Trial Outcomes & Findings for A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS) (NCT NCT00642902)
NCT ID: NCT00642902
Last Updated: 2016-05-24
Results Overview
Analysis of T1 Gd-enhancing lesions was done using magnetic resonance imaging (MRI) scans. Only post-baseline scans were included in the calculation of this endpoint (excluding the Study Day 1 scan which had been conducted before first dosing).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
255 participants
Primary outcome timeframe
Weeks 12 to 36
Results posted on
2016-05-24
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
|
Atacicept 25 mg
Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
|
Atacicept 75 mg
Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
|
Atacicept 150 mg
Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
63
|
63
|
64
|
65
|
|
Overall Study
Treated
|
63
|
63
|
63
|
65
|
|
Overall Study
COMPLETED
|
23
|
21
|
21
|
25
|
|
Overall Study
NOT COMPLETED
|
40
|
42
|
43
|
40
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
|
Atacicept 25 mg
Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
|
Atacicept 75 mg
Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
|
Atacicept 150 mg
Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
3
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Premature termination of clinical trial
|
37
|
32
|
35
|
35
|
|
Overall Study
Randomized, but not treated
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
1
|
5
|
1
|
4
|
Baseline Characteristics
A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)
Baseline characteristics by cohort
| Measure |
Placebo
n=63 Participants
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
|
Atacicept 25 mg
n=63 Participants
Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
|
Atacicept 75 mg
n=64 Participants
Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
|
Atacicept 150 mg
n=65 Participants
Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
38.0 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
37.7 years
STANDARD_DEVIATION 9.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
169 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Weeks 12 to 36Population: ITT population included all randomized participants.
Analysis of T1 Gd-enhancing lesions was done using magnetic resonance imaging (MRI) scans. Only post-baseline scans were included in the calculation of this endpoint (excluding the Study Day 1 scan which had been conducted before first dosing).
Outcome measures
| Measure |
Placebo
n=63 Participants
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
|
Atacicept 25 mg
n=63 Participants
Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
|
Atacicept 75 mg
n=64 Participants
Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
|
Atacicept 150 mg
n=65 Participants
Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
|
|---|---|---|---|---|
|
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan
|
3.07 lesions/participant/scan
Interval 1.4 to 6.77
|
2.26 lesions/participant/scan
Interval 0.97 to 5.27
|
2.30 lesions/participant/scan
Interval 1.08 to 4.92
|
2.49 lesions/participant/scan
Interval 1.18 to 5.27
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 36Population: ITT population included all randomized participants. 'n' signifies participants who were evaluable for this measure at given time points for each group, respectively.
Analysis of new T1 Gd-enhancing lesions was done using MRI scans.
Outcome measures
| Measure |
Placebo
n=63 Participants
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
|
Atacicept 25 mg
n=63 Participants
Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
|
Atacicept 75 mg
n=64 Participants
Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
|
Atacicept 150 mg
n=65 Participants
Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
|
|---|---|---|---|---|
|
Number of New T1 Gd-enhancing Lesions Per Participant
Week 12 (n=55, 45, 50, 55)
|
2.55 lesions/participant
Standard Deviation 7.95
|
2.71 lesions/participant
Standard Deviation 7.67
|
3.20 lesions/participant
Standard Deviation 6.41
|
2.96 lesions/participant
Standard Deviation 6.58
|
|
Number of New T1 Gd-enhancing Lesions Per Participant
Week 24 (n=41, 34, 37, 41)
|
0.83 lesions/participant
Standard Deviation 1.70
|
1.50 lesions/participant
Standard Deviation 2.79
|
1.54 lesions/participant
Standard Deviation 2.96
|
1.54 lesions/participant
Standard Deviation 2.94
|
|
Number of New T1 Gd-enhancing Lesions Per Participant
Week 36 (n=23, 22, 24, 26)
|
0.43 lesions/participant
Standard Deviation 0.90
|
1.68 lesions/participant
Standard Deviation 5.09
|
1.38 lesions/participant
Standard Deviation 1.93
|
0.54 lesions/participant
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Baseline up to Week 36Population: ITT population included all randomized participants.
A relapse was defined as the fulfillment of all the following criteria: a) neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both i) neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and ii) neurological abnormality lasting for at least 24 hours; b) absence of fever or known infection (fever with temperature \[axillary, orally, or intrauriculary\] greater than (\>) 37.5 degrees Celsius or 99.5 degrees Fahrenheit); and c) objective neurological impairment, correlating with the participant's reported symptoms, defined as either i) increase in at least 1 of the functional systems of the Expanded Disability Status Scale (EDSS), or ii) increase of the total EDSS score. Percentage of participants free from relapses during 36-week treatment period was reported.
Outcome measures
| Measure |
Placebo
n=63 Participants
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
|
Atacicept 25 mg
n=63 Participants
Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
|
Atacicept 75 mg
n=64 Participants
Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
|
Atacicept 150 mg
n=65 Participants
Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Free From Relapses
|
81.0 percentage of participants
|
69.8 percentage of participants
|
71.9 percentage of participants
|
61.5 percentage of participants
|
SECONDARY outcome
Timeframe: From the first dose of study drug administration up to 12 weeks after the last dose of the study drugPopulation: Safety population included all participants who received at least 1 dose of treatment (either active or placebo).
An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug up to 12 weeks after the last dose of the study drug that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAEs included subjects with both non serious and serious TEAEs.
Outcome measures
| Measure |
Placebo
n=63 Participants
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
|
Atacicept 25 mg
n=63 Participants
Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
|
Atacicept 75 mg
n=63 Participants
Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
|
Atacicept 150 mg
n=65 Participants
Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAEs
|
1 participants
|
3 participants
|
3 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs
|
46 participants
|
40 participants
|
39 participants
|
52 participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Atacicept 25 mg
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Atacicept 75 mg
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
Atacicept 150 mg
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=63 participants at risk
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
|
Atacicept 25 mg
n=63 participants at risk
Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
|
Atacicept 75 mg
n=63 participants at risk
Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
|
Atacicept 150 mg
n=65 participants at risk
Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Infections and infestations
Lung abscess
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Infections and infestations
Pyothorax
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Infections and infestations
Pneumonia
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
3.2%
2/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
General disorders
Asthenia
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Investigations
Body temperature decreased
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.5%
1/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
Other adverse events
| Measure |
Placebo
n=63 participants at risk
Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
|
Atacicept 25 mg
n=63 participants at risk
Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
|
Atacicept 75 mg
n=63 participants at risk
Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
|
Atacicept 150 mg
n=65 participants at risk
Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
|
|---|---|---|---|---|
|
General disorders
Injection site reaction
|
12.7%
8/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
30.2%
19/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
38.1%
24/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
49.2%
32/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
General disorders
Fatigue
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
4.8%
3/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
6.2%
4/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
General disorders
Injection site pain
|
3.2%
2/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
3.2%
2/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
6.2%
4/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Infections and infestations
Nasopharyngitis
|
9.5%
6/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
6.3%
4/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
11.1%
7/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
20.0%
13/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Infections and infestations
Urinary tract infection
|
4.8%
3/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
6.3%
4/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
11.1%
7/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
4.6%
3/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
3/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
6.3%
4/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
12.3%
8/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Infections and infestations
Bronchitis
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
3.2%
2/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
7.7%
5/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Infections and infestations
Influenza
|
7.9%
5/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
3.1%
2/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Nervous system disorders
Headache
|
17.5%
11/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
12.7%
8/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
4.8%
3/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
9.2%
6/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.3%
4/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
0.00%
0/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
4.8%
3/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
4.6%
3/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.3%
4/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
4.8%
3/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.5%
1/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
4.8%
3/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
7.7%
5/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
|
Gastrointestinal disorders
Nausea
|
3.2%
2/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
4.8%
3/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
1.6%
1/63 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
6.2%
4/65 • From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to publishing results, Institution and Principal Investigator (PI) must first provide Sponsor with a copy of proposed publication for review at least 30 days prior to submission. If Institution and PI do not agree to modification, they shall so notify Sponsor and postpone submission for additional 60 days to allow Sponsor to seek legal remedies or file patent applications. There is a need for coordinated approach to any publication of results from sites for any multi-site study.
- Publication restrictions are in place
Restriction type: OTHER