Trial Outcomes & Findings for RNF and Betaseron® Tolerability Study (NCT NCT00428584)
NCT ID: NCT00428584
Last Updated: 2013-08-07
Results Overview
Subject reported perception of pain on the VAS where the slash drawn by the patient represents pain of increasing intensity from 0 (no pain) to 100 (worse possible pain), measured in millimeters. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 30 minutes post-injection
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
129 participants
Primary outcome timeframe
From pre-injection to 30 minutes post injection of the VAS pain scores across the first 21 injections of full dose therapy of a new formulation of rebif and Betaseron
Results posted on
2013-08-07
Participant Flow
129 subjects were recruited from 27 Multiple Sclerosis (MS) Clinics in the US from December 2006 through August 2007.
Subjects had a pre-study evaluation period (screening) within 14 days of Study Day 1 which consisted of informed consent, medical/disease history, physical exam and laboratory assessments.
Participant milestones
| Measure |
New Formulation of Rebif
The new formulation of rebif is not approved and under investigation in the US
|
Betaseron
|
|---|---|---|
|
Comparative Phase
STARTED
|
65
|
64
|
|
Comparative Phase
COMPLETED
|
56
|
63
|
|
Comparative Phase
NOT COMPLETED
|
9
|
1
|
|
Extension Phase
STARTED
|
56
|
63
|
|
Extension Phase
COMPLETED
|
35
|
34
|
|
Extension Phase
NOT COMPLETED
|
21
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RNF and Betaseron® Tolerability Study
Baseline characteristics by cohort
| Measure |
New Formulation of Rebif
n=65 Participants
Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
|
Betaseron
n=64 Participants
Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
40.26 years
STANDARD_DEVIATION 9.80 • n=5 Participants
|
40.78 years
STANDARD_DEVIATION 9.56 • n=7 Participants
|
40.52 years
STANDARD_DEVIATION 9.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
64 participants
n=7 Participants
|
129 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From pre-injection to 30 minutes post injection of the VAS pain scores across the first 21 injections of full dose therapy of a new formulation of rebif and BetaseronPopulation: One subject from the new formulation of rebif group discontinued due to pregnancy therefore, data for the Full Dose Calculation 30min Mean Change was not calculated
Subject reported perception of pain on the VAS where the slash drawn by the patient represents pain of increasing intensity from 0 (no pain) to 100 (worse possible pain), measured in millimeters. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 30 minutes post-injection
Outcome measures
| Measure |
New Formulation of Rebif
n=64 Participants
Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
|
Betaseron
n=64 Participants
Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
|
|---|---|---|
|
Visual Analog Scale (VAS) of Patient Reported Pain: Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 30 Minutes Post-injection Timepoints
Mean Pre-Injection VAS Score
|
0.43 mm
Full Range 2.06 • Interval 0.0 to 16.29
|
0.40 mm
Full Range 1.64 • Interval 0.0 to 12.42
|
|
Visual Analog Scale (VAS) of Patient Reported Pain: Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 30 Minutes Post-injection Timepoints
Mean VAS at 30 minutes Post-Injection
|
1.10 mm
Full Range 4.24 • Interval 0.0 to 32.9
|
1.54 mm
Full Range 5.19 • Interval 0.0 to 38.32
|
|
Visual Analog Scale (VAS) of Patient Reported Pain: Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 30 Minutes Post-injection Timepoints
Mean Change to 30 Minutes Post-Injection
|
0.67 mm
Full Range 2.32 • Interval -0.43 to 16.62
|
1.14 mm
Full Range 4.81 • Interval -0.33 to 38.05
|
SECONDARY outcome
Timeframe: Pre-Injection to Immediately after InjectionPopulation: One subject from the new formulation of rebif group discontinued due to pregnancy
A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient immediately after injection.
Outcome measures
| Measure |
New Formulation of Rebif
n=64 Participants
Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
|
Betaseron
n=64 Participants
Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
|
|---|---|---|
|
Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and Immediately After Injection Timepoints
|
1.46 millimeters
Full Range 2.93 • Interval -0.53 to 17.62
|
4.63 millimeters
Full Range 10.02 • Interval -0.1 to 54.86
|
SECONDARY outcome
Timeframe: Pre-injection to 10 minutes post-injectionPopulation: One subject from the new formulation of Rebif group discontinued due to pregnancy
A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 10 minutes post injection.
Outcome measures
| Measure |
New Formulation of Rebif
n=64 Participants
Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
|
Betaseron
n=64 Participants
Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
|
|---|---|---|
|
Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 10 Minutes Post-injection Timepoints
|
0.70 Millimeters
Full Range 1.89 • Interval -0.33 to 10.19
|
1.89 Millimeters
Full Range 5.45 • Interval -0.56 to 36.74
|
SECONDARY outcome
Timeframe: 30 minutes post injectionPopulation: One subject from the new formulation of rebif group discontinued due to pregnancy
A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Pain-free was defined as a VAS score of 0 for all 21 full-dose injections for the Intent-to-Treat (ITT) population.
Outcome measures
| Measure |
New Formulation of Rebif
n=64 Participants
Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
|
Betaseron
n=64 Participants
Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
|
|---|---|---|
|
Number of Pain Free Patients at 30 Minutes Post-injection
|
31 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 1-72 hours post injection over the first 12 weeks including the titration periodPopulation: One subject from the new formulation of rebif group discontinued due to pregnancy
Blinded assessment of mean change in diameter of redness (in mm) at an injection site following an injection
Outcome measures
| Measure |
New Formulation of Rebif
n=64 Participants
Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
|
Betaseron
n=64 Participants
Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
|
|---|---|---|
|
Diameter of Injection Site Redness
|
8.28 mm
Standard Deviation 9.51
|
6.87 mm
Standard Deviation 7.67
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-injection and immediately after injectionPopulation: 3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase
A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient immediately after injection.
Outcome measures
| Measure |
New Formulation of Rebif
n=55 Participants
Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
|
Betaseron
n=58 Participants
Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
|
|---|---|---|
|
Secondary Outcome - Extension Phase: Change in Mean (mm) VAS for Pre-injection and Immediately After Injection Timepoints
|
1.67 millimeters
Interval -0.1 to 19.18
|
2.50 millimeters
Interval -0.18 to 40.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-injection and 10 minutes post injectionPopulation: 3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase
Outcome measures
| Measure |
New Formulation of Rebif
n=55 Participants
Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
|
Betaseron
n=58 Participants
Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
|
|---|---|---|
|
Secondary Outcome - Extension Phase: Change in Mean VAS at Pre-injection and 10 Minutes Post Injection
|
0.40 Millimeters
Interval -2.09 to 10.0
|
0.91 Millimeters
Interval -0.15 to 16.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pain free patients at 30 minutes post injectionPopulation: 3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase
Outcome measures
| Measure |
New Formulation of Rebif
n=55 Participants
Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
|
Betaseron
n=58 Participants
Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
|
|---|---|---|
|
Secondary Outcome - Extension Phase: Number of Pain Free Patients at 30 Minutes Post Injection
|
30 Participants
|
36 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 to 72 hours post injectionPopulation: 3 subjects discontinued and withdrew consent from the Betaseron to Rebif New Formulation Group in the Extension Phase
Outcome measures
| Measure |
New Formulation of Rebif
n=55 Participants
Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
|
Betaseron
n=58 Participants
Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
|
|---|---|---|
|
Secondary Outcome - Extension Phase: Diameter in Injection Site Redness
|
10.79 Millimeters
Standard Deviation 13.89
|
7.46 Millimeters
Standard Deviation 10.57
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-injection and 30 minutes post injectionPopulation: 3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase
Outcome measures
| Measure |
New Formulation of Rebif
n=55 Participants
Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
|
Betaseron
n=58 Participants
Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
|
|---|---|---|
|
Primary Outcome - Extension Phase: Visual Analog Scale (VAS) of Patients Reported Pain; Change in Mean VAS at Pre-injection and 30 Minutes Post Injection
|
0.34 Millimeters
Interval -0.55 to 5.36
|
0.42 Millimeters
Interval -1.17 to 9.79
|
Adverse Events
New Formulation of Rebif
Serious events: 4 serious events
Other events: 62 other events
Deaths: 0 deaths
Betaseron
Serious events: 5 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
New Formulation of Rebif
n=65 participants at risk
Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
|
Betaseron
n=64 participants at risk
Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
|
|---|---|---|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
1.5%
1/65 • Number of events 1
|
1.6%
1/64 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Hepatobiliary disorders
Cholelithiasis / gallstones
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
|
Hepatobiliary disorders
Chronic Hepatits
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
Other adverse events
| Measure |
New Formulation of Rebif
n=65 participants at risk
Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
|
Betaseron
n=64 participants at risk
Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Gastrointestinal disorders
Abdominal Distension
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.6%
3/65 • Number of events 4
|
0.00%
0/64
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal PainUpper
|
6.2%
4/65 • Number of events 4
|
3.1%
2/64 • Number of events 2
|
|
Immune system disorders
Anaphylactic Reaction
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Eye disorders
Blepharospasm
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Eye disorders
Blindness
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
|
Eye disorders
Cataract
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Hepatobiliary disorders
Cholelithiasis
|
3.1%
2/65 • Number of events 2
|
1.6%
1/64 • Number of events 1
|
|
Hepatobiliary disorders
Chronic Hepatitis
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Eye disorders
Conjunctivitis
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Gastrointestinal disorders
Constipation
|
3.1%
2/65 • Number of events 2
|
7.8%
5/64 • Number of events 5
|
|
Cardiac disorders
Coronary Artery Disease
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Gastrointestinal disorders
Dental Caries
|
1.5%
1/65 • Number of events 3
|
0.00%
0/64
|
|
Gastrointestinal disorders
Dental Discomfort
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Gastrointestinal disorders
Diarrhoea
|
4.6%
3/65 • Number of events 3
|
10.9%
7/64 • Number of events 9
|
|
Immune system disorders
Drug Hypersensitivity
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Gastrointestinal disorders
Dry Mouth
|
3.1%
2/65 • Number of events 4
|
0.00%
0/64
|
|
Gastrointestinal disorders
Dyspepsia
|
4.6%
3/65 • Number of events 3
|
1.6%
1/64 • Number of events 9
|
|
Ear and labyrinth disorders
Ear Pain
|
1.5%
1/65 • Number of events 1
|
1.6%
1/64 • Number of events 1
|
|
Ear and labyrinth disorders
Eustachian Tube Obstruction
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
|
Eye disorders
Eye Pain
|
1.5%
1/65 • Number of events 1
|
4.7%
3/64 • Number of events 3
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/65
|
3.1%
2/64 • Number of events 2
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/65
|
4.7%
3/64 • Number of events 3
|
|
General disorders
General Disorders and Administration site condition
|
67.7%
44/65 • Number of events 236
|
70.3%
45/64 • Number of events 244
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
|
Eye disorders
Glaucoma
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
|
Eye disorders
Halo Vision
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Immune system disorders
Hypersensitivity
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Endocrine disorders
Hypothyroidism
|
4.6%
3/65 • Number of events 3
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Infections and Infestations
|
58.5%
38/65 • Number of events 98
|
51.6%
33/64 • Number of events 76
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
21.5%
14/65 • Number of events 35
|
15.6%
10/64 • Number of events 23
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
|
Investigations
Investigations
|
43.1%
28/65 • Number of events 58
|
23.4%
15/64 • Number of events 21
|
|
Eye disorders
Iritis
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
|
Blood and lymphatic system disorders
Iron Defficiency Anamia
|
3.1%
2/65 • Number of events 2
|
0.00%
0/64
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.6%
3/65 • Number of events 3
|
0.00%
0/64
|
|
Gastrointestinal disorders
Lip Dry
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
6.2%
4/65 • Number of events 4
|
7.8%
5/64 • Number of events 6
|
|
Ear and labyrinth disorders
Middle Ear Effusion
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
43.1%
28/65 • Number of events 61
|
42.2%
27/64 • Number of events 83
|
|
Gastrointestinal disorders
Nausea
|
13.8%
9/65 • Number of events 22
|
7.8%
5/64 • Number of events 9
|
|
Nervous system disorders
Nervous system disorders
|
44.6%
29/65 • Number of events 150
|
45.3%
29/64 • Number of events 211
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.1%
2/65 • Number of events 2
|
1.6%
1/64 • Number of events 1
|
|
Psychiatric disorders
Phychiatric
|
24.6%
16/65 • Number of events 25
|
39.1%
25/64 • Number of events 36
|
|
Blood and lymphatic system disorders
Platelet Disorder
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Renal and urinary disorders
Renal Disorder
|
7.7%
5/65 • Number of events 5
|
6.2%
4/64 • Number of events 5
|
|
Reproductive system and breast disorders
Reproductive system and breast disorder
|
6.2%
4/65 • Number of events 4
|
6.2%
4/64 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorder
|
21.5%
14/65 • Number of events 26
|
20.3%
13/64 • Number of events 26
|
|
Skin and subcutaneous tissue disorders
Skin disorders
|
16.9%
11/65 • Number of events 16
|
17.2%
11/64 • Number of events 15
|
|
Gastrointestinal disorders
Stomach Discomfort
|
3.1%
2/65 • Number of events 3
|
1.6%
1/64 • Number of events 2
|
|
Cardiac disorders
Tachycardia
|
1.5%
1/65 • Number of events 1
|
1.6%
1/64 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Ear and labyrinth disorders
Tinnitus
|
1.5%
1/65 • Number of events 1
|
4.7%
3/64 • Number of events 4
|
|
Gastrointestinal disorders
Tongue Ulceration
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Tooth Disorder
|
1.5%
1/65 • Number of events 1
|
0.00%
0/64
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/65
|
3.1%
2/64 • Number of events 2
|
|
Vascular disorders
Vascular disorders
|
6.2%
4/65 • Number of events 4
|
4.7%
3/64 • Number of events 14
|
|
Ear and labyrinth disorders
Vertigo
|
6.2%
4/65 • Number of events 4
|
4.7%
3/64 • Number of events 3
|
|
Eye disorders
Vision Blurred
|
0.00%
0/65
|
3.1%
2/64 • Number of events 4
|
|
Eye disorders
Visual Disturbance
|
1.5%
1/65 • Number of events 1
|
3.1%
2/64 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
4/65 • Number of events 6
|
0.00%
0/64
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Neither Institution nor any Principal Investigators shall publish or present any results from such Study to any third parties until: (i) EMD Serono publishes the results from all sites participating in such Study; (ii) Institution receives notification from EMD Serono that publication of the multi-site results is no longer planned; or (iii) twenty-four (24) months following the completion of the multi-site study at all sites, whichever occurs first.
- Publication restrictions are in place
Restriction type: OTHER