Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Aceclofenac; Drug: Etoricoxib

• Registration Number: NCT04144101
• Lead Sponsor: Chung Shan Medical University

Brief Summary

Comparison of lower dosage etoricoxib (60 mg daily) with aceclofenac (100 mg bid) for their efficacy and safety in the treatment of rheumatoid arthritis (RA).

Detailed Description

This was a single medical center, parallel-group, randomized controlled trial, which conducted for eight weeks. In this study, 40 patients of RA were randomly assigned to two different treatment groups (etoricoxib and aceclofenac), and 20 patients were enrolled for each group. In addition to baseline data collection, objective assessment tools were used to evaluate for efficacy and safety. The primary endpoint was American College of Rheumatology 20% improvement criteria (ACR20) , secondary endpoints were the ACR 50,70, disease activity score 28 (DAS 28), European League Against Rheumatism (EULAR) response criteria, the number of tender and swollen joints, physician's global assessment, patient's global assessment, pain scores, the short form health survey (SF-36) health Questionnaire and etc. In addition, all adverse reactions were recorded and all the results were analyzed in the intention to treat (ITT) manner.

Study Timeline

• Study Start: 2007-03-01
• Primary Completion: 2007-07-31
• Study Completion: 2007-07-31
• Status Verified: 2019-10
• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Last Update Submitted: 2019-10-28
• Study First Posted: 2019-10-30
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Diagnosis as Rheumatoid Arthritis

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Exclusion Criteria

• 1. Pregnant or breast-feeding women. 2. Chemotherapy or radiation therapy in cancer patients

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aceclofenac	Aceclofenac	Aceclofenac 100 mg BID
Etoricoxib	Etoricoxib	Etoricoxib 60 mg QD

Primary Outcome Measures

Name	Time	Method
American College of Rheumatology 20% improvement criteria (ACR20)	week 0, week 8	The investigators use ACR20 to compared the difference between the week 8 and week 0

Secondary Outcome Measures

Name	Time	Method
American College of Rheumatology 50% improvement criteria (ACR50)	week 0, week 8	The investigators use ACR50 to compared the difference between the week 8 and week 0
American College of Rheumatology 70% improvement criteria (ACR70)	week 0, week 8	The investigators use ACR70 to compared the difference between the week 8 and week 0
Disease activity score 28 (DAS28)	week 0, week 8	The investigators use DAS28 to compared the difference between the week 8 and week 0
Physician's global assessment (PhGA)	week 0, week 8	The investigators use PhGA to compared the difference between the week 8 and week 0
Patient's global assessment (PGA)	week 0, week 8	The investigators use PGA to compared the difference between the week 8 and week 0
European League Against Rheumatism (EULAR) response criteria	week 0, week 8	The investigators use EULAR responder rate to compared the difference between the week 8 and week 0
The number of tender and swollen joints	week 0, week 8	The investigators use the number of tender and swollen joints to compared the difference between the week 8 and week 0
Visual Analog Scale for pain (VAS)	week 0, week 8	The investigators use VAS to compared the difference between the week 8 and week 0
Quality of life by SF-36	week 0, week 8	The investigators use SF-36 to compared the difference between the week 8 and week 0