Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Lower Dosage of Etoricoxib Versus Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis: A Single-center, Parallel-group, Randomized Controlled Pilot Study

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Etoricoxib
* Drug: Aceclofenac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis as Rheumatoid Arthritis Exclusion Criteria: 1. Pregnant or breast-feeding women. 2. Chemotherapy or radiation therapy in cancer patients

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etoricoxib<br>Etoricoxib 60 mg QD | Drug: Etoricoxib<br>* Etoricoxib 60 mg QD Oral<br>* Other names: Arcoxia;|
| Experimental: Aceclofenac<br>Aceclofenac 100 mg BID | Drug: Aceclofenac<br>* Aceclofenac 100 mg BID Oral<br>* Other names: TONEC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American College of Rheumatology 20% improvement criteria (ACR20) | The investigators use ACR20 to compared the difference between the week 8 and week 0 | week 0, week 8 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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etoricoxib aceclofenac efficacy safety Taiwanese