This is a randomized, double-blinded, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tildrakizumab compared to placebo in anti-TNF naïve subjects with active PsA .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
296
one 1 mL injection of study medication
one 1 mL injection of placebo
The proportion of subjects who achieve American College of Rheumatology [ACR20]
the proportion of subjects achieving a 20% reduction from Baseline in response criteria
Time frame: at Week 24
The proportion of subjects achieving American College of Rheumatology [ACR50]
the proportion of subjects achieving a 50% reduction from Baseline in response criteria
Time frame: at Week 24
The proportion of subjects achieving American College of Rheumatology [ACR70]
the proportion of subjects achieving a 70% reduction from Baseline in response criteria
Time frame: at Week 24
The proportion of subjects achieving Psoriasis Area and Severity Index 75 response among subjects with body surface area ≥3% at baseline
Time frame: at Weeks 24
The change from Baseline in the van der Heijde modified total Sharp score
Time frame: Week 24
The change from Baseline in the van der Heijde modified total Sharp score
Time frame: at Week 16
The Change from Baseline in American College of Rheumatology Response Criteria Components Score
Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Assessment of Arthritis Pain (Visual Analog Scale, 0-100), C-reactive protein levels and erythrocyte sedimentation rate levels
Time frame: at Week 24
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Covina, California, United States
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Miami Beach, Florida, United States
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New Port Richey, Florida, United States
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Tamarac, Florida, United States
Sunpharma site no. 05
Springfield, Missouri, United States
Sunpharma site no. 10
Lincoln, Nebraska, United States
Sunpharma site no. 11
Greenville, South Carolina, United States
Sunpharma site no. 09
Lubbock, Texas, United States
Sunpharma site no. 03
San Antonio, Texas, United States
Sunpharma site no. 01
Tomball, Texas, United States
...and 39 more locations
The change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index
Time frame: at Week 24
The change from Baseline in Leeds Enthesitis Index
Time frame: at Week 24
The change from Baseline in Leeds Dactylitis Index
Time frame: at Week 24
The proportion of subjects who achieve a Disease Activity Score-C-reactive protein < 3.2
Time frame: at Week 24
The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)
Time frame: at Week 24
The proportion of subjects with the Change in van der Heijde modified total Sharp score <0 and < 0.5
Time frame: Week 24
The proportion of subjects with active Psoriasis and body surface area ≥3%
Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100
Time frame: at Week 24
The change from Baseline in anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥ 3% (those with involvement of nails)
Physician Global Assessment-Psoriasis and nail psoriasis severity index
Time frame: at Week 24
The proportion of subjects achieving American College of Rheumatology [ACR20, ACR50 and ACR70]
the proportion of subjects achieving a 20/50/70% reduction from Baseline in response criteria
Time frame: at Week 52
The change from Baseline in American College of Rheumatology Response Criteria Components Score
Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Assessment of Arthritis Pain (Visual Analog Scale, 0-100), C-reactive protein levels and erythrocyte sedimentation rate levels
Time frame: at week 52
change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index
Time frame: at Week 52
The change from Baseline in Leeds Enthesitis Index, Leeds Dactylitis Index and Health Assessment Questionnaire Disability Index score
Time frame: at Week 52
The proportion of subjects who achieve a Disease Activity Score(28 [joints]-C-reactive protein) < 3.2
Time frame: at Week 52
The change from Baseline in van der Heijde modified total Sharp score
Time frame: at Week 52
The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)
Time frame: at Week 52
The proportion of subjects with the change in van der Heijde modified total Sharp score <0 and < 0.5
Time frame: at Week 52
In anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥3%, the proportion of subjects with Psoriasis Area and Severity Index 75, Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100
Time frame: at Week 52
In anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥3% those with involvement of nails, the change from Baseline in nail psoriasis severity index
Time frame: at Week 52
In anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥3%, the change from Baseline in Physician Global Assessment-Psoriasis
Time frame: at week 52
Change from baseline in health assessment questionnaire - disability index (HAQ-DI) score
Time frame: at Week 24
The change from Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components
Time frame: measured timepoints
The change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scores
Time frame: at week 24