Rheumatoid Arthritis
Conditions
Keywords
etoricoxib aceclofenac efficacy safety Taiwanese
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.
Interventions
DRUGEtoricoxib
Etoricoxib 60 mg QD Oral
DRUGAceclofenac
Aceclofenac 100 mg BID Oral
Sponsors
Chung Shan Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis as Rheumatoid Arthritis
Exclusion criteria
* 1\. Pregnant or breast-feeding women. 2. Chemotherapy or radiation therapy in cancer patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Patient's global assessment (PGA) | week 0, week 8 | The investigators use PGA 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 |
| Physician's global assessment (PhGA) | week 0, week 8 | The investigators use PhGA to compared the difference between the week 8 and week 0 |
Outcome results
None listed