The purpose of this study is to compare the efficacy of Biologics + Methotrexate with Biologics + Tacrolimus measured by the disease activity score 28 (DAS28) erythrocyte sedimentation rate (ESR) and the American College of Rheumatology (ACR) scores. The study will also assess the safety of the combinations.
This study will include 4-weeks screening and a 12-week open-label treatment period.The participants in this study will visit the center five (5) times over the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Administered orally
Administered orally
Administered as subcutaneous injection
Site KR82003
Daegu, South Korea
Site KR82007
Daegu, South Korea
Site KR82006
Daejeon, South Korea
Site KR82002
Incheon, South Korea
Change in disease activity score 28 (DAS28) erythrocyte sedimentation rate score (ESR) score at 12 weeks
DAS28-ESR will be calculated using data from tender joint count (TJC) (28 joints), swollen joint count (SJC) (28 joints), ESR and Subject's Global Assessment of Arthritis (SGA) with the formula; DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x SGA. High disease activity: DAS28 score exceeding 5.1 Moderate disease activity: DAS28 score of exceeding 3.2 to 5.1 Low disease activity: DAS28 score of less than or equal to 3.2 If the DAS28 score is less than 2.6, the participant will be considered to be in DAS28 remission.
Time frame: From baseline (week 1) to week 12
Disease activity score 28 (DAS28) erythrocyte sedimentation rate (ESR) rate score at 4 weeks
DAS28-ESR will be calculated using data from TJC (28 joints), SJC (28 joints), ESR and SGA with the formula; DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x SGA. High disease activity: DAS28 score exceeding 5.1 Moderate disease activity: DAS28 score of exceeding 3.2 to 5.1 Low disease activity: DAS28 score of less than or equal to 3.2 If the DAS28 score is less than 2.6, the participant will be considered to be in DAS28 remission.
Time frame: At 4 weeks
DAS28 (ESR) score at 8 weeks
DAS28-ESR will be calculated using data from TJC (28 joints), SJC (28 joints), ESR and SGA with the formula; DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x SGA. High disease activity: DAS28 score exceeding 5.1 Moderate disease activity: DAS28 score of exceeding 3.2 to 5.1 Low disease activity: DAS28 score of less than or equal to 3.2 If the DAS28 score is less than 2.6, the participant will be considered to be in DAS28 remission.
Time frame: At 8 weeks
DAS28 (ESR) score at 12 weeks
DAS28-ESR will be calculated using data from TJC (28 joints), SJC (28 joints), ESR and SGA with the formula; DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x SGA. High disease activity: DAS28 score exceeding 5.1 Moderate disease activity: DAS28 score of exceeding 3.2 to 5.1 Low disease activity: DAS28 score of less than or equal to 3.2 If the DAS28 score is less than 2.6, the participant will be considered to be in DAS28 remission.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Administered by intravenous injection
Administered by intravenous injection
Site KR82009
Seongnam, South Korea
Site KR82001
Seoul, South Korea
Site KR82005
Seoul, South Korea
Site KR82010
Seoul, South Korea
Site KR82012
Seoul, South Korea
Site KR82013
Suwon, South Korea
Time frame: At 12 weeks
Change in DAS28 (ESR) score at 4 weeks
DAS28-ESR will be calculated using data from TJC (28 joints), SJC (28 joints), ESR and SGA with the formula; DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x SGA. High disease activity: DAS28 score exceeding 5.1 Moderate disease activity: DAS28 score of exceeding 3.2 to 5.1 Low disease activity: DAS28 score of less than or equal to 3.2 If the DAS28 score is less than 2.6, the participant will be considered to be in DAS28 remission.
Time frame: From baseline (week 1) to week 4
Change in DAS28 (ESR) score at 8 weeks
DAS28-ESR will be calculated using data from TJC (28 joints), SJC (28 joints), ESR and SGA with the formula; DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x SGA. High disease activity: DAS28 score exceeding 5.1 Moderate disease activity: DAS28 score of exceeding 3.2 to 5.1 Low disease activity: DAS28 score of less than or equal to 3.2 If the DAS28 score is less than 2.6, the participant will be considered to be in DAS28 remission.
Time frame: From baseline (week 1) to week 8
ACR 20 response rate
Percent of participants with American College of Rheumatology (ACR) 20 response rate The ACR20 response requires that all criteria from (1) to (3) be met compared with Week 0 (baseline); (1), Tender Joint Count (TJC) \>= 20% reduction; (2), Swollen Joint Count (SJC) \>= 20% reduction;(3) \>= 20% improvement in three or more of the following five parameters - \[1\] subject's assessment of pain, \[2\] Subject's Global Assessment of Arthritis (SGA), \[3\] Physician's Global Assessment of Arthritis (PGA), \[4\] health assessment questionnaire-disability index (HAQ-DI), \[5\] acute phase reactant (erythrocyte sedimentation rate (ESR)).
Time frame: At 12 weeks
ACR50 response rate
Percent of participants with ACR50 response rate The ACR50 response indicates a 50% improvement in all criteria used in the ACR20 assessment.
Time frame: At 12 weeks
ACR70 response rate
Percent of participants with ACR70 response rate The ACR70 response indicates a 70% improvement in all criteria used in the ACR70 assessment.
Time frame: At 12 weeks
Safety assessed by Adverse Events (AEs)
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Time frame: Up to 16 weeks
Safety assessed by incidence of serious adverse events (SAE)
Adverse Event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
Time frame: Up to 16 weeks
Safety assessed by incidence of treatment emergent adverse events (TEAE)
Treatment Emergent Adverse Event (TEAE) is defined as any AE which starts, or worsens, after the first dose of study drug through 30 days after the last dose of study drug.
Time frame: Up to 12 weeks
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to 16 weeks
Number of participants with vital sign abnormalities and /or adverse events (AEs)
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to 16 weeks
Number of participants with physical exam abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant physical exam values.
Time frame: Up to 16 weeks