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Efficacy and Safety Study of SUNPG1623

Primary Purpose

Active Psoriatic Arthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SUNPG1623 I
SUNPG1623 II
SUNPG1623 III
SUNPG1623 IV
PLACEBO
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Active Psoriatic Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject has provided written informed consent
  • Subject is ≥ 18 years of age at time of Screening
  • Subject must be on stable dose of NSAID for ≥ 4 weeks prior to initiation of IMP
  • Subject has a negative evaluation for TB within 4 weeks before initiating IMP
  • Subject has a diagnosis of PsA (by the Classification of Psoriatic Arthritis [CASPAR] criteria) with symptoms present for at least 6 months.
  • Subject has ≥ 3 tender and ≥ 3 swollen joints at Screening and Baseline.

Exclusion Criteria:

  • Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pretreatment condition
  • Subject has an active infection or history of infections
  • Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease
  • Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus

Sites / Locations

  • SPARC Site 1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

SUNPG1623 dose I

SUNPG1623 dose II

SUNPG1623 dose III

SUNPG1623 dose IV

Placebo

Arm Description

low range dose

mid range dose

mid range dose

mid range dose to high dose

mid range dose to high dose

Outcomes

Primary Outcome Measures

Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate
The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein. For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.

Secondary Outcome Measures

Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate
The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein. For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.
Proportion of Subjects Achieving American College of Rheumatology50 Response Rate
The American College of Rheumatology50 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein. For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.
Proportion of Subjects Achieving American College of Rheumatology70 Response Rate
The American College of Rheumatology70 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein. For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.
Change From Baseline in Tender Joint Counts
Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.
Change From Baseline in Tender Joint Counts
Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.
Change From Baseline in Swollen Joint Counts
Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.
Change From Baseline in Swollen Joint Counts
Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.
Physician Global Assessment of Disease Activity Visual Analog Scale
100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)
Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale
100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)
Patient's Global Assessment of Disease Activity
100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)
Change From Baseline in Patient's Global Assessment of Disease Activity
100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)
Patient's Pain Assessment
100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).
Change From Baseline in Patient's Pain Assessment
100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).
Health Assessment Questionnaire- Disability Index
eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do). The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability
Change From Baseline in Health Assessment Questionnaire- Disability Index
eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do). The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability
Acute Phase C - Reactive Protein
C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood. CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation
Acute Phase C - Reactive Protein
C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood. CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation. Change from Baseline in C-Reactive Protein.
Erythrocyte Sedimentation Rate
An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.
Change From Baseline in Erythrocyte Sedimentation Rate
An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.
The Proportion of Subjects Who Require Adjustment of Background Therapy
Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate
The Disease Activity Score 28-item C-Reactive Protein: assessed across 28 joints including the shoulder, elbow, wrist, MCP (1 through 5), PIP (1 through 5) and knee, with all 14 joints assessed for each side of the body. It is a composite score derived from examination of the 28 joints for swelling and tenderness, global assessment of pain and overall status using a VAS and a blood marker of inflammation (hsCRP). DAS28-CRP(4) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96 TJC- tender joint count, SJC- swollen joint count, CRP- C reactive protein, GH - patient global health
Minimal Disease Activity
A psoriatic arthritis patient is defined as having a Minimal Disease Activity (MDA) response (Yes/No) when the patient meets at least 5 of the 7 following criteria: tender joint count ≤1; swollen joint count ≤1; PASI score ≤1 or BSA ≤3%; patient Arthritis Pain (VAS) ≤15 mm; patient's global arthritis assessment (VAS) ≤20 mm; HAQ-DI score ≤0.5; tender entheseal points (using LEI) ≤1.
Change From Baseline in Leeds Dactylitis Index (LDI)
tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw) Total score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score Standard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45 The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index. Lower Leeds Dactylitis Index score represent better outcome.
Change From Baseline in Leeds Dactylitis Index (LDI)
tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw) Total score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score Standard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45 The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index. Lower Leeds Dactylitis Index score represent better outcome.
Change From Baseline in Leeds Enthesitis Index (LEI)
The LEI examines tenderness at 6 sites: 2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6. Lower the score better is the outcome
Change From Baseline in Leeds Enthesitis Index (LEI)
The LEI examines tenderness at 6 sites: 2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6. Lower the score better is the outcome

Full Information

First Posted
November 30, 2016
Last Updated
January 3, 2023
Sponsor
Sun Pharmaceutical Industries Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02980692
Brief Title
Efficacy and Safety Study of SUNPG1623
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2b Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Active Psoriatic Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 19, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
September 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of SUNPG1623

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Psoriatic Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
391 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SUNPG1623 dose I
Arm Type
Experimental
Arm Description
low range dose
Arm Title
SUNPG1623 dose II
Arm Type
Experimental
Arm Description
mid range dose
Arm Title
SUNPG1623 dose III
Arm Type
Experimental
Arm Description
mid range dose
Arm Title
SUNPG1623 dose IV
Arm Type
Experimental
Arm Description
mid range dose to high dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
mid range dose to high dose
Intervention Type
Drug
Intervention Name(s)
SUNPG1623 I
Intervention Description
injection
Intervention Type
Drug
Intervention Name(s)
SUNPG1623 II
Intervention Description
injection
Intervention Type
Drug
Intervention Name(s)
SUNPG1623 III
Intervention Description
injection
Intervention Type
Drug
Intervention Name(s)
SUNPG1623 IV
Intervention Description
injection
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Intervention Description
injection
Primary Outcome Measure Information:
Title
Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate
Description
The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein. For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.
Time Frame
week 24
Secondary Outcome Measure Information:
Title
Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate
Description
The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein. For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.
Time Frame
week 52
Title
Proportion of Subjects Achieving American College of Rheumatology50 Response Rate
Description
The American College of Rheumatology50 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein. For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.
Time Frame
week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52
Title
Proportion of Subjects Achieving American College of Rheumatology70 Response Rate
Description
The American College of Rheumatology70 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein. For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100.
Time Frame
week 1, week 4, week 8, week 12, week 16, week 20, week 24, and week 52
Title
Change From Baseline in Tender Joint Counts
Description
Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.
Time Frame
week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Title
Change From Baseline in Tender Joint Counts
Description
Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.
Time Frame
Week 52
Title
Change From Baseline in Swollen Joint Counts
Description
Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.
Time Frame
week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Title
Change From Baseline in Swollen Joint Counts
Description
Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis.
Time Frame
Week 52
Title
Physician Global Assessment of Disease Activity Visual Analog Scale
Description
100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)
Time Frame
week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Title
Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale
Description
100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)
Time Frame
Week 52
Title
Patient's Global Assessment of Disease Activity
Description
100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)
Time Frame
week 1, week 4, week 8, week 12, week 16, week 20 and week 24
Title
Change From Baseline in Patient's Global Assessment of Disease Activity
Description
100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)
Time Frame
Week 52
Title
Patient's Pain Assessment
Description
100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).
Time Frame
week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Title
Change From Baseline in Patient's Pain Assessment
Description
100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).
Time Frame
Week 52
Title
Health Assessment Questionnaire- Disability Index
Description
eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do). The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability
Time Frame
week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Title
Change From Baseline in Health Assessment Questionnaire- Disability Index
Description
eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do). The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability
Time Frame
Week 52
Title
Acute Phase C - Reactive Protein
Description
C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood. CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation
Time Frame
week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Title
Acute Phase C - Reactive Protein
Description
C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood. CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation. Change from Baseline in C-Reactive Protein.
Time Frame
Week 52
Title
Erythrocyte Sedimentation Rate
Description
An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.
Time Frame
week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Title
Change From Baseline in Erythrocyte Sedimentation Rate
Description
An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation.
Time Frame
Week 52
Title
The Proportion of Subjects Who Require Adjustment of Background Therapy
Time Frame
Week 16
Title
Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate
Description
The Disease Activity Score 28-item C-Reactive Protein: assessed across 28 joints including the shoulder, elbow, wrist, MCP (1 through 5), PIP (1 through 5) and knee, with all 14 joints assessed for each side of the body. It is a composite score derived from examination of the 28 joints for swelling and tenderness, global assessment of pain and overall status using a VAS and a blood marker of inflammation (hsCRP). DAS28-CRP(4) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96 TJC- tender joint count, SJC- swollen joint count, CRP- C reactive protein, GH - patient global health
Time Frame
week 1, week 4, week 8, week 12, week 16, week 20, week 24 and Week 52
Title
Minimal Disease Activity
Description
A psoriatic arthritis patient is defined as having a Minimal Disease Activity (MDA) response (Yes/No) when the patient meets at least 5 of the 7 following criteria: tender joint count ≤1; swollen joint count ≤1; PASI score ≤1 or BSA ≤3%; patient Arthritis Pain (VAS) ≤15 mm; patient's global arthritis assessment (VAS) ≤20 mm; HAQ-DI score ≤0.5; tender entheseal points (using LEI) ≤1.
Time Frame
week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52
Title
Change From Baseline in Leeds Dactylitis Index (LDI)
Description
tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw) Total score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score Standard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45 The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index. Lower Leeds Dactylitis Index score represent better outcome.
Time Frame
week 4, week 12, and week 24
Title
Change From Baseline in Leeds Dactylitis Index (LDI)
Description
tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw) Total score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score Standard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45 The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index. Lower Leeds Dactylitis Index score represent better outcome.
Time Frame
Week 52
Title
Change From Baseline in Leeds Enthesitis Index (LEI)
Description
The LEI examines tenderness at 6 sites: 2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6. Lower the score better is the outcome
Time Frame
week 4, week 12 and week 24
Title
Change From Baseline in Leeds Enthesitis Index (LEI)
Description
The LEI examines tenderness at 6 sites: 2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6. Lower the score better is the outcome
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has provided written informed consent Subject is ≥ 18 years of age at time of Screening Subject must be on stable dose of NSAID for ≥ 4 weeks prior to initiation of IMP Subject has a negative evaluation for TB within 4 weeks before initiating IMP Subject has a diagnosis of PsA (by the Classification of Psoriatic Arthritis [CASPAR] criteria) with symptoms present for at least 6 months. Subject has ≥ 3 tender and ≥ 3 swollen joints at Screening and Baseline. Exclusion Criteria: Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pretreatment condition Subject has an active infection or history of infections Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus
Facility Information:
Facility Name
SPARC Site 1
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33985942
Citation
Mease PJ, Chohan S, Fructuoso FJG, Luggen ME, Rahman P, Raychaudhuri SP, Chou RC, Mendelsohn AM, Rozzo SJ, Gottlieb A. Efficacy and safety of tildrakizumab in patients with active psoriatic arthritis: results of a randomised, double-blind, placebo-controlled, multiple-dose, 52-week phase IIb study. Ann Rheum Dis. 2021 Sep;80(9):1147-1157. doi: 10.1136/annrheumdis-2020-219014. Epub 2021 May 13.
Results Reference
derived

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Efficacy and Safety Study of SUNPG1623

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