This is a multicenter Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
508
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: at Week 24
The change from Baseline in the van der Heijde modified total Sharp score
Time frame: at Week 16
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, Erythrocyte sedimentation rate levels
Time frame: at Week 24
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Sunpharma Site no 42
Dothan, Alabama, United States
Sunpharma Site no 29
Gilbert, Arizona, United States
Sunpharma Site no 30
Glendale, Arizona, United States
Sunpharma Site no 31
Mesa, Arizona, United States
Sunpharma Site no 35
Covina, California, United States
Sunpharma Site no 48
Encino, California, United States
Sunpharma site no. 17
Fountain Valley, California, United States
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Thousand Oaks, California, United States
Sunpharma Site no. 141
Avon Park, Florida, United States
Sunpharma site no. 21
Clearwater, Florida, United States
...and 87 more locations
change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index
Time frame: at Week 24
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: at Week 24.
The proportion of subjects with active Psoriasis and Body surface area ≥3%
with: Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100
Time frame: at Week 24
The change from Baseline in 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, Erythrocyte sedimentation rate levels
Time frame: at Week 52
The change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index
Time frame: at Week 52
The change from Baseline
Leeds Enthesitis Index, Leeds Dactylitis Index, 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 subjects with active Psoriasis and Body surface area ≥3%, the proportion of subjects
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 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 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
Physical Functioning Domain, Role-Physical Domain, Role-Emotional Domain, Bodily Pain Domain, Mental Health Domain, General Health Domain, Vitality Domain, Social Functioning Domain, Physical Component Summary Score, Mental Component Summary Score
Time frame: Weeks 24 and 52
The change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scores
Time frame: at Week 24