Study in Patients With Moderated to Severe Rheumatoid Arthritis Who Have Failed to Combination Therapy of Conventional Disease-modifying Antirheumatic Drugs (cDMARDs) to cDMARD Plus ANti-TNF Versus cDMARDs in Real World

Browse trials for

• Arthritis 3,556
• Arthritis, Rheumatoid 2,883

Keywords

• Joint pain
• Joint stiffness
• Joint redness
• Loss of joint function
• Swollen joints

Study population

Groups and cohorts

• Participants with RA with cDMARD, but no anti-TNF experience

  Male and female participants diagnosed with rheumatoid arthritis (RA), who have no experience with anti-tumor necrosis factor (anti-TNF) and who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months.

Primary outcomes

1. Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6

   DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.

   Time frame: Baseline; Month 6

Secondary outcomes

1. Change from Baseline in the DAS28-ESR at Month 3

   DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.

   Time frame: Baseline; Month 3

2. Change from Baseline in the DAS28-ESR at Month 12

   DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.

   Time frame: Baseline; Month 12

3. Clinical remission rate measured by DAS28-ESR

   Clinical remission is defined as no tender or swollen joints and a normal erythrocyte sedimentation rate. DAS28 will be used to measure disease activity.

   Time frame: Up to 12 months

4. Success rates of dose-reduction and discontinuation of steroid(s)

   Dose reduction is defined as a reduction by more than 50% compared to baseline.

   Time frame: Up to 12 months

5. Scores on the Korean Health Assessment Questionnaire (KHAQ-20), as a measure of quality of life

   The KHAQ-20 is a participant-assessed measure of health assessment comprised of 8 indices. Scores for each index range from 0 (no difficulty to do) to 3 (unable to do). The total score is a sum of the 8 index score and ranges from 0 to 24. Higher scores indicate more severe disease.

   Time frame: Up to 12 months