The purpose of this study is to evaluate the safety and how well guselkumab treatment works (efficacy) in participants with psoriatic arthritis (PsA; a chronic, autoimmune form of arthritis that causes joint inflammation) who had inadequate response to standard therapies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Guselkumab will be administered as subcutaneous injection.
Cims Hospital
Ahmedabad, India
RECRUITINGPost Graduate Institute of Medical Education And Research PGIMER
Chandigarh, India
RECRUITINGNumber of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: Up to 32 weeks
Number of Participants With Serious Adverse Events (SAEs)
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Time frame: Up to 32 weeks
Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 20 Response at Week 12
ACR 20 Response is defined as greater than or equal to (\>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=20 percent (%) improvement from baseline in 3 of following 5 assessments: 1) participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter \[mm\], 0 mm=no pain and 100 mm=worst possible pain), 2) participant's global assessment of disease activity by VAS scale range: 0 mm= very well to 100 mm= very poor, 3) physician's global assessment of disease activity using VAS (scale ranges from 0 = no arthritis to 100 = extremely active arthritis), 4) participant's assessment of physical function measured by Health Assessment Questionnaire-disability Index (HAQ-DI). The derived HAQ-DI ranges from 0 indicating no difficulty to 3 indicating inability to perform a task in that area, and 5) C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR).
Time frame: Week 12
Percentage of Participants Who Achieve an ACR 20 Response at Week 24
ACR 20 Response is defined as \>= 20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=20% improvement from baseline in 3 of following 5 assessments: 1) participant's assessment of pain using VAS (0-100 mm, 0 mm=no pain and 100 mm=worst possible pain), 2) participant's global assessment of disease activity by using VAS (scale range: 0 mm= very well to 100 mm= very poor), 3) physician's global assessment of disease activity using VAS (scale ranges from 0 = no arthritis to 100 = extremely active arthritis), 4) participant's assessment of physical function measured by HAQ-DI. The derived HAQ-DI ranges from 0 indicating no difficulty to 3 indicating inability to perform a task in that area, and 5) CRP and ESR.
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Chennai Meenakshi Multispeciality Hospital
Chennai, India
RECRUITINGAll India Institute of Medical Sciences 1
Gorakhpur, India
RECRUITINGESIC Medical College and Hospital
Hyderabad, India
RECRUITINGNizams Institute of Medical Sciences
Hyderabad, India
RECRUITINGP. D. Hinduja National Hospital and Research Center
Mumbai, India
RECRUITINGAll India Institute of Medical Sciences
New Delhi, India
RECRUITINGSir Ganga Ram Hospital
New Delhi, India
RECRUITINGAll India Institute of Medical Sciences
Patna, India
RECRUITING...and 1 more locations
Time frame: Week 24
Change From Baseline in Analytic Marker of Inflammation (CRP Levels) at Weeks 12 and 24
CRP levels that is the analytic markers of inflammation will be assessed.
Time frame: Baseline, Weeks 12 and 24