Trial Outcomes & Findings for Study To Evaluate The Immunogenicity And Safety Of r-hIFN Beta-1a (Rebif®) Using Clone 484-39 In Multiple Sclerosis (NCT NCT00367484)
NCT ID: NCT00367484
Last Updated: 2014-02-27
Results Overview
Participants who were NAb+ at 48 weeks (or at the last available NAb assessment up to Week 48). The NAb+ value was defined as NAb ≥ 20 NU/ml.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
460 participants
Primary outcome timeframe
48 Weeks
Results posted on
2014-02-27
Participant Flow
Subjects were screened for enrollment from 27 May 2004 and attended the last visit on 30 January 2006. Four hundred and eighty four subjects were screened for enrollment and 460 were enrolled. Two subjects (0.4%) were excluded from the ITT Population since they had no post-Baseline NAb assessment due to withdrawing from the study prematurely.
At Week -4 (to Week -1), subjects provided written informed consent and underwent screening procedures. Twenty four subjects were not included in the study: the reasons were "Not met all eligibility criteria" (18 subjects) and "Other" (6 subjects)
Participant milestones
| Measure |
Rebif® (Clone 484-39)
subcutaneously administered Rebif® 44mcg three times per week
|
|---|---|
|
Overall Study
STARTED
|
460
|
|
Overall Study
COMPLETED
|
443
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Rebif® (Clone 484-39)
subcutaneously administered Rebif® 44mcg three times per week
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Withdrew informed consent
|
5
|
|
Overall Study
Travel to USA
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
The choice of the patient
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Study To Evaluate The Immunogenicity And Safety Of r-hIFN Beta-1a (Rebif®) Using Clone 484-39 In Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Rebif® (Clone 484-39)
n=458 Participants
subcutaneously administered Rebif® 44mcg three times per week
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
458 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
36.0 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
336 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
36 participants
n=5 Participants
|
|
Region of Enrollment
France
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
69 participants
n=5 Participants
|
|
Region of Enrollment
Morocco
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
69 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
87 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
80 participants
n=5 Participants
|
|
Region of Enrollment
Tunisia
|
31 participants
n=5 Participants
|
|
Neutralising Antibody (NAb) Status
|
458 Participants not testing NAb positive
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 WeeksPopulation: Intent To Treat (ITT) population, Last Observation Carried Forward (LOCF)
Participants who were NAb+ at 48 weeks (or at the last available NAb assessment up to Week 48). The NAb+ value was defined as NAb ≥ 20 NU/ml.
Outcome measures
| Measure |
Rebif® (Clone 484-39)
n=458 Participants
subcutaneously administered Rebif® 44mcg three times per week
|
|---|---|
|
Number of Participants Testing Positive for Neutralising Antibody (NAb)
|
73 NAb+ participants
|
Adverse Events
Rebif® (Clone 484-39)
Serious events: 11 serious events
Other events: 378 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rebif® (Clone 484-39)
n=460 participants at risk
subcutaneously administered Rebif® 44mcg three times per week
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.43%
2/460 • Number of events 2 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Infections and infestations
Herpes zoster
|
0.22%
1/460 • Number of events 1 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Infections and infestations
Injection site abscess
|
0.22%
1/460 • Number of events 1 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Infections and infestations
Injection site cellulitis
|
0.22%
1/460 • Number of events 1 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Infections and infestations
Urinary tract infection
|
0.22%
1/460 • Number of events 1 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.22%
1/460 • Number of events 1 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Injury, poisoning and procedural complications
Fall
|
0.22%
1/460 • Number of events 1 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.22%
1/460 • Number of events 1 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.22%
1/460 • Number of events 1 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage I
|
0.22%
1/460 • Number of events 1 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.22%
1/460 • Number of events 1 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Cardiac disorders
Angina pectoris
|
0.22%
1/460 • Number of events 1 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.22%
1/460 • Number of events 1 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Immune system disorders
Drug hypersensitivity
|
0.22%
1/460 • Number of events 1 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.22%
1/460 • Number of events 1 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.22%
1/460 • Number of events 1 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
Other adverse events
| Measure |
Rebif® (Clone 484-39)
n=460 participants at risk
subcutaneously administered Rebif® 44mcg three times per week
|
|---|---|
|
General disorders
Influenza like illness
|
40.9%
188/460 • Number of events 284 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
General disorders
Injection site erythema
|
14.6%
67/460 • Number of events 71 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
General disorders
Pyrexia
|
10.9%
50/460 • Number of events 57 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
General disorders
Fatigue
|
8.0%
37/460 • Number of events 40 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
General disorders
Chills
|
7.6%
35/460 • Number of events 39 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
General disorders
Asthenia
|
6.3%
29/460 • Number of events 35 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Nervous system disorders
Headache
|
28.0%
129/460 • Number of events 208 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
37/460 • Number of events 45 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Infections and infestations
Influenza
|
7.0%
32/460 • Number of events 58 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
27/460 • Number of events 32 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.3%
43/460 • Number of events 53 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
26/460 • Number of events 36 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Gastrointestinal disorders
Nausea
|
5.2%
24/460 • Number of events 26 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Investigations
Alanine aminotransferase increased
|
5.4%
25/460 • Number of events 26 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Psychiatric disorders
Insomnia
|
6.7%
31/460 • Number of events 34 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
8.7%
40/460 • Number of events 53 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
7.8%
36/460 • Number of events 56 • 48 weeks
Comprehensive assessments of any apparent toxicity experienced by the subject were performed throughout the course of the study. Study site personnel reported any AE, whether observed by the Investigator or reported by the subject.
|
Additional Information
Bettina Stubinski/Senior Medical Director
Merck Serono, a division of Merck KGaA, Darmstadt, Germany
Phone: +49 6151 72 5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER