Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis

Chung Shan Medical University

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Aceclofenac; Drug: Etoricoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT04144101

CS07005

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis as Rheumatoid Arthritis

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Etoricoxib

Experimental group

Description:

Etoricoxib 60 mg QD

Treatment:

Drug: Etoricoxib

Aceclofenac

Experimental group

Description:

Aceclofenac 100 mg BID

Treatment:

Drug: Aceclofenac