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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| CKD-506 Dose A | Experimental |
| |
| CKD-506 Dose B | Experimental |
| |
| CKD-506 Dose C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-506 | Drug | Tablets for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in DAS28(CRP) at week 12 | Baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Response to treatment based on the American College of Rheumatology 20% response criteria (ACR20) at Weeks 2, 4, 8, and 12 | At weeks 2, 4, 8 and 12 | |
| Change from Baseline in DAS28(CRP) at Weeks 2, 4, and 8 | Baseline and up to week 8 |
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Inclusion Criteria:
Diagnosis of RA for at least 6 months prior to Screening, currently meet the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for RA, and are ACR functional class I-III.
Have active RA
Ongoing treatment with a stable dose of MTX as described below:
Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least 12 weeks after the last dose of study treatment.
Women of childbearing potential must have a negative serum pregnancy test at Screening and urine pregnancy test at Baseline
Sexually active men, if not surgically sterile, must agree to use a medically acceptable form of contraception during the study and continue its use for at least 12 weeks after the last dose of study treatment.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 182RA18009 Stie# CZ06 | Broumov | Czechia | ||||
| 182RA18009 Stie# CZ03 |
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| Placebo | Drug | Tablets for oral administration |
|
| Response to treatment based on the ACR50 criteria at Weeks 2, 4, 8, and 12 | At weeks 2, 4, 8 and 12 |
| Response to treatment based on the ACR70 criteria at Weeks 2, 4, 8, and 12 | At weeks 2, 4, 8 and 12 |
| Change from Baseline in ACRn at Weeks 2, 4, 8, and 12 | 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 | 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). | Baseline and up to week 12 |
| Change from Baseline in the Short Form-36 item Health Survey (SF-36) at Weeks 4 and 12 | 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. | Baseline and weeks 4, 12 |
| Change from Baseline in the Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, and 12 | Baseline and up to week 12 |
| Change from Baseline in the Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, and 12 | 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 | 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 | 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 | Baseline and up to week 12 |
| 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 |
| 182RA18009 Stie# GE02 | Tbilisi | Georgia |
| 182RA18009 Stie# GE03 | Tbilisi | Georgia |
| 182RA18009 Stie# PL04 | Bydgoszcz | Poland |
| 182RA18009 Site# PL01 | Elblag | Poland |
| 182RA18009 Stie# PL03 | Grodzisk Mazowiecki | Poland |
| 182RA18009 Stie# PL02 | Katowice | Poland |
| 182RA18009 Stie# PL07 | Lodz | Poland |
| 182RA18009 Stie# PL06 | Poznan | Poland |
| 182RA18009 Stie# PL08 | Poznan | Poland |
| 182RA18009 Stie# PL05 | Skierniewice | Poland |
| 182RA18009 Stie# PL10 | Torun | Poland |
| 182RA18009 Stie# PL09 | Warsaw | Poland |
| 182RA18009 Stie# RF05 | Moscow | Russia |
| 182RA18009 Stie# RF10 | Moscow | Russia |
| 182RA18009 Stie# RF09 | Perm | Russia |
| 182RA18009 Stie# RF03 | Saint Petersburg | Russia |
| 182RA18009 Stie# RF08 | Saint Petersburg | Russia |
| 182RA18009 Stie# RF02 | Tolyatti | Russia |
| 182RA18009 Stie# RF07 | Tver' | Russia |
| 182RA18009 Stie# RF06 | Vladimir | Russia |
| 182RA18009 Stie# UA10 | Ivano-Frankivsk | Ukraine |
| 182RA18009 Stie# UA09 | Kharkiv | Ukraine |
| 182RA18009 Stie# UA01 | Kyiv | Ukraine |
| 182RA18009 Stie# UA04 | Kyiv | Ukraine |
| 182RA18009 Stie# UA07 | Kyiv | Ukraine |
| 182RA18009 Stie# UA11 | Kyiv | Ukraine |
| 182RA18009 Stie# UA05 | Vinnytsia | Ukraine |
| 182RA18009 Stie# UA06 | Vinnytsia | Ukraine |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000720039 | CKD-506 |
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