DOUBLE BLIND STUDY PARALLEL RANDOMIZED AND ACTIVE COMPARATOR WHOSE PURPOSE IS TO EVALUATE THE SAFETY AND EFFICACY OF CELECOXIB IN SUSPENSION COMPARED WITH NAPROXEN IN SUSPENSION IN PATIENTS WITH YOUNG RHEUMATOID ARTHRITIS.

Not Applicable

• Conditions: -M089; M089

• Registration Number: PER-049-02
• Lead Sponsor: PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-07-22
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. The patient has a diagnosis of JRA of a polyarticular or oligoarticular course determined according to the CAR criteria. Patients with systemic onset JRA who have a polyarticular or oligoarticular course are eligible. Patients with Active systemic characteristics will not be included.
2. The patient is at least two years old and has not yet reached his 17th birthday.
3. The patient must weigh at least 15 kg.
4. The patient must have> 1 swollen joint and> 1 joint with limitation of the movement. Joints with limited range of movements can be the same as the swollen joints.
5. Must have rm CESN score of> 0.2.
6. Must have a global evaluation by the physician and the father in the selection of> 20 mm on a 100 mm EVA scale.

Exclusion Criteria

1. The patient is in the active phase of systemic JRA.
2. The patient has received or has been exposed to investigational drugs within the specified times before receiving the first dose of the medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:1. Overall assessment of the disease activity by the doctor;<br>2. Evaluation by the Father of the overall evaluation of total well-being;<br>3. Functional capacity;<br>4. Number of joints with active arthritis;<br>5. Number of joints with limitation in the range of movements; Y<br>6. Inflammation laboratory marker (C-Reactive Protein will be used in this study).<br>Measure:Improvement in the patients arthritic condition defined according to criterion ARJ 30.<br>Timepoints:week 2, 4, 8, 12<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:1. Adverse events<br>2. Values of laboratory tests<br>3. Measurements of vital signs<br>Measure:Safety evaluation<br>Timepoints:week 2, 4, 8, 12<br>