The primary objective of this study was to evaluate the effect of GLPG3970 compared to placebo on the signs and symptoms of Rheumatoid Arthritis (RA) in participants with moderately to severely active RA and an inadequate response to methotrexate (MTX).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
28
Medical Center Teodora
Rousse, Bulgaria
UMHAT Sv. Ivan Rilski EAD
Sofia, Bulgaria
Aversi Clinic Ltd
Tbilisi, Georgia
Consilium Medulla-multiprofile clinic Ltd
Tbilisi, Georgia
Change From Baseline in DAS-28 (CRP) at Week 6
The DAS28 (CRP) is a derived measurement with differential weighting given to each component such as TJC28, SJC28, patient's global assessment of disease activity, and serum CRP level. * TJC28 ranges from 0-28 * SJC28 ranges from 0-28 * High sensitivity C-reactive protein (hsCRP) (in mg/L) * Patient's disease activity VAS (in mm) (ranges from 0 = best to 100 = worst) The DAS28 (CRP) score was calculated using the below formula: DAS28 (CRP) = 0.56 x square root of TJC28 + 0.28 x square root of SJC28 + 0.36 x Ln\[1+CRP(in mg/L)\] + 0.014 x patient's disease activity VAS (in mm) + 0.96. A lower score is considered as better disease activity.
Time frame: Baseline and Week 6
Number of Participants With Treatment Emergent Adverse Events
Treatment-Emergent Adverse Events (TEAE) were defined as * Any adverse event (AE) with an onset date on or after the IP start date and no later than 14 days after last dose of IP, or worsening of any AE on or after the IP start date. * Improvement or no change of any ongoing AEs on or after the IP start date are not considered treatment-emergent. If an AE was ongoing at the time of first IP intake and if there was no change or an improvement in its toxicity grade or its seriousness status, this AE was not considered as treatment-emergent. Serious TEAE was defined as a TEAE that * Resulted in death and was life-threatening; * Required in-patient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly / birth defect; * Was medically significant;
Time frame: From first dose of study drug until end of the study (up to 8 weeks)
Plasma Concentration (Ctrough) of GLPG3970
Ctrough was defined as plasma concentration level at the end of the dosing interval.
Time frame: Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose
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Centrum Medyczne Grunwald
Poznan, Poland
Centrum Badan Klinicznych S.C.
Poznan, Poland
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv, Ukraine
SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU
Vinnytsia, Ukraine
Medical Center Clinic of Modern Rheumatology
Zaporizhzhya, Ukraine