Trial Outcomes & Findings for Open Label, Multicentre Trial to Assess Safety and Efficacy of ITF2357 in Active Systemic Juvenile Idiopathic Arthritis (NCT NCT00570661)
NCT ID: NCT00570661
Last Updated: 2021-05-04
Results Overview
The primary endpoint describes the number of patients who has completed week 12 of treatment with ITF2357, both in the Per protocol (PP) population and in the Intention to treat (ITT) population. ITF2357 hard gelatine capsules were administered orally, in fed conditions, at the cumulative daily dose of 1.5 mg/kg achieved by administration of 0.75 mg/kg at 12-hour interval for 4 weeks initially. The doses of 1.5 mg/kg/day were achieved by administration of an appropriate number of capsules of definite strength. Treatment was further prolonged up to 12 weeks in total if so suggested by the observed benefits and the lack of treatment-limiting toxicity.
COMPLETED
PHASE2
17 participants
At week 12
2021-05-04
Participant Flow
Seventeen patients were screened and enrolled in the study
Patients with SOJIA according to the International League against Rheumatism criteria, established before the age of 16 y and for at least 6 mo before the study entry, having active disease for at least 1 mo while receiving more than 0.2 mg/kg/day prednisolone or equivalent steroid with/without concurrent methotrexate therapy (≥ 10 mg/m2 weekly).
Participant milestones
| Measure |
ITF2357
ITF2357 hard gelatine capsules were administered orally, in fed conditions, at the cumulative daily dose of 1.5 mg/kg achieved by administration of 0.75 mg/kg at 12-hour interval for 4 weeks initially. The doses of 1.5 mg/kg/day were achieved by administration of an appropriate number of capsules of definite strength (dose strengths of 7.5, 10, 12.5, 15, 20 mg and 50 mg).
Treatment was further prolonged up to 12 weeks in total if so suggested by the observed benefits and the lack of treatment-limiting toxicity
ITF2357: ITF2357 orally administered at the cumulative daily dose of 1.5 mg/kg, achieved by administration of different dose strengths identifiable by different colours.
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|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
ITF2357
ITF2357 hard gelatine capsules were administered orally, in fed conditions, at the cumulative daily dose of 1.5 mg/kg achieved by administration of 0.75 mg/kg at 12-hour interval for 4 weeks initially. The doses of 1.5 mg/kg/day were achieved by administration of an appropriate number of capsules of definite strength (dose strengths of 7.5, 10, 12.5, 15, 20 mg and 50 mg).
Treatment was further prolonged up to 12 weeks in total if so suggested by the observed benefits and the lack of treatment-limiting toxicity
ITF2357: ITF2357 orally administered at the cumulative daily dose of 1.5 mg/kg, achieved by administration of different dose strengths identifiable by different colours.
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|---|---|
|
Overall Study
Disease worsening
|
5
|
|
Overall Study
Unmet criterion of sufficient therapeutic response
|
1
|
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Overall Study
Adverse Event
|
1
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Baseline Characteristics
Open Label, Multicentre Trial to Assess Safety and Efficacy of ITF2357 in Active Systemic Juvenile Idiopathic Arthritis
Baseline characteristics by cohort
| Measure |
ITF2357
n=17 Participants
ITF2357 hard gelatine capsules were administered orally, in fed conditions, at the cumulative daily dose of 1.5 mg/kg achieved by administration of 0.75 mg/kg at 12-hour interval for 4 weeks initially. The doses of 1.5 mg/kg/day were achieved by administration of an appropriate number of capsules of definite strength (dose strengths of 7.5, 10, 12.5, 15, 20 mg and 50 mg).
Treatment was further prolonged up to 12 weeks in total if so suggested by the observed benefits and the lack of treatment-limiting toxicity
ITF2357: ITF2357 orally administered at the cumulative daily dose of 1.5 mg/kg, achieved by administration of different dose strengths identifiable by different colours.
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|---|---|
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Age, Categorical
<=18 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Age, Continuous
|
11.18 years
STANDARD_DEVIATION 5.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At week 12Population: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures. Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available.
The primary endpoint describes the number of patients who has completed week 12 of treatment with ITF2357, both in the Per protocol (PP) population and in the Intention to treat (ITT) population. ITF2357 hard gelatine capsules were administered orally, in fed conditions, at the cumulative daily dose of 1.5 mg/kg achieved by administration of 0.75 mg/kg at 12-hour interval for 4 weeks initially. The doses of 1.5 mg/kg/day were achieved by administration of an appropriate number of capsules of definite strength. Treatment was further prolonged up to 12 weeks in total if so suggested by the observed benefits and the lack of treatment-limiting toxicity.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
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|---|---|---|
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Number of Patients Completing Week 12 of Treatment
Completers
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9 Participants
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10 Participants
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Number of Patients Completing Week 12 of Treatment
Non completers
|
0 Participants
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7 Participants
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SECONDARY outcome
Timeframe: At pretreatment visit, at weeks 2, 4, 6, 8, 10 and 12 (End of treatment), 1 month and 3 months follow up (FU1, FU3) in the PP and ITT populations respectively.Population: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures. Intent-To-Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available. Nevertheless, data on Patient Global Assessment were available only on: n=16 at week 4 and FU1, n=14 at week 6, week 12 and FU3, and n=12 at week 8 and week 10. Other data are missing.
Patient/parent global Visual Analogue Scale (VAS) is from 0 to 100. The lower the score, the better the outcome.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
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|---|---|---|
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JIA Outcome Core Set Variables - Patient Global Assessment
Pre-treatment
|
48.00 units on a scale
Standard Deviation 22.50
|
47.71 units on a scale
Standard Deviation 21.45
|
|
JIA Outcome Core Set Variables - Patient Global Assessment
Week 2
|
43.33 units on a scale
Standard Deviation 21.15
|
42.47 units on a scale
Standard Deviation 21.30
|
|
JIA Outcome Core Set Variables - Patient Global Assessment
Week 4
|
21.22 units on a scale
Standard Deviation 14.00
|
28.88 units on a scale
Standard Deviation 22.48
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JIA Outcome Core Set Variables - Patient Global Assessment
Week 6
|
19.11 units on a scale
Standard Deviation 15.00
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22.36 units on a scale
Standard Deviation 18.33
|
|
JIA Outcome Core Set Variables - Patient Global Assessment
Week 8
|
17.22 units on a scale
Standard Deviation 14.59
|
18.00 units on a scale
Standard Deviation 13.99
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JIA Outcome Core Set Variables - Patient Global Assessment
Week 10
|
17.44 units on a scale
Standard Deviation 13.28
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22.33 units on a scale
Standard Deviation 19.58
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JIA Outcome Core Set Variables - Patient Global Assessment
Week 12
|
19.11 units on a scale
Standard Deviation 14.57
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24.21 units on a scale
Standard Deviation 20.89
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JIA Outcome Core Set Variables - Patient Global Assessment
FU1
|
18.11 units on a scale
Standard Deviation 15.53
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26.56 units on a scale
Standard Deviation 18.02
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JIA Outcome Core Set Variables - Patient Global Assessment
FU3
|
15.38 units on a scale
Standard Deviation 15.32
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22.71 units on a scale
Standard Deviation 17.85
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SECONDARY outcome
Timeframe: At pretreatment visit, at weeks 2, 4, 6, 8, 10 and 12 (End of treatment), 1 month and 3 months follow up (FU1, FU3) in the PP and ITT populations respectively.Population: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available. Nevertheless, data on Physician Global Assessment were available only on n=16 at week 4 and FU1, n=15 at FU3, n=14 at week 6 and week 12, n=12 at week 8 and week 10. Other data are missing.
Physician global Visual Analogue Scale (VAS) is from 0 to 100. The lower the score, the better the outcome.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
|
|---|---|---|
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JIA Outcome Core Set Variables - Physician Global Assessment
Pretreatment
|
48.00 units on a scale
Standard Deviation 22.50
|
47.71 units on a scale
Standard Deviation 21.45
|
|
JIA Outcome Core Set Variables - Physician Global Assessment
Week 2
|
43.33 units on a scale
Standard Deviation 21.15
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42.47 units on a scale
Standard Deviation 21.30
|
|
JIA Outcome Core Set Variables - Physician Global Assessment
Week 4
|
21.22 units on a scale
Standard Deviation 14.00
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28.88 units on a scale
Standard Deviation 22.48
|
|
JIA Outcome Core Set Variables - Physician Global Assessment
Week 6
|
19.11 units on a scale
Standard Deviation 15.00
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22.36 units on a scale
Standard Deviation 18.33
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|
JIA Outcome Core Set Variables - Physician Global Assessment
Week 8
|
17.22 units on a scale
Standard Deviation 14.59
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18.00 units on a scale
Standard Deviation 13.99
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JIA Outcome Core Set Variables - Physician Global Assessment
Week 10
|
17.44 units on a scale
Standard Deviation 13.28
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22.33 units on a scale
Standard Deviation 19.58
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JIA Outcome Core Set Variables - Physician Global Assessment
Week 12
|
19.11 units on a scale
Standard Deviation 14.57
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24.21 units on a scale
Standard Deviation 20.89
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JIA Outcome Core Set Variables - Physician Global Assessment
FU1
|
18.11 units on a scale
Standard Deviation 15.53
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26.56 units on a scale
Standard Deviation 18.02
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|
JIA Outcome Core Set Variables - Physician Global Assessment
FU3
|
15.38 units on a scale
Standard Deviation 15.32
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22.71 units on a scale
Standard Deviation 17.85
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SECONDARY outcome
Timeframe: At pretreatment visit, at weeks 2, 4, 6, 8, 10 and 12 (End of treatment), 1 month and 3 months follow up (FU1, FU3) in the PP and ITT populations respectively.Population: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available. Nevertheless, data on N. joints with active arthritis were assessed only on: n=16 at week 4 and FU1, n=15 at FU3, n=14 at week 6 and week 12, n=12 at week 8 and week 10. Other data are missing.
Number of active joints is from 0 to 75. The lower the score, the better the outcome.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
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|---|---|---|
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JIA Outcome Core Set Variables - Number of Joints With Active Arthritis
Pretreatment
|
9.33 units on a scale
Standard Deviation 8.70
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9.82 units on a scale
Standard Deviation 9.11
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JIA Outcome Core Set Variables - Number of Joints With Active Arthritis
Week 2
|
7.11 units on a scale
Standard Deviation 8.62
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8.41 units on a scale
Standard Deviation 9.49
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|
JIA Outcome Core Set Variables - Number of Joints With Active Arthritis
Week 4
|
3.78 units on a scale
Standard Deviation 5.47
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6.38 units on a scale
Standard Deviation 9.26
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JIA Outcome Core Set Variables - Number of Joints With Active Arthritis
Week 6
|
3.44 units on a scale
Standard Deviation 5.29
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3.57 units on a scale
Standard Deviation 4.33
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JIA Outcome Core Set Variables - Number of Joints With Active Arthritis
Week 8
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3.67 units on a scale
Standard Deviation 4.85
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3.42 units on a scale
Standard Deviation 4.29
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JIA Outcome Core Set Variables - Number of Joints With Active Arthritis
Week 10
|
2.89 units on a scale
Standard Deviation 4.54
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2.75 units on a scale
Standard Deviation 4.03
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JIA Outcome Core Set Variables - Number of Joints With Active Arthritis
Week 12
|
3.44 units on a scale
Standard Deviation 4.59
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4.86 units on a scale
Standard Deviation 4.74
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|
JIA Outcome Core Set Variables - Number of Joints With Active Arthritis
FU1
|
3.00 units on a scale
Standard Deviation 4.50
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3.88 units on a scale
Standard Deviation 4.49
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JIA Outcome Core Set Variables - Number of Joints With Active Arthritis
FU3
|
3.33 units on a scale
Standard Deviation 4.58
|
5.00 units on a scale
Standard Deviation 6.05
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SECONDARY outcome
Timeframe: At pretreatment visit, at weeks 2, 4, 6, 8, 10 and 12 (End of treatment), 1 month and 3 months follow up (FU1, FU3) in the PP and ITT populations respectively.Population: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available. Nevertheless, data on N. joints with limitations were available only on: n=16 at week 4 and FU1, n=15 at FU3, n=14 at week 6 and week 12, n=12 at week 8 and week 10. Other data are missing.
Number of joints with limited range of motion is from 0 to 75. The lower the score, the better the outcome.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
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|---|---|---|
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JIA Outcome Core Set Variables - Number of Joints With Limitation
Week 12
|
4.78 units on a scale
Standard Deviation 5.65
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8.79 units on a scale
Standard Deviation 12.27
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JIA Outcome Core Set Variables - Number of Joints With Limitation
Pretreatment
|
10.00 units on a scale
Standard Deviation 9.53
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11.59 units on a scale
Standard Deviation 14.00
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|
JIA Outcome Core Set Variables - Number of Joints With Limitation
Week 2
|
8.56 units on a scale
Standard Deviation 9.76
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10.41 units on a scale
Standard Deviation 14.42
|
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JIA Outcome Core Set Variables - Number of Joints With Limitation
Week 4
|
6.44 units on a scale
Standard Deviation 7.20
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7.44 units on a scale
Standard Deviation 11.56
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|
JIA Outcome Core Set Variables - Number of Joints With Limitation
Week 6
|
5.78 units on a scale
Standard Deviation 7.17
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7.86 units on a scale
Standard Deviation 11.91
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JIA Outcome Core Set Variables - Number of Joints With Limitation
Week 8
|
5.78 units on a scale
Standard Deviation 6.63
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4.67 units on a scale
Standard Deviation 6.08
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JIA Outcome Core Set Variables - Number of Joints With Limitation
Week 10
|
5.22 units on a scale
Standard Deviation 6.32
|
4.42 units on a scale
Standard Deviation 5.65
|
|
JIA Outcome Core Set Variables - Number of Joints With Limitation
FU1
|
5.00 units on a scale
Standard Deviation 5.92
|
7.94 units on a scale
Standard Deviation 12.22
|
|
JIA Outcome Core Set Variables - Number of Joints With Limitation
FU3
|
5.22 units on a scale
Standard Deviation 5.70
|
7.20 units on a scale
Standard Deviation 8.79
|
SECONDARY outcome
Timeframe: At pretreatment visit, at weeks 2, 4, 6, 8, 10 and 12 (End of treatment), 1 month and 3 months follow up (FU1, FU3) in the PP and ITT populations respectively.Population: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available. Nevertheless, data on CHAQ were available only on: n=16 at week 4 and FU1, n=14 at weeks 6, 12 and FU3, n=12 at weeks 8 and 10. Other data are missing.
The Childhood Health Assessment Questionnaire (CHAQ) is from 0 to 3. For each of 8 section (Dressing and care, Getting up, Eating, Walking, Hygiene, Grasping, Catching, Activities) answers patient is getting 0,1,2 or 3 points (no difficulties, some difficulties, much difficulties, unable to do, respectively). The sum of points is then divided by 8 to get score 0 - 3. The lower the score, the better the outcome.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
|
|---|---|---|
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JIA Outcome Core Set Variables - CHAQ
Pretreatment
|
1.55 units on a scale
Standard Deviation 0.54
|
1.75 units on a scale
Standard Deviation 0.74
|
|
JIA Outcome Core Set Variables - CHAQ
Week 2
|
1.13 units on a scale
Standard Deviation 0.57
|
1.39 units on a scale
Standard Deviation 0.87
|
|
JIA Outcome Core Set Variables - CHAQ
Week 4
|
0.93 units on a scale
Standard Deviation 0.55
|
1.23 units on a scale
Standard Deviation 0.88
|
|
JIA Outcome Core Set Variables - CHAQ
Week 6
|
0.75 units on a scale
Standard Deviation 0.56
|
1.02 units on a scale
Standard Deviation 0.82
|
|
JIA Outcome Core Set Variables - CHAQ
Week 8
|
0.58 units on a scale
Standard Deviation 0.50
|
0.85 units on a scale
Standard Deviation 0.82
|
|
JIA Outcome Core Set Variables - CHAQ
Week 10
|
0.55 units on a scale
Standard Deviation 0.50
|
0.85 units on a scale
Standard Deviation 0.87
|
|
JIA Outcome Core Set Variables - CHAQ
Week 12
|
0.58 units on a scale
Standard Deviation 0.41
|
0.95 units on a scale
Standard Deviation 0.82
|
|
JIA Outcome Core Set Variables - CHAQ
FU1
|
0.56 units on a scale
Standard Deviation 0.39
|
1.02 units on a scale
Standard Deviation 0.93
|
|
JIA Outcome Core Set Variables - CHAQ
FU3
|
0.58 units on a scale
Standard Deviation 0.51
|
0.85 units on a scale
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: At pretreatment visit, at weeks 2, 4, 6, 8, 10 and 12 (End of treatment), 1 month and 3 months follow up (FU1, FU3) in the PP and ITT populations respectively.Population: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available. Nevertheless, data on ESR were available only on: n=16 at week 4 and FU1; n=13 at FU3, n=12 at week 8, n=10 at week 6 and n=8 at week 10. Other data are missing.
Measurements of erythrocyte sedimentation rate (ESR) were performed at the local laboratory cooperating with each study site.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
|
|---|---|---|
|
JIA Outcome Core Set Variables - ESR
FU3
|
44.57 mm/hr
Standard Deviation 25.00
|
41.00 mm/hr
Standard Deviation 25.02
|
|
JIA Outcome Core Set Variables - ESR
Pretreatment
|
65.22 mm/hr
Standard Deviation 23.05
|
62.71 mm/hr
Standard Deviation 31.76
|
|
JIA Outcome Core Set Variables - ESR
Week 2
|
53.44 mm/hr
Standard Deviation 26.54
|
59.12 mm/hr
Standard Deviation 30.90
|
|
JIA Outcome Core Set Variables - ESR
Week 4
|
52.67 mm/hr
Standard Deviation 22.66
|
59.50 mm/hr
Standard Deviation 34.71
|
|
JIA Outcome Core Set Variables - ESR
Week 6
|
57.67 mm/hr
Standard Deviation 20.66
|
53.90 mm/hr
Standard Deviation 22.35
|
|
JIA Outcome Core Set Variables - ESR
Week 8
|
49.33 mm/hr
Standard Deviation 33.78
|
49.92 mm/hr
Standard Deviation 31.20
|
|
JIA Outcome Core Set Variables - ESR
Week 10
|
58.33 mm/hr
Standard Deviation 23.40
|
59.25 mm/hr
Standard Deviation 23.35
|
|
JIA Outcome Core Set Variables - ESR
Week 12
|
56.44 mm/hr
Standard Deviation 40.76
|
54.14 mm/hr
Standard Deviation 37.07
|
|
JIA Outcome Core Set Variables - ESR
FU1
|
39.89 mm/hr
Standard Deviation 28.32
|
46.31 mm/hr
Standard Deviation 28.30
|
SECONDARY outcome
Timeframe: At pretreatment visit, at weeks 2, 4, 6, 8, 10 and 12 (End of treatment), 1 month follow-up (FU1) in the PP and ITT populations respectively.Population: Per Protocol (PP) population: all pts who completed the study without any major protocol deviations Intent-To-Treat (ITT) population: all recruited pts who received medication for whom at least one safety or efficacy measurement is available. But, data on the sum of the first 5 variables were available on: n=16 at week 4; n=15 at FU1; n=14 at weeks 6, 12; n=12 at weeks 8, 10. Data on the sum of the last 5 variables were available on: n=14 at weeks 6, 12; n=12 at weeks 8, 10; n=16 at FU1.
Modified Systemic Feature Score (SFS) variables included: * temperature, rash, lymph nodes, liver and spleen size, and clinical evidence of serositis (clinical variables) * ESR, CRP, leukocyte count, haemoglobin, thrombocyte count (laboratory variables). Items in both sets of variables were scored as present (1) or not present (0) based on predefined criteria. SFS data were presented as the sum of the first 5 items and the sum of the last 5 items. Each sum could range from a minimum of 0 to a maximum of 5.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
|
|---|---|---|
|
Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables
Sum of first 5 (clinical) variables - pre-treatment
|
1.33 score on a scale
Standard Deviation 0.71
|
0.94 score on a scale
Standard Deviation 0.75
|
|
Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables
Sum of first 5 (clinical) variables - Week 2
|
0.44 score on a scale
Standard Deviation 0.73
|
0.35 score on a scale
Standard Deviation 0.61
|
|
Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables
Sum of first 5 (clinical) variables - Week 4
|
0.11 score on a scale
Standard Deviation 0.33
|
0.31 score on a scale
Standard Deviation 0.48
|
|
Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables
Sum of first 5 (clinical) variables - Week 6
|
0.11 score on a scale
Standard Deviation 0.33
|
0.14 score on a scale
Standard Deviation 0.36
|
|
Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables
Sum of first 5 (clinical) variables - Week 8
|
0.11 score on a scale
Standard Deviation 0.33
|
0.17 score on a scale
Standard Deviation 0.39
|
|
Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables
Sum of first 5 (clinical) variables - Week 10
|
0.11 score on a scale
Standard Deviation 0.33
|
0.33 score on a scale
Standard Deviation 0.65
|
|
Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables
Sum of first 5 (clinical) variables - Week 12
|
0.22 score on a scale
Standard Deviation 0.44
|
0.29 score on a scale
Standard Deviation 0.47
|
|
Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables
Sum of first 5 (clinical) variables - FU1
|
0.22 score on a scale
Standard Deviation 0.44
|
0.20 score on a scale
Standard Deviation 0.41
|
|
Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables
Sum of last 5 (lab) variables - pretreatment
|
4.33 score on a scale
Standard Deviation 1.00
|
4.24 score on a scale
Standard Deviation 1.15
|
|
Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables
Sum of last 5 (lab) variables - week 2
|
2.44 score on a scale
Standard Deviation 1.42
|
2.65 score on a scale
Standard Deviation 1.17
|
|
Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables
Sum of last 5 (lab) variables - week 4
|
2.11 score on a scale
Standard Deviation 0.93
|
2.25 score on a scale
Standard Deviation 1.18
|
|
Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables
Sum of last 5 (lab) variables - week 6
|
1.56 score on a scale
Standard Deviation 1.33
|
1.93 score on a scale
Standard Deviation 1.21
|
|
Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables
Sum of last 5 (lab) variables - week 8
|
2.00 score on a scale
Standard Deviation 1.66
|
1.92 score on a scale
Standard Deviation 1.44
|
|
Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables
Sum of last 5 (lab) variables - week 10
|
2.00 score on a scale
Standard Deviation 1.58
|
2.08 score on a scale
Standard Deviation 1.38
|
|
Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables
Sum of last 5 (lab) variables - week 12
|
1.89 score on a scale
Standard Deviation 1.45
|
2.07 score on a scale
Standard Deviation 1.27
|
|
Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables
Sum of last 5 (lab) variables - FU1
|
2.22 score on a scale
Standard Deviation 1.92
|
2.56 score on a scale
Standard Deviation 1.67
|
SECONDARY outcome
Timeframe: Pre-treatment, Weeks 4, 8, 12, and 1-month follow upPopulation: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures. Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available. Nevertheless, data on T are available only on: n=16 at week 4; n=15 at FU1; n=14 at week 12; n=12 at week 8. Other data are missing.
SFS variables included: 1. temperature 2. rash 3. lymph nodes 4. liver and spleen size 5. clinical evidence of serositis (pericarditis, pleuritis or peritonitis) 6. ESR 7. CRP 8. leukocyte count 9. haemoglobin 10. thrombocyte count Temperature was scored as present or not present according to the following criterion: body temperature ≥ 37.5 °C at least once a day during at least five consecutive days or presence of typical SOJIA intermittent temperature chart (patients' temperature chart analysis).
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
|
|---|---|---|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Temperature
Temp - Pretreatment - absence
|
4 participants
|
10 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Temperature
Temp - Pretreatment - presence
|
5 participants
|
7 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Temperature
Temp - Week 4 - absence
|
8 participants
|
12 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Temperature
Temp - Week 4 - presence
|
1 participants
|
4 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Temperature
Temp - Week 8 - absence
|
8 participants
|
10 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Temperature
Temp - Week 8 - presence
|
1 participants
|
2 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Temperature
Temp - Week 12 - absence
|
7 participants
|
11 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Temperature
Temp - Week 12 - presence
|
2 participants
|
3 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Temperature
Temp - FU1 - absence
|
7 participants
|
12 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Temperature
Temp - FU1 - presence
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Pre-treatment, Weeks 4, 8, 12, and 1-month follow upPopulation: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures. Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available. Nevertheless, data on this outcome are available only on: n=16 at week 4 and FU1; n=14 at week 12; n=12 at week 8. Other data are missing.
SFS variables included: 1. temperature 2. rash 3. lymph nodes 4. liver and spleen size 5. clinical evidence of serositis (pericarditis, pleuritis or peritonitis) 6. ESR 7. CRP 8. leukocyte count 9. haemoglobin 10. thrombocyte count Typical SOJIA is a salmon pink rash on the trunk during the febrile episodes.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
|
|---|---|---|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Typical SOJIA Rash
Rash - Pretreatment - absence
|
6 participants
|
14 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Typical SOJIA Rash
Rash - Pretreatment - presence
|
3 participants
|
3 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Typical SOJIA Rash
Rash - Week 4 - absence
|
9 participants
|
16 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Typical SOJIA Rash
Rash - Week 4 - presence
|
0 participants
|
0 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Typical SOJIA Rash
Rash - Week 8 - absence
|
9 participants
|
12 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Typical SOJIA Rash
Rash - Week 8 - presence
|
0 participants
|
0 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Typical SOJIA Rash
Rash - Week 12 - absence
|
9 participants
|
14 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Typical SOJIA Rash
Rash - Week 12 - presence
|
0 participants
|
0 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Typical SOJIA Rash
Rash - FU1 - absence
|
9 participants
|
16 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Typical SOJIA Rash
Rash - FU1 - presence
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Pre-treatment, Weeks 4, 8, 12, and 1-month follow upPopulation: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures. Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available. Nevertheless, data on this outcome are available only on: n=16 at week 4 and FU1; n=14 at week 12; n=12 at week 8. Other data are missing.
SFS variables included: 1. temperature 2. rash 3. lymph nodes 4. liver and spleen size 5. clinical evidence of serositis (pericarditis, pleuritis or peritonitis) 6. ESR 7. CRP 8. leukocyte count 9. haemoglobin 10. thrombocyte count Lymphadenopathy was scored as present or not present according to the following criterion: lymph node (nodes) enlargement to 1.5 cm or more, localized anywhere within the body.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
|
|---|---|---|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Lymphadenopathy
Lymphadenopathy - Pretreatment - absence
|
6 participants
|
13 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Lymphadenopathy
Lymphadenopathy - Pretreatment - presence
|
3 participants
|
4 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Lymphadenopathy
Lymphadenopathy - Week 4 - absence
|
9 participants
|
16 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Lymphadenopathy
Lymphadenopathy - Week 4 - presence
|
0 participants
|
0 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Lymphadenopathy
Lymphadenopathy - Week 8 - absence
|
9 participants
|
12 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Lymphadenopathy
Lymphadenopathy - Week 8 - presence
|
0 participants
|
0 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Lymphadenopathy
Lymphadenopathy - Week 12 - absence
|
9 participants
|
14 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Lymphadenopathy
Lymphadenopathy - Week 12 - presence
|
0 participants
|
0 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Lymphadenopathy
Lymphadenopathy - FU1 - absence
|
9 participants
|
16 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Lymphadenopathy
Lymphadenopathy - FU1 - presence
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Pre-treatment, Weeks 4, 8, 12, and 1-month follow upPopulation: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures. Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available. Nevertheless, data on this outcome are available only on: n=16 at week 4 and FU1; n=14 at week 12; n=12 at week 8. Other data are missing.
SFS variables included: 1. temperature 2. rash 3. lymph nodes 4. liver and spleen size 5. clinical evidence of serositis (pericarditis, pleuritis or peritonitis) 6. ESR 7. CRP 8. leukocyte count 9. haemoglobin 10. thrombocyte count Hepatomegaly and/or splenomegaly was scored as present if confirmed by ultrasound evaluation and established after comparison to age standards for organ size.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
|
|---|---|---|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Hepatomegaly and/or Splenomegaly
Hepatomegaly - FU1 - presence
|
0 participants
|
0 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Hepatomegaly and/or Splenomegaly
Hepatomegaly - Pretreatment - absence
|
8 participants
|
16 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Hepatomegaly and/or Splenomegaly
Hepatomegaly - Pretreatment - presence
|
1 participants
|
1 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Hepatomegaly and/or Splenomegaly
Hepatomegaly - Week 4 - absence
|
9 participants
|
16 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Hepatomegaly and/or Splenomegaly
Hepatomegaly - Week 4 - presence
|
0 participants
|
0 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Hepatomegaly and/or Splenomegaly
Hepatomegaly - Week 8 - absence
|
9 participants
|
12 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Hepatomegaly and/or Splenomegaly
Hepatomegaly - Week 8 - presence
|
0 participants
|
0 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Hepatomegaly and/or Splenomegaly
Hepatomegaly - Week 12 - absence
|
9 participants
|
14 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Hepatomegaly and/or Splenomegaly
Hepatomegaly - Week 12 - presence
|
0 participants
|
0 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Hepatomegaly and/or Splenomegaly
Hepatomegaly - FU1 - absence
|
9 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Pre-treatment, Weeks 4, 8, 12, and 1-month follow upPopulation: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures. Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available. Nevertheless, data on this outcome are available only on: n=16 at week 4 and FU1; n=14 at week 12; n=12 at week 8. Other data are missing.
SFS variables included: 1. temperature 2. rash 3. lymph nodes 4. liver and spleen size 5. clinical evidence of serositis (pericarditis, pleuritis or peritonitis) 6. ESR 7. CRP 8. leukocyte count 9. haemoglobin 10. thrombocyte count Serositis (pericarditis, pleuritis or peritonitis) was scored as present if confirmed by ultrasound and/or X-ray exploration or by the presence of typical ECG findings in the case of pericarditis.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
|
|---|---|---|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Serositis
Serositis - Pretreatment - absence
|
9 participants
|
16 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Serositis
Serositis - Pretreatment - presence
|
0 participants
|
1 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Serositis
Serositis - Week 4 - absence
|
9 participants
|
15 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Serositis
Serositis - Week 4 - presence
|
0 participants
|
1 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Serositis
Serositis - Week 8 - absence
|
9 participants
|
12 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Serositis
Serositis - Week 8 - presence
|
0 participants
|
0 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Serositis
Serositis - Week 12 - absence
|
9 participants
|
13 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Serositis
Serositis - Week 12 - presence
|
0 participants
|
1 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Serositis
Serositis - FU1 - absence
|
9 participants
|
16 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Serositis
Serositis - FU1 - presence
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Pre-treatment, Weeks 4, 8, 12, and 1-month follow upPopulation: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures. Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available. Nevertheless, data on this outcome are available only on: n=16 at week 4 and FU1; n=14 at week 12; n=12 at week 8. Other data are missing.
SFS variables included: 1. temperature 2. rash 3. lymph nodes 4. liver and spleen size 5. clinical evidence of serositis (pericarditis, pleuritis or peritonitis) 6. ESR 7. CRP 8. leukocyte count 9. haemoglobin 10. thrombocyte count At the pre-treatment visit ESR was scored as present or not present according to the following criterion: ESR considered as elevated if ≥ 20 mm/h (first hour) At the subsequent visits ESR was scored 0 (Not present) if decreased by at least 30% as compared to pre-treatment value or normalized (\< 20 mm/h); score 1 (Present) if increased or decreased less than 30%.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
|
|---|---|---|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Erythrocyte Sedimentation Rate (ESR)
ESR - Pretreatment - absence
|
0 participants
|
1 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Erythrocyte Sedimentation Rate (ESR)
ESR - Week 4 - absence
|
2 participants
|
5 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Erythrocyte Sedimentation Rate (ESR)
ESR - FU1 - absence
|
4 participants
|
6 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Erythrocyte Sedimentation Rate (ESR)
ESR - Pretreatment - presence
|
9 participants
|
16 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Erythrocyte Sedimentation Rate (ESR)
ESR - Week 4 - presence
|
7 participants
|
11 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Erythrocyte Sedimentation Rate (ESR)
ESR - Week 8 - absence
|
4 participants
|
4 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Erythrocyte Sedimentation Rate (ESR)
ESR - Week 8 - presence
|
5 participants
|
8 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Erythrocyte Sedimentation Rate (ESR)
ESR - Week 12 - absence
|
3 participants
|
5 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Erythrocyte Sedimentation Rate (ESR)
ESR - Week 12 - presence
|
6 participants
|
9 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Erythrocyte Sedimentation Rate (ESR)
ESR - FU1 - presence
|
5 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Pre-treatment, Weeks 4, 8, 12, and 1-month follow upPopulation: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures. Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available. Nevertheless, data on this outcome are available only on: n=16 at week 4 and FU1; n=14 at week 12; n=12 at week 8. Other data are missing.
SFS variables included: 1. temperature 2. rash 3. lymph nodes 4. liver and spleen size 5. clinical evidence of serositis (pericarditis, pleuritis or peritonitis) 6. ESR 7. CRP 8. leukocyte count 9. haemoglobin 10. thrombocyte count At the pre-treatment visit CRP was scored as present or not present according to the following criterion: CRP considered as elevated if ≥ 10 mg/L. At the subsequent visits CRP was scored 0 (Not present) if decreased by at least 30% compared to pre-treatment value or normalized (\< 10 mg/L); score 1 (Present) if increased or decreased less than 30%.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
|
|---|---|---|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - C-reactive Protein (CRP)
CRP - Week 4 - presence
|
4 participants
|
8 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - C-reactive Protein (CRP)
CRP - Week 8 - absence
|
4 participants
|
6 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - C-reactive Protein (CRP)
CRP - Week 8 - presence
|
5 participants
|
6 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - C-reactive Protein (CRP)
CRP - Week 12 - absence
|
5 participants
|
6 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - C-reactive Protein (CRP)
CRP - Week 12 - presence
|
4 participants
|
8 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - C-reactive Protein (CRP)
CRP - FU1 - absence
|
6 participants
|
10 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - C-reactive Protein (CRP)
CRP - FU1 - presence
|
3 participants
|
6 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - C-reactive Protein (CRP)
CRP - Pretreatment - absence
|
0 participants
|
0 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - C-reactive Protein (CRP)
CRP - Pretreatment - presence
|
9 participants
|
17 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - C-reactive Protein (CRP)
CRP - Week 4 - absence
|
5 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Pre-treatment, Weeks 4, 8, 12, and 1-month follow upPopulation: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures. Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available. Nevertheless, data on this outcome are available only on: n=16 at week 4 and FU1; n=14 at week 12; n=12 at week 8. Other data are missing.
SFS variables included: 1. temperature 2. rash 3. lymph nodes 4. liver and spleen size 5. clinical evidence of serositis (pericarditis, pleuritis or peritonitis) 6. ESR 7. CRP 8. leukocyte count 9. haemoglobin 10. thrombocyte count At the pre-treatment visit WBC was scored as present or not present according to the following criterion: Leukocyte count considered as elevated if ≥ 12 x 103/μL. At the subsequent visits WBC was scored 0 (Not present) if decreased by 20% compared to pre-treatment value or normalized (\< 12x103/μL); score 1 (Present) if increased or decreased less than 20%.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
|
|---|---|---|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - White Blood Cell (WBC)
WBC - Pretreatment - absence
|
2 participants
|
4 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - White Blood Cell (WBC)
WBC - Pretreatment - presence
|
7 participants
|
13 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - White Blood Cell (WBC)
WBC - Week 4 - absence
|
6 participants
|
10 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - White Blood Cell (WBC)
WBC - Week 4 - presence
|
3 participants
|
6 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - White Blood Cell (WBC)
WBC - Week 8 - absence
|
7 participants
|
10 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - White Blood Cell (WBC)
WBC - Week 8 - presence
|
2 participants
|
2 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - White Blood Cell (WBC)
WBC - Week 12 - absence
|
7 participants
|
10 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - White Blood Cell (WBC)
WBC - Week 12 - presence
|
2 participants
|
4 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - White Blood Cell (WBC)
WBC - FU1 - absence
|
5 participants
|
6 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - White Blood Cell (WBC)
WBC - FU1 - presence
|
4 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Pre-treatment, Weeks 4, 8, 12, and 1-month follow upPopulation: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures. Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available. Nevertheless, data on this outcome are available only on: n=16 at week 4 and FU1; n=14 at week 12; n=12 at week 8. Other data are missing.
SFS variables included: 1. temperature 2. rash 3. lymph nodes 4. liver and spleen size 5. clinical evidence of serositis (pericarditis, pleuritis or peritonitis) 6. ESR 7. CRP 8. leukocyte count 9. haemoglobin 10. thrombocyte count At the pre-treatment visit Hb was scored as present or not present according to the following criterion: Haemoglobin considered as lowered if below 11g/dL. At the subsequent visits Hb was scored 0 (Not present) if increased by 20% compared to pre-treatment value or normalized (\> 11 g/dL); score 1 (Present) if decreased or increased less than 20%.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
|
|---|---|---|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Haemoglobin (Hb)
Hb - Week 4 - presence
|
5 participants
|
10 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Haemoglobin (Hb)
Hb - FU1 - presence
|
5 participants
|
8 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Haemoglobin (Hb)
Hb - Pretreatment - presence
|
6 participants
|
11 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Haemoglobin (Hb)
Hb - Week 4 - absence
|
4 participants
|
6 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Haemoglobin (Hb)
Hb - Pretreatment - absence
|
3 participants
|
6 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Haemoglobin (Hb)
Hb - Week 8 - absence
|
4 participants
|
6 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Haemoglobin (Hb)
Hb - Week 8 - presence
|
5 participants
|
6 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Haemoglobin (Hb)
Hb - Week 12 - absence
|
4 participants
|
6 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Haemoglobin (Hb)
WBC - Week 12 - presence
|
5 participants
|
8 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Haemoglobin (Hb)
Hb - FU1 - absence
|
4 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Pre-treatment, Weeks 4, 8, 12, and 1-month follow upPopulation: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures. Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available. Nevertheless, data on this outcome are available only on: n=16 at week 4 and FU1; n=14 at week 12; n=12 at week 8. Other data are missing.
SFS variables included: 1. temperature 2. rash 3. lymph nodes 4. liver and spleen size 5. clinical evidence of serositis (pericarditis, pleuritis or peritonitis) 6. ESR 7. CRP 8. leukocyte count 9. haemoglobin 10. thrombocyte count At the pre-treatment visit thrombocyte count was scored as present or not present according to the following criterion: Thrombocyte count considered as increased if ≥ 400x103/μL. At the subsequent visits thrombocyte count was scored 0 (Not present) if decreased by 20% compared to pretreatment value or normalized (\< 400x103/μL); score 1 (Present) if increased or decreased less than 20%.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
|
|---|---|---|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Thrombocytes
Thrombocytes - Week 12 - presence
|
0 participants
|
0 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Thrombocytes
Thrombocytes - Pretreatment - absence
|
1 participants
|
2 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Thrombocytes
Thrombocytes - Pretreatment - presence
|
8 participants
|
15 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Thrombocytes
Thrombocytes - Week 4 - absence
|
9 participants
|
15 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Thrombocytes
Thrombocytes - Week 4 - presence
|
0 participants
|
1 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Thrombocytes
Thrombocytes - Week 8 - absence
|
8 participants
|
11 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Thrombocytes
Thrombocytes - Week 8 - presence
|
1 participants
|
1 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Thrombocytes
Thrombocytes - Week 12 - absence
|
9 participants
|
14 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Thrombocytes
Thrombocytes - FU1 - absence
|
6 participants
|
9 participants
|
|
Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Thrombocytes
Thrombocytes - FU1 - presence
|
3 participants
|
7 participants
|
SECONDARY outcome
Timeframe: At weeks 2, 4, 6, 8, 10 and 12.Population: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures. Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available.
Clinical improvement at week 2, 4, 6, 8, 10 and 12 was evaluated on the basis of JIA30, JIA50 and JIA70 plus SFS (two points decrease in SFS) as per protocol. Patients were considered as improved and with positive therapeutic response if 3 or more JIA Core Set Variables improved by 30% and no more than one worsened by 30%. JIA50 and JIA70 were defined as an improvement of 3 or more JIA Core Set Variables by 50% and 70%, respectively, and no more than 1 worsened by 30%. Additionally two points decrease in Systemic Feature Score were considered as disease improvement.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
|
|---|---|---|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA30 plus SFS - W12 - Clinical improvement
|
8 participants
|
10 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA50 plus SFS - W6 - Absence of clinical improvement
|
1 participants
|
6 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA50 plus SFS - W10 - Clinical improvement
|
8 participants
|
9 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA70 plus SFS - W12 - Clinical improvement
|
8 participants
|
9 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA30 plus SFS - W2 - Clinical improvement
|
7 participants
|
11 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA30 plus SFS - W2 - Absence of clinical improvement
|
2 participants
|
6 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA30 plus SFS - W4 - Clinical improvement
|
8 participants
|
12 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA30 plus SFS - W4 - Absence of clinical improvement
|
1 participants
|
5 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA30 plus SFS - W6 - Clinical improvement
|
8 participants
|
12 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA30 plus SFS - W6 - Absence of clinical improvement
|
1 participants
|
5 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA30 plus SFS - W8 - Clinical improvement
|
8 participants
|
11 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA30 plus SFS - W8 - Absence of clinical improvement
|
1 participants
|
6 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA30 plus SFS - W10 - Clinical improvement
|
8 participants
|
11 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA30 plus SFS - W10 - Absence of clinical improvement
|
1 participants
|
6 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA30 plus SFS - W12 - Absence of clinical improvement
|
1 participants
|
7 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA50 plus SFS - W2 - Clinical improvement
|
7 participants
|
11 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA50 plus SFS - W2 - Absence of clinical improvement
|
2 participants
|
6 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA50 plus SFS - W4 - Clinical improvement
|
8 participants
|
10 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA50 plus SFS - W4 - Absence of clinical improvement
|
1 participants
|
7 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA50 plus SFS - W6 - Clinical improvement
|
8 participants
|
11 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA50 plus SFS - W8 - Clinical improvement
|
8 participants
|
10 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA50 plus SFS - W8 - Absence of clinical improvement
|
1 participants
|
7 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA50 plus SFS - W10 - Absence of clinical improvement
|
1 participants
|
8 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA50 plus SFS - W12 - Clinical improvement
|
8 participants
|
9 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA50 plus SFS - W12 - Absence of clinical improvement
|
1 participants
|
8 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA70 plus SFS - W2 - Clinical improvement
|
6 participants
|
10 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA70 plus SFS - W2 - Absence of clinical improvement
|
3 participants
|
7 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA70 plus SFS - W4 - Clinical improvement
|
8 participants
|
10 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA70 plus SFS - W4 - Absence of clinical improvement
|
1 participants
|
7 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA70 plus SFS - W6 - Clinical improvement
|
8 participants
|
10 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA70 plus SFS - W6 - Absence of clinical improvement
|
1 participants
|
7 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA70 plus SFS - W8 - Clinical improvement
|
8 participants
|
9 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA70 plus SFS - W8 - Absence of clinical improvement
|
1 participants
|
8 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA70 plus SFS - W10 - Clinical improvement
|
8 participants
|
9 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA70 plus SFS - W10 - Absence of clinical improvement
|
1 participants
|
8 participants
|
|
Number of Patients With JIA Plus SFS Clinical Improvement
JIA70 plus SFS - W12 - Absence of clinical improvement
|
1 participants
|
8 participants
|
SECONDARY outcome
Timeframe: At week 4Population: Per Protocol (PP) population: all patients who completed the study without any major deviations from the protocol procedures. Intent-To Treat (ITT) population: all recruited patients who received study medication and for whom at least one safety or efficacy measurement is available.
Therapeutic response at week 4 was considered sufficient by the Investigator if a decrease in Systemic Feature Score of 2 (at least one of the first five variables) and/or JIA30 response (or above: 50 or 70) was obtained.
Outcome measures
| Measure |
ITF2357 - PP Population
n=9 Participants
All patients in the study PP population (N=9) completed 12 weeks of treatment with ITF2357 according to the specifications of the protocol and thus reached the primary end-point of the study.
|
ITF2357 - ITT Population
n=17 Participants
The analysis was repeated on the ITT population: 10 out of the 17 patients in the ITT population completed 12 weeks of treatment and reached the primary end-point of the study.
|
|---|---|---|
|
Number of Patients With Sufficient Therapeutic Response at Week 4 to Continue Treatment
Therapeutic response
|
8 participants
|
11 participants
|
|
Number of Patients With Sufficient Therapeutic Response at Week 4 to Continue Treatment
Absence of therapeutic response
|
1 participants
|
6 participants
|
Adverse Events
IT2357 - Safety Population
Serious adverse events
| Measure |
IT2357 - Safety Population
n=17 participants at risk
Safety population: all recruited patients who received at least one dose of the study medication.
|
|---|---|
|
Infections and infestations
Varicella
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Infections and infestations
Cellulitis
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
Other adverse events
| Measure |
IT2357 - Safety Population
n=17 participants at risk
Safety population: all recruited patients who received at least one dose of the study medication.
|
|---|---|
|
Injury, poisoning and procedural complications
Injury
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Investigations
Electrocardiogram QT prolonged
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
17.6%
3/17 • Number of events 3 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
General disorders
Fatigue
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
General disorders
Pyrexia
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Gastrointestinal disorders
Enteritis
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 6 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 3 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Renal and urinary disorders
Haematuria
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.8%
2/17 • Number of events 3 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
17.6%
3/17 • Number of events 3 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.9%
1/17 • Number of events 3 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Infections and infestations
Influenza
|
11.8%
2/17 • Number of events 2 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Infections and infestations
Otitis media
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Infections and infestations
Otitis media acute
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Infections and infestations
Pharyngitis
|
5.9%
1/17 • Number of events 1 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
|
Infections and infestations
Tonsillitis
|
5.9%
1/17 • Number of events 2 • At weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment) and FU1 and FU3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place