Trial Outcomes & Findings for A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies (NCT NCT02334748)
NCT ID: NCT02334748
Last Updated: 2020-05-19
Results Overview
The objective of this protocol was to collect additional safety data (serious and non serious AEs) and to provide continuous Ilaris® (canakinumab) treatment to patients in France who completed CACZ885G2301E1, CACZ885N2301 or CACZ885G2306 studies.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
31 participants
Primary outcome timeframe
every 4 weeks up to 1 year
Results posted on
2020-05-19
Participant Flow
Participant milestones
| Measure |
Canakinumab
Patients continued same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose was 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may have been adjusted (or interrupted) according to the clinical response and to investigator's judgment.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Canakinumab
Patients continued same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose was 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may have been adjusted (or interrupted) according to the clinical response and to investigator's judgment.
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|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Inclusion in the CACZ8852306 study
|
1
|
|
Overall Study
Patient no longer required study drug
|
2
|
|
Overall Study
Lack of Efficacy
|
4
|
Baseline Characteristics
A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies
Baseline characteristics by cohort
| Measure |
Canakinumab
n=31 Participants
Patients will continue the same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose is 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may be adjusted (or interrupted) according to the clinical response and to investigators judgment.
|
|---|---|
|
Age, Continuous
|
9.7 years
STANDARD_DEVIATION 4.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 4 weeks up to 1 yearPopulation: Safety set: Safety set consisted of all patients who received at least one dose of study drug and had at least one post-treatment safety assessment in the study.
The objective of this protocol was to collect additional safety data (serious and non serious AEs) and to provide continuous Ilaris® (canakinumab) treatment to patients in France who completed CACZ885G2301E1, CACZ885N2301 or CACZ885G2306 studies.
Outcome measures
| Measure |
Canakinumab
n=31 Participants
Patients continued same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose is 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may have been adjusted (or interrupted) according to the clinical response and to investigators judgment.
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|---|---|
|
Number of Participants With Adverse Events
Serious adverse events
|
7 Participants
|
|
Number of Participants With Adverse Events
Treatment emergent adverse events
|
29 Participants
|
PRIMARY outcome
Timeframe: uo to 1 yearPopulation: Safety set
Number of participants who died for any reason during the study
Outcome measures
| Measure |
Canakinumab
n=31 Participants
Patients continued same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose is 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may have been adjusted (or interrupted) according to the clinical response and to investigators judgment.
|
|---|---|
|
All-cause Mortality
|
0 Participants
|
Adverse Events
Canakinumab (ACZ885)
Serious events: 7 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Canakinumab (ACZ885)
n=31 participants at risk
Patients continued the same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose is 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may have been adjusted (or interrupted) according to the clinical response and to investigators judgment.
|
|---|---|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
3.2%
1/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Epstein-Barr virus infection
|
3.2%
1/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Salmonellosis
|
3.2%
1/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
3.2%
1/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Injury, poisoning and procedural complications
Scar
|
3.2%
1/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
3.2%
1/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Psychiatric disorders
Hallucination, auditory
|
3.2%
1/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Psychiatric disorders
Suicide attempt
|
3.2%
1/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.2%
1/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
Other adverse events
| Measure |
Canakinumab (ACZ885)
n=31 participants at risk
Patients continued the same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose is 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may have been adjusted (or interrupted) according to the clinical response and to investigators judgment.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
9.7%
3/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
19.4%
6/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
12.9%
4/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Gastrointestinal disorders
Nausea
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Gastrointestinal disorders
Toothache
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
General disorders
Asthenia
|
9.7%
3/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
General disorders
Pyrexia
|
22.6%
7/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Bronchitis
|
9.7%
3/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Conjunctivitis
|
12.9%
4/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Gastroenteritis
|
22.6%
7/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Influenza
|
12.9%
4/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Labyrinthitis
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Molluscum contagiosum
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Nasopharyngitis
|
35.5%
11/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Onychomycosis
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Oral herpes
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Paronychia
|
12.9%
4/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Pharyngitis
|
12.9%
4/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Rhinitis
|
12.9%
4/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Sinusitis
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Tonsillitis
|
12.9%
4/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Tracheitis
|
12.9%
4/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Infections and infestations
Viral infection
|
12.9%
4/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Injury, poisoning and procedural complications
Limb injury
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Metabolism and nutrition disorders
Iron deficiency
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
29.0%
9/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.7%
3/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
9.7%
3/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.9%
4/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Nervous system disorders
Headache
|
12.9%
4/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.7%
3/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Skin and subcutaneous tissue disorders
Eczema
|
12.9%
4/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
2/31 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER