The primary objective of this study is to evaluate the effects of CKD-506 on signs and symptoms of RA in subjects with moderate-to-severe RA who are inadequate responders to methotrexate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
122
Change from baseline in DAS28(CRP) at week 12
Time frame: Baseline and week 12
Response to treatment based on the American College of Rheumatology 20% response criteria (ACR20) at Weeks 2, 4, 8, and 12
Time frame: At weeks 2, 4, 8 and 12
Change from Baseline in DAS28(CRP) at Weeks 2, 4, and 8
Time frame: Baseline and up to week 8
Response to treatment based on the ACR50 criteria at Weeks 2, 4, 8, and 12
Time frame: At weeks 2, 4, 8 and 12
Response to treatment based on the ACR70 criteria at Weeks 2, 4, 8, and 12
Time frame: At weeks 2, 4, 8 and 12
Change from Baseline in ACRn at Weeks 2, 4, 8, and 12
Time frame: Baseline and up to week 12
Change from Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Weeks 4 and 12
Time frame: Baseline and weeks 4, 12
Change from Baseline in the duration of morning stiffness (in minutes and in severity as measured with a visual analog scale [VAS]) at Weeks 2, 4, 8, and 12
Morning stiffness severity was determined by the Patient's Assessment of Severity and Duration of Morning Stiffness questionnaire. Participants rated the severity of morning stiffness on awakening over the past 7 days on a scale from 0 (No morning stiffness) to 10 (Worst possible morning stiffness).
Time frame: Baseline and up to week 12
Change from Baseline in the Short Form-36 item Health Survey (SF-36) at Weeks 4 and 12
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182RA18009 Stie# CZ06
Broumov, Czechia
182RA18009 Stie# CZ03
Olomouc, Czechia
182RA18009 Stie# CZ02
Prague, Czechia
182RA18009 Stie# CZ05
Prague, Czechia
182RA18009 Stie# CZ07
Prague, Czechia
182RA18009 Stie# CZ08
Prague, Czechia
182RA18009 Stie# CZ09
Prague, Czechia
182RA18009 Stie# CZ01
Uherské Hradiště, Czechia
182RA18009 Stie# UA03
Lviv, Georgia
182RA18009 Stie# GE01
Tbilisi, Georgia
...and 28 more locations
The Short Form-36 item Health Survey (SF-36) consists of eight scaled scores; physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. which are the weighted sums of the questions in their section. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Time frame: Baseline and weeks 4, 12
Change from Baseline in the Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, and 12
Time frame: Baseline and up to week 12
Change from Baseline in the Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, and 12
Time frame: Baseline and up to week 12
Response to treatment based on the achievement of Low Disease Activity (LDA) status based on each of the following definitions at Weeks 2, 4, 8,and 12: DAS28(CRP) ≤ 3.2, SDAI ≤ 11.0, CDAI ≤ 10.0 at Weeks 2, 4, 8, and 12
Time frame: At weeks 2, 4, 8 and 12
Response to treatment based on the achievement of remission based on each of the following definitions at Weeks 2, 4, 8, and 12: DAS28(CRP) < 2.6, Boolean parameters, SDAI ≤ 3.3, CDAI ≤ 2.8 at Weeks 2, 4, 8, and 12
Time frame: At weeks 2, 4, 8 and 12
Improvement of physical ability defined as change from Baseline in HAQ-DI ≥ 0.22 at Weeks 2, 4, 8, and 12
Time frame: Baseline and up to week 12