%
1/260 • Number of events 1 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.38%
1/260 • Number of events 1 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.38%
1/260 • Number of events 1 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.38%
1/260 • Number of events 1 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Gastrointestinal disorders
Periproctitis
|
0.38%
1/260 • Number of events 1 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Investigations
Alanine aminotransferase increased
|
0.38%
1/260 • Number of events 1 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Investigations
Aspartate aminotransferase increased
|
0.38%
1/260 • Number of events 1 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Cardiac disorders
Angina unstable
|
0.38%
1/260 • Number of events 1 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Infections and infestations
Pneumonia
|
0.38%
1/260 • Number of events 1 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Metabolism and nutrition disorders
Diabetes mellitus non-insulin-dependent
|
0.38%
1/260 • Number of events 1 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Renal and urinary disorders
Renal colic
|
0.38%
1/260 • Number of events 1 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
Other adverse events
| Measure |
Rebif New Formulation (RNF) Cohort
n=260 participants at risk
Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
|
|---|---|
|
General disorders
Pyrexia
|
6.9%
18/260 • Number of events 32 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
General disorders
Chills
|
6.9%
18/260 • Number of events 24 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.9%
18/260 • Number of events 23 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
17/260 • Number of events 22 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
17/260 • Number of events 21 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
General disorders
Injection site pain
|
6.5%
17/260 • Number of events 21 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
General disorders
Asthenia
|
6.2%
16/260 • Number of events 25 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.8%
15/260 • Number of events 25 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Investigations
Aspartate aminotransferase increased
|
5.8%
15/260 • Number of events 19 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Infections and infestations
Urinary tract infection
|
5.4%
14/260 • Number of events 27 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
13/260 • Number of events 16 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Psychiatric disorders
Insomnia
|
5.0%
13/260 • Number of events 14 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
26/260 • Number of events 31 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
General disorders
Injection site haemorrhage
|
9.6%
25/260 • Number of events 30 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
General disorders
Fatigue
|
9.2%
24/260 • Number of events 26 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.8%
23/260 • Number of events 36 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.1%
21/260 • Number of events 32 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
20/260 • Number of events 26 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Investigations
Alanine aminotransferase increased
|
7.3%
19/260 • Number of events 22 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Nervous system disorders
Dizziness
|
7.3%
19/260 • Number of events 22 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
General disorders
Influenza like illness
|
67.7%
176/260 • Number of events 329 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Nervous system disorders
Headache
|
37.7%
98/260 • Number of events 229 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
General disorders
Injection site erythema
|
24.2%
63/260 • Number of events 76 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
26/260 • Number of events 34 • Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Investigator recorded AE's at every visit.
|
Additional Information
Bettina Stubinski/Medical Responsible
Merck Serono SA
Phone: +41224143396
Results disclosure agreements
- Principal investigator is a sponsor employee SPONSOR shall have the right to publish or present any results or information, including the Study Results, arising in connection with the STUDY for any purposes. The INSTITUTION, its officers, agents, employees and affiliated entities shall not publish or use any results or information arising in connection with the STUDY, including the Study Results, for professional, research, training or other purposes without SPONSOR's prior written consent.
- Publication restrictions are in place
Restriction type: OTHER