Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis

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

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).

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Etoricoxib; Drug: Aceclofenac

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis as Rheumatoid Arthritis

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Etoricoxib; Etoricoxib 60 mg QD	Drug: Etoricoxib; Etoricoxib 60 mg QD Oral; Other Names: Arcoxia
Experimental: Aceclofenac; Aceclofenac 100 mg BID	Drug: Aceclofenac; Aceclofenac 100 mg BID Oral; Other Names: TONEC

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2007
• Primary Completion (Actual): July 31, 2007
• Study Completion (Actual): July 31, 2007

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: etoricoxib aceclofenac efficacy safety Taiwanese
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Etoricoxib; Aceclofenac
• Other Study ID Numbers: CS07005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No