NCT04144101

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_4 rheumatoid-arthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2007

Completed
12.3 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

October 28, 2019

Last Update Submit

October 28, 2019

Conditions

Rheumatoid Arthritis

Keywords

etoricoxib aceclofenac efficacy safety Taiwanese

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • American College of Rheumatology 50% improvement criteria (ACR50)

    week 0, week 8

  • American College of Rheumatology 70% improvement criteria (ACR70)

    week 0, week 8

  • Disease activity score 28 (DAS28)

    week 0, week 8

  • European League Against Rheumatism (EULAR) response criteria

    week 0, week 8

  • The number of tender and swollen joints

    week 0, week 8

  • +4 more secondary outcomes

Study Arms (2)

Etoricoxib

EXPERIMENTAL

Etoricoxib 60 mg QD

Drug: Etoricoxib

Aceclofenac

EXPERIMENTAL

Aceclofenac 100 mg BID

Drug: Aceclofenac

Interventions

EtoricoxibDRUG

Etoricoxib 60 mg QD Oral

Also known as: Arcoxia
Etoricoxib
AceclofenacDRUG

Aceclofenac 100 mg BID Oral

Also known as: TONEC
Aceclofenac

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis as Rheumatoid Arthritis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etoricoxibaceclofenac

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Cheng Ching Wei, Ph. D.

    Chung Shan Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 30, 2019

Study Start

March 1, 2007

Primary Completion

July 31, 2007

Study Completion

July 31, 2007

Last Updated

October 30, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share