Trial Outcomes & Findings for Natalizumab Re-Initiation of Dosing (NCT NCT00306592)
NCT ID: NCT00306592
Last Updated: 2017-03-21
Results Overview
AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Treatment-emergent AEs: events in participants who had received at least 1 dose of study drug, regardless of relationship to study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
404 participants
Primary outcome timeframe
Baseline through Week 48
Results posted on
2017-03-21
Participant Flow
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
Participant milestones
| Measure |
Natalizumab Study 101-MS-322 (NCT00306592)
Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
|
Natalizumab Study 101-MS-321 (NCT00297232)
Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 268 weeks. (Week 52 through Week 480 of Study 101-MS-321 (NCT00297232) is considered to be the Long-Term Treatment Period).
|
|---|---|---|
|
Overall Study
STARTED
|
404
|
690
|
|
Overall Study
Completed at 24 Weeks
|
207
|
0
|
|
Overall Study
Completed Between 24 and 48 Weeks
|
85
|
0
|
|
Overall Study
Completed at 48 Weeks
|
81
|
632
|
|
Overall Study
Entered 101-MS-321 Extension Study
|
22
|
0
|
|
Overall Study
COMPLETED
|
373
|
632
|
|
Overall Study
NOT COMPLETED
|
31
|
58
|
Reasons for withdrawal
| Measure |
Natalizumab Study 101-MS-322 (NCT00306592)
Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
|
Natalizumab Study 101-MS-321 (NCT00297232)
Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 268 weeks. (Week 52 through Week 480 of Study 101-MS-321 (NCT00297232) is considered to be the Long-Term Treatment Period).
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
15
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Noncompliance
|
0
|
2
|
|
Overall Study
Persistent Antibodies
|
6
|
3
|
|
Overall Study
Voluntary
|
10
|
6
|
|
Overall Study
Other
|
1
|
2
|
|
Overall Study
48-week Treatment Period Ongoing
|
0
|
20
|
Baseline Characteristics
Natalizumab Re-Initiation of Dosing
Baseline characteristics by cohort
| Measure |
300 mg Natalizumab IV Monthly
n=1094 Participants
All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
|
|---|---|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 8.12 • n=5 Participants
|
|
Age, Customized
≥ 18 to < 20 years
|
0 participants
n=5 Participants
|
|
Age, Customized
≥ 20 to < 30 years
|
98 participants
n=5 Participants
|
|
Age, Customized
≥ 30 to < 40 years
|
347 participants
n=5 Participants
|
|
Age, Customized
≥ 40 to < 50 years
|
454 participants
n=5 Participants
|
|
Age, Customized
≥ 50 to < 59 years
|
195 participants
n=5 Participants
|
|
Age, Customized
>/= 60 years
|
0 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
755 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
339 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 48Population: Participants receiving at least 1 dose of study drug
AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Treatment-emergent AEs: events in participants who had received at least 1 dose of study drug, regardless of relationship to study drug.
Outcome measures
| Measure |
300 mg Natalizumab IV Monthly
n=1094 Participants
All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)
AE related to study drug
|
161 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)
SAE
|
61 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)
Discontinuation of study drug due to AE
|
24 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)
Withdrawal from study due to AE
|
24 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)
AE
|
826 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)
Moderate or severe AE
|
487 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)
Severe AE
|
66 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)
SAE related to study drug
|
5 participants
|
PRIMARY outcome
Timeframe: Baseline through Week 48Population: Participants receiving at least 1 dose of study drug
For purposes of this analysis, the terms 'hypersensitivity' and 'drug hypersensitivity' were categorized by their temporal relationship to study drug infusion (within 2 hours of the start of the infusion), and were considered equivalent. Hypersensitivity reactions are defined as infusion reactions with the following preferred terms: hypersensitivity not otherwise specified (NOS), anaphylactic reaction, anaphylactoid reaction, dermatitis allergic, drug hypersensitivity, urticaria NOS, vasoconstriction, urticaria generalised, hypersensitivity, urticaria.
Outcome measures
| Measure |
300 mg Natalizumab IV Monthly
n=1094 Participants
All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
|
|---|---|
|
Number of Participants With Hypersensitivity-related Adverse Events
|
8 participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 24 (test was repeated after 8 weeks if positive, to confirm persistence)Population: All participants who received at least 1 dose of natalizumab, had a negative baseline antibody result, and had at least 1 antibody result after the first dose.
'Positive with unknown persistence' is defined as a positive result (≥0.5 micrograms/mL) at one timepoint only with no confirmatory re-test available at least 42 days later. 'Transient positive' is defined as a positive at one timepoint but negative upon re-test at least 42 days later. 'Persistent positive' is defined as positive at 2 or more timepoints separated by at least 42 days. The threshold for classifying a sample as 'antibody positive' was set at the lowest level of reactivity that had a measurable impact on drug serum concentrations.
Outcome measures
| Measure |
300 mg Natalizumab IV Monthly
n=1043 Participants
All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
|
|---|---|
|
Number of Participants With Antibodies to Natalizumab
Antibody negative
|
1004 participants
|
|
Number of Participants With Antibodies to Natalizumab
Antibody positive with unknown persistence
|
15 participants
|
|
Number of Participants With Antibodies to Natalizumab
Antibody transient positive
|
8 participants
|
|
Number of Participants With Antibodies to Natalizumab
Antibody persistent positive
|
16 participants
|
Adverse Events
300 mg Natalizumab IV Monthly
Serious events: 61 serious events
Other events: 492 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
300 mg Natalizumab IV Monthly
n=1094 participants at risk
All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
|
|---|---|
|
Nervous system disorders
Multiple sclerosis relapse
|
1.9%
21/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Infections and infestations
Urinary tract infection
|
0.37%
4/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.27%
3/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Immune system disorders
Hypersensitivity
|
0.18%
2/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Infections and infestations
Cellulitis
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Infections and infestations
Gastroenteritis
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Infections and infestations
Herpes zoster
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Infections and infestations
Influenza
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Infections and infestations
Lung infection
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Infections and infestations
Viral meningitis
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Infections and infestations
Pyelonephritis
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Infections and infestations
Staphyloccal infection
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Immune system disorders
Anaphylactic reaction
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Immune system disorders
Anaphylactic shock
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Psychiatric disorders
Psychotic disorder
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Psychiatric disorders
Schizophrenia
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Cardiac disorders
Atrial fibrillation
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Cardiac disorders
Myocardial fibrosis
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Vascular disorders
Deep vein thrombosis
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Gastrointestinal disorders
Small intestine obstruction
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Gastrointestinal disorders
Cholecystitis
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Pregnancy, puerperium and perinatal conditions
Intra-uterine death
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Reproductive system and breast disorders
Ovarian torsion
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
General disorders
Fatigue
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
General disorders
Pyrexia
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.09%
1/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
Other adverse events
| Measure |
300 mg Natalizumab IV Monthly
n=1094 participants at risk
All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
|
|---|---|
|
Nervous system disorders
Multiple sclerosis relapse
|
14.3%
156/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Infections and infestations
Nasopharyngitis
|
12.9%
141/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.9%
119/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Nervous system disorders
Headache
|
8.3%
91/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
Infections and infestations
Urinary tract infection
|
7.8%
85/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
|
General disorders
Fatigue
|
7.4%
81/1094 • SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER