A 12-WEEK STUDY CONTROLLED WITH AN ACTIVE COMPARATOR AGENT TO EVALUATE THE EFFICACY AND SAFETY OF ROFECOXIB FOR THE TREATMENT OF YOUTH RHEUMATOID ARTHRITIS
- Conditions
- -M080 Juvenile rheumatoid arthritisJuvenile rheumatoid arthritisM080
- Registration Number
- PER-005-01
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Patient from 2 to 17 years old.
• Patient with a diagnosis of polyarticular JRA or pauci (oligo) articular without active systemic symptoms (during the last 3 months) based on the diagnostic criteria mentioned in Appendix 1.
• Patient with a diagnosis of ARJ of at least 3 months.
• At the screening visit (Visit 1.0), the patient / parent assessment of overall well-being (EVA 100 mm) is <90 mm and at the time of allocation (Visit 2.0) it is> 10 mm.
• Patient with at least 3 active joints at the time of the appointment (Visit 2.0).
• Girls of menarche age with a negative pregnancy test on serum P-HCG within 14 days prior to the treatment period. If they are sexually active, girls should use an acceptable contraceptive method (eg, oral contraceptives) from 2 weeks before treatment to 2 weeks after the study ends.
• The parents or guardians and the patient agree that the patient participates in the indicated study program by means of! permission and consent (as appropriate) of the parents respectively. The patient wishes to comply with the study procedures and can attend scheduled clinic visits.
• The patient is considered to be in good health based on the medical history, physical examination and routine laboratory tests
• The patient is not overweight or underweight according to age, being between the 5th to 95th percentile of the weight according to height.
• Patient under 2 years of age or who will turn 18 before the end of the treatment period.
• The patient is, in the opinion of the researcher, mentally incapacitated.
• The patient is in a situation (for example, unreliable nursing care) or suffers from a condition that, in the opinion of the investigator, may interfere with their optimal participation in the study.
• Pregnant or breastfeeding patient or a sexually active child who does not want to use an adequate contraceptive method or remain abstinent during the study.
• Patient in whom all the symptoms and signs of an acute systemic infection have not been resolved at least 2 weeks before the pre-study visit.
• Patient with a history of a clinically significant disease of the gastrointestinal system (eg, active peptic ulcer or inflammatory bowel disease), cardiovascular, hepatic (Child-Pugh score 27), neurological, renal, genitourinary or hematologic or with chronic hypertension .
• Patient with estimated creatinine clearance <30 mL / min.
• Patient who has undergone surgery, donated a blood unit or participated in another clinical study during the last 4 weeks.
• Patient with hypersensitivity (for example, angioedema and / or bronchoconstriction) to acetylisalicylic acid and / or NSAIDs.
• Patient with a specific contraindication to a 12-week course with an NSAID such as naproxen
• Patient with a history of a disease that, in the opinion of the investigator, may confuse the results of the study or pose an additional risk to the patient when administering rofecoxib
• Evaluation of parents / patient of global well-being (EVA)> 90 mm at the screening visit (Visit 1.0) and <10 mm at the time of the assignment (Visit 2.0).
• The patient has less than 3 active joints at the time of assignment (Visit 2.0).
• Patient with extreme or non-conventional dietary habits.
• Unstable use of TNF kidnappers during the last 3 months.
• Alcoholism or drug addiction.
• The routine medication regimen for the patient´s arthritis is unstable.
• Doses of gold, methotrexate, sulfasalazine and antimalarials should have been stable for at least 6 weeks and are expected to remain stable during the study. Doses of corticosteroids (maximum equivalent of 0.2 mg / kg / day of prednisone, should not exceed 10 mg) must have been stable for at least 4 weeks and are expected to remain stable during the study. Any other medication taken for JRA at the time of selection must have been stable for 4 weeks and, except for NSAIDs, including COX 2 inhibitors and salicylates (which can not continue during the study treatment), anticipates that they will remain stable during the study.
• Patient who has received an intra-articular injection with corticosteroid (eg, triamcinolone acetonide) in the last 4 weeks (3 months if the preparation was triamcinolone hexacetonide).
• Another patient´s medical scheme has not been stable (for example, medications have been started or stopped or there have been adjustments in the dose) during the 2 weeks prior to the selection.
• Patient who will use any of the following medications during the study:
o Salicylates, NSAIDs or specific COX 2 inhibitors not belonging to the study during the treatment period. Exception: The use of low doses of acetylisalicylic acid is allowed up to 100 mg per day as antiplatelet therapy.
o Systemic corticosteroids at doses of> 0.2 mg / kg / day of prednisone, without exc
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Evaluation by the Patient or Parents of Global Wellbeing<br>Measure:Global Wellbeing<br>Timepoints:In the pre-study visit and in all subsequent visits.<br>
- Secondary Outcome Measures
Name Time Method