Trial · NCT00570661
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| 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. |
| Secondary | Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Lymphadenopathy | 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 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. |
| Secondary | Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Hepatomegaly and/or Splenomegaly | 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 Hepatomegaly and/or splenomegaly was scored as present if confirmed by ultrasound evaluation and established after comparison to age standards for organ size. |
| Secondary | Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Serositis | 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 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. |
| Secondary | Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Erythrocyte Sedimentation Rate (ESR) | 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 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%. |
| Secondary | Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - C-reactive Protein (CRP) | 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 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%. |
| Secondary | Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - White Blood Cell (WBC) | 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 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%. |
| Secondary | Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Haemoglobin (Hb) | 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 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%. |
| Secondary | Number of Patients With Presence or Absence of Each Item for Modified Systemic Feature Score (SFS) - Thrombocytes | 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 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%. |
| Secondary | Number of Patients With JIA Plus SFS Clinical Improvement | At weeks 2, 4, 6, 8, 10 and 12. | 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. |
| Secondary | Number of Patients With Sufficient Therapeutic Response at Week 4 to Continue Treatment | At week 4 | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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