Trial · NCT00570661
Open Label, Multicentre Trial to Assess Safety and Efficacy of ITF2357 in Active Systemic Juvenile Idiopathic Arthritis
NCT00570661, Phase 2, Completed, Italfarmaco; results first posted 2021-05-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open Label, Multicentre Trial to Assess Safety and Efficacy of ITF2357 in Active Systemic Juvenile Idiopathic Arthritis. Trials, record NCT00570661. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00570661
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label, Multicentre Trial to Assess Safety and Efficacy of ITF2357 in Active Systemic Juvenile Idiopathic Arthritis
- NCT number
- NCT00570661
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Italfarmaco
- Conditions
- Active Systemic, Onset Juvenile Idiopathic Arthritis
- Interventions
- ITF2357
- First posted
- 2007-12-11
- Last updated
- 2021-05-04
- Results first posted
- 2021-05-04
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Completing Week 12 of Treatment | At week 12 | 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. |
| Secondary | JIA Outcome Core Set Variables - Patient Global Assessment | 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. | Patient/parent global Visual Analogue Scale (VAS) is from 0 to 100. The lower the score, the better the outcome. |
| Secondary | JIA Outcome Core Set Variables - Physician Global Assessment | 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. | Physician global Visual Analogue Scale (VAS) is from 0 to 100. The lower the score, the better the outcome. |
| Secondary | JIA Outcome Core Set Variables - Number of Joints With Active Arthritis | 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. | Number of active joints is from 0 to 75. The lower the score, the better the outcome. |
| Secondary | JIA Outcome Core Set Variables - Number of Joints With Limitation | 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. | Number of joints with limited range of motion is from 0 to 75. The lower the score, the better the outcome. |
| Secondary | JIA Outcome Core Set Variables - CHAQ | 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. | 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. |
| Secondary | JIA Outcome Core Set Variables - ESR | 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. | Measurements of erythrocyte sedimentation rate (ESR) were performed at the local laboratory cooperating with each study site. |
| Secondary | Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables | 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. | 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. |
| Secondary | Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Temperature | Pre-treatment, Weeks 4, 8, 12, and 1-month follow up | 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). |
| Secondary | Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Typical SOJIA Rash | Pre-treatment, Weeks 4, 8, 12, and 1-month follow up | 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Completing Week 12 of Treatment | At week 12 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | JIA Outcome Core Set Variables - Patient Global Assessment | 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. | 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. | units on a scale | MEAN |
| SECONDARY | JIA Outcome Core Set Variables - Physician Global Assessment | 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. | 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. | units on a scale | MEAN |
| SECONDARY | JIA Outcome Core Set Variables - Number of Joints With Active Arthritis | 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. | 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. | units on a scale | MEAN |
| SECONDARY | JIA Outcome Core Set Variables - Number of Joints With Limitation | 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. | 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. | units on a scale | MEAN |
| SECONDARY | JIA Outcome Core Set Variables - CHAQ | 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. | 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. | units on a scale | MEAN |
| SECONDARY | JIA Outcome Core Set Variables - ESR | 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. | 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. | mm/hr | MEAN |
| SECONDARY | Overall SFS Results - Sum of First Five Variables and Sum of Last Five Variables | 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. | 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. | score on a scale | MEAN |
| SECONDARY | Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Temperature | Pre-treatment, Weeks 4, 8, 12, and 1-month follow up | 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. | participants | NUMBER |
| SECONDARY | Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Typical SOJIA Rash | Pre-treatment, Weeks 4, 8, 12, and 1-month follow up | 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. | participants | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group420
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Completing Week 12 of Treatment | ITF2357 - PP Population | Completers | 9 | Participants | |
| Number of Patients Completing Week 12 of Treatment | ITF2357 - ITT Population | Completers | 10 | Participants | |
| Number of Patients Completing Week 12 of Treatment | ITF2357 - PP Population | Non completers | 0 | Participants | |
| Number of Patients Completing Week 12 of Treatment | ITF2357 - ITT Population | Non completers | 7 | Participants | |
| JIA Outcome Core Set Variables - Patient Global Assessment | ITF2357 - PP Population | Pre-treatment | 48.00 | Standard Deviation 22.50 | units on a scale |
| JIA Outcome Core Set Variables - Patient Global Assessment | ITF2357 - ITT Population | Pre-treatment | 47.71 | Standard Deviation 21.45 | units on a scale |
| JIA Outcome Core Set Variables - Patient Global Assessment | ITF2357 - PP Population | Week 2 | 43.33 | Standard Deviation 21.15 | units on a scale |
| JIA Outcome Core Set Variables - Patient Global Assessment | ITF2357 - ITT Population | Week 2 | 42.47 | Standard Deviation 21.30 | units on a scale |
| JIA Outcome Core Set Variables - Patient Global Assessment | ITF2357 - PP Population | Week 4 | 21.22 | Standard Deviation 14.00 | units on a scale |
| JIA Outcome Core Set Variables - Patient Global Assessment | ITF2357 - ITT Population | Week 4 | 28.88 | Standard Deviation 22.48 | units on a scale |
1 to 10 of 420Source ClinicalTrials.gov
See all 420 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ITF2357 | 17 | |
| Overall Study | COMPLETED | ITF2357 | 10 | |
| Overall Study | NOT COMPLETED | ITF2357 | 7 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injury | Injury, poisoning and procedural complications | IT2357 - Safety Population | 1 | 17 | 1 |
| other | Electrocardiogram QT prolonged | Investigations | IT2357 - Safety Population | 1 | 17 | 1 |
| other | Atelectasis | Respiratory, thoracic and mediastinal disorders | IT2357 - Safety Population | 1 | 17 | 1 |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | IT2357 - Safety Population | 3 | 17 | 3 |
| other | Fatigue | General disorders | IT2357 - Safety Population | 1 | 17 | 1 |
| other | Pyrexia | General disorders | IT2357 - Safety Population | 1 | 17 | 1 |
| other | Depression | Psychiatric disorders | IT2357 - Safety Population | 1 | 17 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | IT2357 - Safety Population | 1 | 17 | 1 |
| other | Enteritis | Gastrointestinal disorders | IT2357 - Safety Population | 1 | 17 | 1 |
| other | Nausea | Gastrointestinal disorders | IT2357 - Safety Population | 1 | 17 | 6 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IT2357 - Safety Population | 0 | 17 |
| Total, other adverse events | IT2357 - Safety Population | 14 | 17 |
| Total, serious adverse events | IT2357 - Safety Population | 2 | 17 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00570661
GET https://conductscience.org/api/trials/v1/NCT00570661/results?page=2