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Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis (RNF)

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ClinicalTrials.gov Identifier: NCT00110396
Recruitment Status : Completed
First Posted : May 9, 2005
Results First Posted : July 9, 2010
Last Update Posted : July 15, 2015
Sponsor:
Collaborator:
Pfizer
Information provided by:
EMD Serono

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Intervention Biological: Interferon-beta-1a FBS-free/HSA-free
Enrollment 260
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Rebif New Formulation (RNF) Cohort
Hide Arm/Group Description Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
Period Title: Overall Study
Started 260
Completed 224 [1]
Not Completed 36
Reason Not Completed
Adverse Event             15
Lost to Follow-up             1
Administration of plasmapheresis             1
Initiated mitoxantrone therapy             1
Lack of Efficacy             1
Decided not to continue treatment             1
Patient non-compliance             1
Patient refused to continue             1
Patient refused to participate             1
Patient will             1
Patient's decision             1
Participation in MS vaccine study             1
Pregnancy             1
Pregnancy (Protocol violation)             2
Protocol Violation             2
Patient refused to come back             1
The patient has refused             2
The patient has refused to visit site             1
Patient is to be administered copaxone             1
[1]
260 participants included in the Safety Population.207 completed treatment. 224 completed the trial
Arm/Group Title Rebif New Formulation (RNF) Cohort
Hide Arm/Group Description Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
Overall Number of Baseline Participants 260
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 260 participants
<=18 years
0
   0.0%
Between 18 and 65 years
260
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 260 participants
34.9  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 260 participants
Female
186
  71.5%
Male
74
  28.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 260 participants
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
1.Primary Outcome
Title Number of Participants Who Were Neutralising Antibody (NAb) Positive at the Week 96 Visit.
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (One participant did not have any post-baseline NAb assessments). LOCF imputation
Arm/Group Title Rebif New Formulation (RNF) Cohort
Hide Arm/Group Description:
Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
Overall Number of Participants Analyzed 259
Measure Type: Number
Unit of Measure: participants
45
2.Secondary Outcome
Title Number of Participants Who Were Neutralising Antibody (NAb) Positive at Anytime During the Study
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (One participant did not have any post-baseline NAb assessments). LOCF imputation
Arm/Group Title Rebif New Formulation (RNF) Cohort
Hide Arm/Group Description:
Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
Overall Number of Participants Analyzed 259
Measure Type: Number
Unit of Measure: participants
49
3.Secondary Outcome
Title Number of Participants With Binding Antibodies (BAb) at Week 96
Hide Description Presence of BAbs. BAbs were measured by ELISA (Enzyme-linked immunosorbent assay).
Time Frame 96 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (One participant did not have any post-baseline NAb assessments) LOCF imputation
Arm/Group Title Rebif New Formulation (RNF) Cohort
Hide Arm/Group Description:
Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
Overall Number of Participants Analyzed 259
Measure Type: Number
Unit of Measure: Participants
74
Time Frame Adverse event reporting began at signature of informed consent and continued until 4 weeks after the last administration of trial medication.
Adverse Event Reporting Description Investigator recorded AE's at every visit.
 
Arm/Group Title Rebif New Formulation (RNF) Cohort
Hide Arm/Group Description Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
All-Cause Mortality
Rebif New Formulation (RNF) Cohort
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Rebif New Formulation (RNF) Cohort
Affected / at Risk (%) # Events
Total   15/260 (5.77%)    
Cardiac disorders   
Angina unstable  1  1/260 (0.38%)  1
Gastrointestinal disorders   
Coeliac disease  1  1/260 (0.38%)  1
Periproctitis  1  1/260 (0.38%)  1
Infections and infestations   
Pneumonia  1  1/260 (0.38%)  1
Injury, poisoning and procedural complications   
Drug toxicity  1  1/260 (0.38%)  1
Humerus fracture  1  1/260 (0.38%)  1
Joint dislocation  1  1/260 (0.38%)  1
Limb injury  1  1/260 (0.38%)  1
Near drowning  1  1/260 (0.38%)  1
Investigations   
Alanine aminotransferase increased  1  1/260 (0.38%)  1
Aspartate aminotransferase increased  1  1/260 (0.38%)  1
Metabolism and nutrition disorders   
Diabetes mellitus non-insulin-dependent  1  1/260 (0.38%)  1
Psychiatric disorders   
Depression  1  3/260 (1.15%)  3
Hypomania  1  1/260 (0.38%)  1
Renal and urinary disorders   
Renal colic  1  1/260 (0.38%)  1
Reproductive system and breast disorders   
Endometriosis  1  1/260 (0.38%)  1
Menstrual disorder  1  1/260 (0.38%)  1
Ovarian cyst ruptured  1  1/260 (0.38%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rebif New Formulation (RNF) Cohort
Affected / at Risk (%) # Events
Total   247/260 (95.00%)    
Blood and lymphatic system disorders   
Neutropenia  1  18/260 (6.92%)  23
Gastrointestinal disorders   
Nausea  1  26/260 (10.00%)  34
Diarrhoea  1  17/260 (6.54%)  21
Vomiting  1  13/260 (5.00%)  16
General disorders   
Influenza like illness  1  176/260 (67.69%)  329
Injection site erythema  1  63/260 (24.23%)  76
Injection site haemorrhage  1  25/260 (9.62%)  30
Fatigue  1  24/260 (9.23%)  26
Pyrexia  1  18/260 (6.92%)  32
Chills  1  18/260 (6.92%)  24
Injection site pain  1  17/260 (6.54%)  21
Asthenia  1  16/260 (6.15%)  25
Infections and infestations   
Upper respiratory tract infection  1  23/260 (8.85%)  36
Nasopharyngitis  1  17/260 (6.54%)  22
Viral upper respiratory tract infection  1  15/260 (5.77%)  25
Urinary tract infection  1  14/260 (5.38%)  27
Investigations   
Alanine aminotransferase increased  1  19/260 (7.31%)  22
Aspartate aminotransferase increased  1  15/260 (5.77%)  19
Musculoskeletal and connective tissue disorders   
Back pain  1  26/260 (10.00%)  31
Arthralgia  1  21/260 (8.08%)  32
Pain in extremity  1  20/260 (7.69%)  26
Nervous system disorders   
Headache  1  98/260 (37.69%)  229
Dizziness  1  19/260 (7.31%)  22
Psychiatric disorders   
Insomnia  1  13/260 (5.00%)  14
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Bettina Stubinski/Medical Responsible
Organization: Merck Serono SA
Phone: +41224143396
Responsible Party: Susan Fischer, EMD Serono Inc
ClinicalTrials.gov Identifier: NCT00110396     History of Changes
Other Study ID Numbers: 25632
First Submitted: May 6, 2005
First Posted: May 9, 2005
Results First Submitted: April 30, 2010
Results First Posted: July 9, 2010
Last Update Posted: July 15, 2015