| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Juvenile idiopathic arthritis |
|
| E.1.1.1 | Medical condition in easily understood language |
| Inflammatory disorder of joints in children |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To evaluate the effect of treatment with celecoxib on systolic blood pressure (SBP) compared to treatment with naproxen in subjects with JIA (oligoarticular, polyarticular arthritis and children with systemic onset disease but inactive systemic features). |
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| E.2.2 | Secondary objectives of the trial |
1. To evaluate the effect of treatment with celecoxib on diastolic blood pressure (DBP) compared to treatment with naproxen in subjects with JIA
2. To evaluate adverse event profile and gastrointestinal (GI) tolerability of treatment with celecoxib versus (vs.) treatment with naproxen in subjects with JIA
3. To evaluate the effect of treatment with celecoxib on Parent’s and Subject’s Global Assessment of Overall Well-Being compared to treatment with naproxen in subjects with JIA
4. To evaluate the effect of celecoxib and naproxen on BP measured by Ambulatory Blood Pressure Monitoring (ABPM) in subjects with JIA.
|
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| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
| Sub-study (Exploratory Analysis) for 24-Hour Ambulatory Blood Pressure Monitoring (24-hours ABPM) in Subjects with JIA |
|
| E.3 | Principal inclusion criteria |
1. Polyarticular (both rheumatoid factor positive and rheumatoid factor negative), oligoarticular and extended oligoarticular JIA for greater than or equal to (>=) 3 months meeting the International League of Associations for Rheumatology (ILAR) criteria for JIA. Subjects with Systemic JIA with active arthritis in at least 1 joint but without active systemic features are eligible. Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis should be excluded.
2. >=2 years of age and less than (<) 18 years of age prior to the Baseline visit.
3. Body weight >=10 kg at the Baseline visit.
4. Candidate for chronic Non-steroidal anti-inflammatory drug (NSAID) therapy in the Investigator’s judgment.
5. Females of childbearing potential (defined as menarche or >=10 years of age, whichever occurs sooner) must agree to use adequate contraception (adequate contraception can include abstinence if the Investigator deems appropriate) and must have a negative urine pregnancy test prior to administration of study medication.
6. Subject’s parent or legal guardian has provided written informed consent document prior to enrollment in this study.
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|
| E.4 | Principal exclusion criteria |
1. Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis types of JIA
2. Active systemic features over the prior 12 weeks in children with systemic JIA.
3. Subjects taking any of the following medications are specifically excluded:
4. Current NSAID or salicylate compounds (must be discontinued more than (>)5 half-lives, or a minimum of 48 hours, whichever is greater, prior to the Baseline Visit).
5. Anticoagulants (eg, warfarin, heparin, low molecular weight heparin);
• Lithium;
• Cyclosporine;
• Tacrolimus (FK 506);
• Antihypertensives;
• Any medication in the investigator judgment which will affect the blood pressure;
6. Any investigational medication within 30 days prior to Screening or subject is scheduled to receive an investigational drug during the course of this study.
7. Initiation of or the change in doses of disease modifying anti-rheumatic drugs
8. (DMARDs) and / or Biologics within 30 days of Screening.
9. Oral or injectable (including intra-articular) corticosteroids administered within
10. 2 weeks of Screening/Baseline. Subjects are allowed to continue intranasal or
11. orally-inhaled corticosteroids provided they have been at a stable dose for at least 30 days prior to Screening/Baseline and the dose is not expected to change during the duration of the study.
12. Known hypersensitivity allergy or hypersensitivity to sulfonamides, COX-2 selective inhibitors (including celecoxib), aspirin or NSAIDS (including naproxen). Subjects who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs must be excluded.
13. Diagnosis of or received treatment for esophageal, gastric, pyloric channel, or
14. duodenal ulceration within 60 days of Screening.
15. Active GI disease (eg, inflammatory bowel disease, Crohn’s disease, ulcerative
16. colitis), a chronic or acute renal or hepatic disorder, a significant coagulation defect, or any condition that in the Investigator’s opinion might preclude the use of an NSAID.
17. AST /glutamic oxaloacetate transaminase (SGOT), ALT/Serum glutamic pyruvate transaminase (SGPT), Creatinine or Blood urea nitrogen (BUN) > 1.5* upper limit of normal (ULN) for age/gender-adjusted normal values as per the central laboratory, or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days prior to Baseline.
18. Hypertension defined as Systolic blood pressure(SBP) and/or Diastolic Blood pressure (DBP) values >= 95th percentile for the subject’s age, gender, and height (according to the Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children Adolescents for 3 measures at the Baseline visit. If the subject’s medical history indicates that the subject is normotensive, the subjects can be rescreened during the 2-week Screening period to determine if the subject is suitable for the study. Subjects currently treated with antihypertensive medication(s) are not eligible for the study.
19. Active malignancy of any type or history of a malignancy. (Subjects with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and who have no evidence of recurrence in the prior 2 years and at the time of Screening are acceptable).
20. Any significant, uncontrolled chronic condition (eg, diabetes, epilepsy, psychiatric disorders), or any other condition which, in the opinion of the Investigator, would contraindicate study participation or confound interpretation of the results.
21. Plans for surgical intervention during the course of the study.
22. Participated previously in this study.Unlikely to be compliant with study procedures, including calm participation inBP assessments.
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|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Change from Baseline to Week 6/Final visit in Systolic Blood Pressure at Week 6/Final visit |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
1) Change from Baseline in SBP at Week 2 and 4
2) Change from Baseline in DBP at Week 2, 4, and 6/Final visit
3) Change from Baseline in Parent's and Subject's Assessment of Overall Well-Being at Week 6/Final visit
4) Number of subjects with >=30% improvement in the Parent’s Global Assessment of Overall Well-Being
5) Systolic and diastolic blood pressure measured by Ambulatory Blood Pressure Monitoring (ABPM)
6) Number of subjects with treatment-emergent adverse events and serious adverse events |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Baseline, Week 2, 4
2) Baseline, Week 2, 4, 6
3) Baseline, Week 2, 4, 6
4) Week 6
5) Baseline, Week 6
6) Baseline up to 28 days after last dose |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| No |
| E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
| Chile |
| Costa Rica |
| Peru |
| Philippines |
| Russian Federation |
| Serbia |
| South Africa |
| Ukraine |
| United States |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial years | 3 |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
| E.8.9.2 | In all countries concerned by the trial days | 8 |
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