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A multicenter, open, prospective observational study to confirm the clinical efficacy and safety after drug change in patients with degenerative arthritis (spondyloarthritis, knee arthritis) treated with anti-inflammatory analgesics

Not Applicable
Conditions
Diseases of the musculoskeletal system and connective tissue
Registration Number
KCT0007770
Lead Sponsor
Yonsei University Health System, Severance Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
800
Inclusion Criteria

1) Patients over 20 years of age who have been diagnosed with spondyloarthritis or gonarthritis among degenerative arthritis prescribed non-selective NSAIDs.
2) Patients who have not been given Cox2-selective NSAIDs in the treatment of degenerative arthritis within the last 2 weeks.
3) Patients whose history identifies osteoarthritis with symptoms of the body and whose pain VAS test performed in Visit 2 is greater than 40 mm
4) A person who voluntarily agrees to participate in this study is able to understand the information provided to him or her and can sign a written consent form at will

Exclusion Criteria

1) A person diagnosed with a clinically significant mental illness and receiving medication.
2) Patients who scheduled for surgery during the clinical study.
3) Patients who have a history of allergies to the ingredients that make up this clinical research drug.
4) A person who is deemed to have a life expectancy of less than six months due to malignant tumors or other serious health conditions affecting his/her life;
5) Those who participated in another clinical study within 4 weeks before participating in the study
6) Subjects who are unable to implement the clinical research process specified in the plan
7) Any other person deemed inappropriate to participate in this clinical study due to the medical opinion of the researcher;

Study & Design

Study Type
Observational Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
100mm Pain VAS Variation;EQ-5D-5L Variation
Secondary Outcome Measures
NameTimeMethod
100mm Pain VAS Variation;EQ-5D-5L Variation;ODI change in case of osteoarthritis;K-WOMAC [22] change in case of gonarthritis;Overall drug discontinuation rate;drug discontinuation rate according to Satisfied with pain control;drug discontinuation rate according to AE;drug discontinuation rate according to insufficient effect
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