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The purpose of this clinical trial is to determine the optimal dose of HL237 tablets in rheumatoid arthritis patients by comparing the efficacy and safety of the three dose groups of HL237 tablets and the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | HL237 tab. 200mg/day |
|
| Treatment B | Experimental | HL237 tab. 400mg/day |
|
| Treatment C | Experimental | HL237 tab. 800mg/day |
|
| Placebo | Placebo Comparator | Placebo of HL237 tab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL237 tablet | Drug | Treatment A : HL237 100mg, twice a day, Treatment B : HL237 200mg, twice a day, Treatment C : HL237 400mg, twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| ACR20(american college of rheumatology 20) response rate | ACR20(american college of rheumatology 20) response rate at 12 weeks after administering investigational products | at 12 weeks after administering investigational products |
| Measure | Description | Time Frame |
|---|---|---|
| ACR20(american college of rheumatology 20) response rate | ACR20(american college of rheumatology 20) response rate at 4, 8 weeks after administering investigational products | at 4, 8 weeks after administering investigational products |
| DAS28-ESR(Disease Activity Score 28- erythrocyte sedimentation rate) score |
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Inclusion Criteria:
Male or Female, 19 years ≤ age ≤ 80 years
In the case of women of childbearing age, those who have a negative pregnancy test before randomization
Patients who agree to use a medically accepted method of contraception during the clinical trial
Patients corresponding to ACR functional class â… ,â…¡,â…¢
Patients with active rheumatoid arthritis with DAS28-ESR > 3.2 in the evaluation of DAS28-ESR identified at the screening
Patients who were diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria at least 3 months prior to the screening, and showed insufficient response or refractory to treatment with one or more DMARDs.
Among the subjects who have previously been continuously administering the following rheumatoid arthritis drugs without stopping, those who have used them according to the conditions before randomization and can maintain the current administration regimen and dose during the clinical trial.
Patients who have completed the wash-out period as follows until the 2nd visit including the screening period (each period refers to the case where it continues consecutively, and these drugs are contraindicated from the screening).
Volunteer, be willing and able to provide written informed consent for the trial
Patients who can read and understand written instructions
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea Seoul ST.MARY'S Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Placebo of HL237 tablet | Drug | Placebo of HL237, twice a day |
|
Change of DAS28-ESR(Disease Activity Score 28- erythrocyte sedimentation rate) score |
| at 4, 8, 12 weeks after administering investigational products |
| DAS28-CRP(Disease Activity Score 28-C-reactive protein) score | Change of DAS28-CRP(Disease Activity Score 28-C-reactive protein) score Change of DAS28-ESR(Disease Activity Score 28- erythrocyte sedimentation rate) score | at 4, 8, 12 weeks after administering investigational products |
| Tender joint count | Change of Tender joint count | at 4, 8, 12 weeks after administering investigational products |
| Swollen joint count | Change of Swollen joint count | at 4, 8, 12 weeks after administering investigational products |
| Investigator's composite assessment of disease activity | Change of Investigator's composite assessment of disease activity (100 mm visual analog scale (0: not active at all, 100: most severely active)) | at 4, 8, 12 weeks after administering investigational products |
| Subject's composite assessment of disease activity | Change of Subject's composite assessment of disease activity (100 mm visual analog scale (0: not active at all, 100: most severely active)) | at 4, 8, 12 weeks after administering investigational products |
| Subject's assessment of pain (visual analog scale) | Change of Subject's assessment of pain (100 mm visual analog scale(0: no pain, 100: severe pain)) | at 4, 8, 12 weeks after administering investigational products |
| Subject's assessment of physical function (Korean health assessment questionnaire) | Change of Subject's assessment of physical function (Korean health assessment | at 4, 8, 12 weeks after administering investigational products |
| Erythrocyte Sedimentation Rate (ESR) | Change of Erythrocyte Sedimentation Rate (ESR) | at 4, 8, 12 weeks after administering investigational products |
| C-Reactive Protein (CRP) | Change of C-Reactive Protein (CRP) | at 4, 8, 12 weeks after administering investigational products |
| morning stiffness duration | Change of morning stiffness duration | at 4, 8, 12 weeks after administering investigational products |
| The average number of times of use the remedy per day | Change of The average number of times of use the remedy per day | at 4, 8, 12 weeks after administering investigational products |
| The percentage of subjects who use the remedy | Change of the percentage of subjects who use the remedy | at 4, 8, 12 weeks after administering investigational products |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |