Efficacy and Safety Study of SUNPG1623
Sponsor
Sun Pharmaceutical Industries Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT02980692
Collaborator
(none)
391
1
5
29.2
13.4
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
391 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Apr 19, 2017
Actual Primary Completion Date
:
Mar 1, 2019
Actual Study Completion Date
:
Sep 24, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SUNPG1623 dose I low range dose |
Drug: SUNPG1623 I
injection
|
| Experimental: SUNPG1623 dose II mid range dose |
Drug: SUNPG1623 II
injection
Drug: PLACEBO
injection
|
| Experimental: SUNPG1623 dose III mid range dose |
Drug: SUNPG1623 III
injection
Drug: PLACEBO
injection
|
| Experimental: SUNPG1623 dose IV mid range dose to high dose |
Drug: SUNPG1623 IV
injection
Drug: PLACEBO
injection
|
| Placebo Comparator: Placebo mid range dose to high dose |
Drug: PLACEBO
injection
|
Outcome Measures
Primary Outcome Measures
- Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate [week 1, week 4, week 8, week 12, week 16, week 20 and week 24]
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.
Secondary Outcome Measures
- Proportion of Subjects Achieving American College of Rheumatology50 Response Rate [week 1, week 4, week 8, week 12, week 16, week 20, and week 24]
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.
- Proportion of Subjects Achieving American College of Rheumatology70 Response Rate [week 1, week 4, week 8, week 12, week 16, week 20, and week 24]
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.
- Change From Baseline in Tender Joint Counts [week 1, week 4, week 8, week 12, week 16, week 20, and week 24]
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 [week 1, week 4, week 8, week 12, week 16, week 20, and week 24]
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 [week 1, week 4, week 8, week 12, week 16, week 20, and week 24]
100 mm Visual analog scale with descriptors (verbal) : "very good" (0) to "very poor" (100)
- Patient's Global Assessment of Disease Activity [week 1, week 4, week 8, week 12, week 16, week 20 and week 24]
100 mm Visual analog scale descriptors (verbal) : "very well" (0) to "very poorly"(100)
- Patient's Pain Assessment [week 1, week 4, week 8, week 12, week 16, week 20, and week 24]
100 mm Visual Analog Scale with scale (verbal descriptors) "no pain" (0) to "worst possible pain" (100).
- Health Assessment Questionnaire- Disability Index [week 1, week 4, week 8, week 12, week 16, week 20, and week 24]
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 [week 1, week 4, week 8, week 12, week 16, week 20, and week 24]
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
- Erythrocyte Sedimentation Rate [week 1, week 4, week 8, week 12, week 16, week 20, and week 24]
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 [Week 16]
- Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate [week 1, week 4, week 8, week 12, week 16, week 20, and week 24]
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 [week 1, week 4, week 8, week 12, week 16, week 20, and week 24]
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) [week 4, week 12, and week 24]
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) [week 4, week 12 and week 24]
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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SPARC Site 1 | Middleburg Heights | Ohio | United States | 44130 |
Sponsors and Collaborators
- Sun Pharmaceutical Industries Limited
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier:
NCT02980692
Other Study ID Numbers:
- CLR_16_23
First Posted:
Dec 2, 2016
Last Update Posted:
Nov 1, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks |
| Period Title: Overall Study | |||||
| STARTED | 78 | 79 | 77 | 78 | 79 |
| COMPLETED | 69 | 73 | 65 | 69 | 68 |
| NOT COMPLETED | 9 | 6 | 12 | 9 | 11 |
Baseline Characteristics
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Total of all reporting groups |
| Overall Participants | 78 | 79 | 77 | 78 | 79 | 391 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
50.1
(13.28)
|
49.3
(11.24)
|
49.2
(11.85)
|
47.2
(13.35)
|
48.1
(13.30)
|
48.8
(12.61)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
46
59%
|
37
46.8%
|
47
61%
|
41
52.6%
|
44
55.7%
|
215
55%
|
| Male |
32
41%
|
42
53.2%
|
30
39%
|
37
47.4%
|
35
44.3%
|
176
45%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||
| Hispanic or Latino |
12
15.4%
|
16
20.3%
|
11
14.3%
|
9
11.5%
|
11
13.9%
|
59
15.1%
|
| Not Hispanic or Latino |
66
84.6%
|
63
79.7%
|
66
85.7%
|
69
88.5%
|
68
86.1%
|
332
84.9%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
1
1.3%
|
1
1.3%
|
3
3.8%
|
5
1.3%
|
| White |
76
97.4%
|
78
98.7%
|
75
97.4%
|
75
96.2%
|
74
93.7%
|
378
96.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
2
2.6%
|
1
1.3%
|
1
1.3%
|
2
2.6%
|
2
2.5%
|
8
2%
|
Outcome Measures
| 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. |
| Time Frame | week 1, week 4, week 8, week 12, week 16, week 20 and week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cochran-Mantel-Haenszel Analysis of ACR20 Response Rate At Week 24 (Missing Response = Non-response) - Primary Analysis (Full Analysis Set) |
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks |
| Measure Participants | 78 | 79 | 77 | 78 | 79 |
| Number [proportion of subjects] |
0.7949
|
0.7722
|
0.7143
|
0.7308
|
0.5063
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 I, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 II, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0006 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose III, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0088 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose IV, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0041 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| 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. |
| Time Frame | week 1, week 4, week 8, week 12, week 16, week 20, and week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cochran-Mantel-Haenszel Analysis of ACR50 Response Rates up to Week 24 Full Analysis Set |
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks |
| Measure Participants | 78 | 79 | 77 | 78 | 79 |
| Week 1 |
0
|
0.0253
|
0.0130
|
0.0128
|
0
|
| Week 4 |
0.0256
|
0.0506
|
0.0909
|
0.0385
|
0.0253
|
| Week 8 |
0.1667
|
0.0759
|
0.1299
|
0.1410
|
0.0759
|
| Week 12 |
0.1795
|
0.1772
|
0.2078
|
0.1923
|
0.0633
|
| Week 16 |
0.3077
|
0.2785
|
0.2727
|
0.2051
|
0.0506
|
| Week 20 |
0.4487
|
0.4177
|
0.2857
|
0.2308
|
0.1646
|
| Week 24 |
0.5256
|
0.5063
|
0.4545
|
0.3974
|
0.2405
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 I, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0002 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 II, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0006 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose III, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0059 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose IV, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0364 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| 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. |
| Time Frame | week 1, week 4, week 8, week 12, week 16, week 20, and week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cochran-Mantel-Haenszel Analysis of ACR70 Response Rates up to Week 24 Full Analysis Set |
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks |
| Measure Participants | 78 | 79 | 77 | 78 | 79 |
| Week 1 |
0
|
0.0127
|
0
|
0
|
0
|
| Week 4 |
0.0128
|
0.0127
|
0
|
0.0128
|
0.0127
|
| Week 8 |
0.0256
|
0.0380
|
0.0260
|
0.0256
|
0.0380
|
| Week 12 |
0.1026
|
0.0380
|
0.0649
|
0.1026
|
0.0127
|
| Week 16 |
0.1410
|
0.1266
|
0.1169
|
0.0897
|
0.0253
|
| Week 20 |
0.2051
|
0.2658
|
0.1429
|
0.1282
|
0.0380
|
| Week 24 |
0.2821
|
0.2911
|
0.2208
|
0.1667
|
0.1013
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 I, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0040 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose III, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0033 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose III, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0550 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose IV, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2495 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks |
| Measure Participants | 77 | 78 | 76 | 78 | 79 |
| Week 1 |
-1.5
(0.77)
|
-2.4
(0.76)
|
-2.5
(0.78)
|
-3.1
(0.76)
|
-2.1
(0.76)
|
| Week 4 |
-4.7
(0.89)
|
-4.9
(0.88)
|
-5.4
(0.89)
|
-3.9
(0.88)
|
-4.1
(0.87)
|
| Week 8 |
-7.1
(0.94)
|
-7.8
(0.92)
|
-8.6
(0.94)
|
-7.2
(0.93)
|
-6.9
(0.91)
|
| Week 12 |
-8.3
(0.96)
|
-10.0
(0.94)
|
-8.7
(0.95)
|
-7.8
(0.96)
|
-7.7
(0.94)
|
| Week 16 |
-10.3
(1.04)
|
-11.3
(1.01)
|
-10.7
(1.03)
|
-9.8
(1.04)
|
-8.4
(1.02)
|
| Week 20 |
-11.2
(1.09)
|
-12.3
(1.06)
|
-11.5
(1.07)
|
-11.4
(1.09)
|
-9.9
(1.06)
|
| Week 24 |
-11.9
(1.04)
|
-12.6
(1.01)
|
-12.9
(1.03)
|
-12.0
(1.04)
|
-9.4
(1.02)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 I, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0850 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 II, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0234 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose III, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0140 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose IV, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0731 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in Swollen Joint Counts up to Week 24 - (No Imputation) Full Analysis Set |
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks |
| Measure Participants | 77 | 78 | 76 | 78 | 79 |
| Week 1 |
-1.8
(0.51)
|
-2.1
(0.51)
|
-1.3
(0.52)
|
-2.4
(0.51)
|
-1.3
(0.51)
|
| Week 4 |
-4.1
(0.56)
|
-3.8
(0.55)
|
-3.8
(0.56)
|
-3.0
(0.55)
|
-3.1
(0.55)
|
| Week 8 |
-5.8
(0.55)
|
-5.5
(0.54)
|
-5.7
(0.55)
|
-5.0
(0.55)
|
-4.7
(0.54)
|
| Week 12 |
-7.3
(0.55)
|
-6.6
(0.54)
|
-6.2
(0.55)
|
-4.8
(0.55)
|
-4.9
(0.54)
|
| Week 16 |
-8.0
(0.56)
|
-7.2
(0.55)
|
-7.0
(0.55)
|
-6.0
(0.56)
|
-5.2
(0.55)
|
| Week 20 |
-8.3
(0.56)
|
-7.4
(0.55)
|
-7.4
(0.56)
|
-6.8
(0.56)
|
-6.0
(0.55)
|
| Week 24 |
-8.3
(0.52)
|
-7.7
(0.51)
|
-8.2
(0.52)
|
-7.6
(0.52)
|
-6.5
(0.51)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 I, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0111 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 II, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0774 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose III, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0190 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose IV, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1282 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks |
| Measure Participants | 77 | 78 | 76 | 78 | 79 |
| Week 1 |
-7.8
(1.69)
|
-8.0
(1.68)
|
-7.2
(1.70)
|
-6.2
(1.68)
|
-4.5
(1.67)
|
| Week 4 |
-14.3
(2.01)
|
-15.7
(1.99)
|
-15.1
(1.99)
|
-14.0
(1.99)
|
-9.7
(1.95)
|
| Week 8 |
-21.9
(2.20)
|
-23.6
(2.16)
|
-23.9
(2.18)
|
-20.8
(2.18)
|
-16.2
(2.13)
|
| Week 12 |
-27.9
(2.22)
|
-28.7
(2.17)
|
-27.6
(2.19)
|
-23.1
(2.22)
|
-18.5
(2.17)
|
| Week 16 |
-31.0
(2.08)
|
-32.1
(2.03)
|
-31.7
(2.05)
|
-30.8
(2.08)
|
-20.2
(2.04)
|
| Week 20 |
-36.7
(2.19)
|
-36.8
(2.13)
|
-31.0
(2.15)
|
-33.0
(2.19)
|
-24.3
(2.13)
|
| Week 24 |
-36.5
(2.15)
|
-38.8
(2.08)
|
-37.5
(2.11)
|
-36.3
(2.14)
|
-23.5
(2.09)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 I, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 II, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose III, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose IV, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks |
| Measure Participants | 77 | 78 | 76 | 78 | 79 |
| Week 1 |
-5.9
(1.85)
|
-7.5
(1.84)
|
-6.8
(1.87)
|
-6.4
(1.84)
|
-2.8
(1.84)
|
| Week 4 |
-7.5
(2.17)
|
-11.9
(2.14)
|
-9.5
(2.15)
|
-8.8
(2.14)
|
-5.9
(2.11)
|
| Week 8 |
-15.4
(2.30)
|
-15.5
(2.25)
|
-14.5
(2.28)
|
-13.1
(2.28)
|
-10.1
(2.23)
|
| Week 12 |
-18.1
(2.52)
|
-20.3
(2.46)
|
-16.1
(2.49)
|
-16.4
(2.51)
|
-11.2
(2.46)
|
| Week 16 |
-23.5
(2.63)
|
-22.0
(2.57)
|
-18.7
(2.59)
|
-19.4
(2.63)
|
-13.8
(2.58)
|
| Week 20 |
-29.7
(2.64)
|
-27.3
(2.57)
|
-22.7
(2.60)
|
-21.6
(2.64)
|
-15.6
(2.58)
|
| Week 24 |
-35.0
(2.60)
|
-33.3
(2.52)
|
-33.4
(2.56)
|
-30.4
(2.60)
|
-21.7
(2.54)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 I, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0003 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 II, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0012 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose III, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0011 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose IV, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0167 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in Patient's Pain Assessment up to Week 24 - (No Imputation) Full Analysis Set |
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks |
| Measure Participants | 77 | 78 | 76 | 78 | 79 |
| Week 1 |
-5.8
(1.96)
|
-8.1
(1.95)
|
-5.1
(1.98)
|
-5.8
(1.95)
|
-1.6
(1.95)
|
| Week 4 |
-9.8
(2.15)
|
-12.8
(2.12)
|
-8.9
(2.13)
|
-6.4
(2.12)
|
-3.9
(2.09)
|
| Week 8 |
-16.9
(2.42)
|
-16.1
(2.37)
|
-16.6
(2.41)
|
-11.9
(2.40)
|
-8.5
(2.35)
|
| Week 12 |
-19.4
(2.54)
|
-20.4
(2.48)
|
-15.6
(2.50)
|
-14.0
(2.53)
|
-11.5
(2.48)
|
| Week 16 |
-23.8
(2.58)
|
-23.2
(2.52)
|
-20.6
(2.55)
|
-19.3
(2.59)
|
-12.8
(2.54)
|
| Week 20 |
-29.8
(2.79)
|
-25.3
(2.71)
|
-21.4
(2.74)
|
-21.4
(2.78)
|
-17.1
(2.72)
|
| Week 24 |
-35.1
(2.69)
|
-31.6
(2.60)
|
-32.1
(2.64)
|
-28.8
(2.68)
|
-21.5
(2.63)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 I, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0003 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 II, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0055 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose III, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0039 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose IV, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0487 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks |
| Measure Participants | 77 | 78 | 76 | 78 | 79 |
| Week 1 |
-0.0374
(0.03454)
|
-0.0453
(0.03436)
|
-0.0552
(0.03492)
|
-0.0411
(0.03435)
|
-0.0045
(0.03439)
|
| Week 4 |
-0.0025
(0.04036)
|
-0.0736
(0.03984)
|
-0.0906
(0.03999)
|
-0.0409
(0.03989)
|
-0.0404
(0.03928)
|
| Week 8 |
-0.1510
(0.04709)
|
-0.1279
(0.04627)
|
-0.2035
(0.04687)
|
-0.1041
(0.04669)
|
-0.1265
(0.04588)
|
| Week 12 |
-0.1310
(0.04601)
|
-0.2140
(0.04507)
|
-0.2090
(0.04555)
|
-0.1731
(0.04597)
|
-0.1374
(0.04503)
|
| Week 16 |
-0.2061
(0.04890)
|
-0.2448
(0.04790)
|
-0.2343
(0.04843)
|
-0.2102
(0.04889)
|
-0.1580
(0.04801)
|
| Week 20 |
-0.3052
(0.05256)
|
-0.2868
(0.05128)
|
-0.2911
(0.05185)
|
-0.1947
(0.05244)
|
-0.2271
(0.05135)
|
| Week 24 |
-0.3013
(0.05196)
|
-0.3314
(0.05054)
|
-0.3337
(0.05128)
|
-0.2376
(0.05187)
|
-0.1827
(0.05102)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 I, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0987 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 II, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0360 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose III, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0346 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose IV, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4442 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in CRP (mg/L) up to Week 24 - (No Imputation) Full Analysis Set |
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks |
| Measure Participants | 77 | 78 | 76 | 78 | 79 |
| Week 1 |
0.19
(0.967)
|
-0.75
(0.961)
|
-0.50
(0.979)
|
2.08
(0.961)
|
0.51
(0.964)
|
| Week 4 |
-0.71
(1.239)
|
-3.41
(1.227)
|
-0.82
(1.223)
|
0.64
(1.222)
|
-0.28
(1.206)
|
| Week 8 |
-2.96
(1.506)
|
-3.21
(1.476)
|
-1.54
(1.502)
|
1.95
(1.495)
|
1.24
(1.465)
|
| Week 12 |
-2.21
(1.121)
|
-3.04
(1.097)
|
-2.59
(1.104)
|
0.11
(1.124)
|
1.49
(1.097)
|
| Week 16 |
-3.37
(1.505)
|
-3.57
(1.462)
|
-1.67
(1.485)
|
-1.58
(1.505)
|
2.25
(1.474)
|
| Week 20 |
-3.72
(1.708)
|
-2.76
(1.656)
|
-2.57
(1.677)
|
-0.61
(1.715)
|
4.60
(1.672)
|
| Week 24 |
-3.56
(1.088)
|
-2.33
(1.054)
|
-3.23
(1.071)
|
-2.06
(1.088)
|
0.55
(1.065)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 I, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0064 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 II, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0516 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose III, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0114 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose IV, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0820 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in ESR (mm/hr) up to Week 24 - (No Imputation) Full Analysis Set |
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks |
| Measure Participants | 70 | 68 | 69 | 68 | 62 |
| Week 1 |
-3.1
(1.39)
|
-3.0
(1.40)
|
-3.3
(1.41)
|
-1.1
(1.41)
|
-2.6
(1.45)
|
| Week 4 |
-6.9
(1.46)
|
-5.9
(1.48)
|
-5.5
(1.45)
|
-5.6
(1.47)
|
-4.8
(1.51)
|
| Week 8 |
-8.7
(1.58)
|
-6.5
(1.58)
|
-7.1
(1.58)
|
-5.5
(1.60)
|
-3.6
(1.64)
|
| Week 12 |
-8.6
(1.59)
|
-6.8
(1.59)
|
-7.9
(1.58)
|
-6.6
(1.62)
|
-2.3
(1.66)
|
| Week 16 |
-9.4
(1.93)
|
-8.4
(1.92)
|
-8.3
(1.91)
|
-6.0
(1.96)
|
-3.3
(2.02)
|
| Week 20 |
-9.6
(1.73)
|
-7.2
(1.72)
|
-9.2
(1.71)
|
-8.5
(1.76)
|
-4.4
(1.81)
|
| Week 24 |
-8.0
(1.86)
|
-6.9
(1.85)
|
-8.2
(1.84)
|
-8.7
(1.89)
|
-2.3
(1.95)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 I, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0351 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 II, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0876 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose III, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0269 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose IV, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0185 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | The Proportion of Subjects Who Require Adjustment of Background Therapy |
|---|---|
| Description | |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects Who Require Adjustment of Background Therapy at Week 16 Full Analysis Set |
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks |
| Measure Participants | 78 | 79 | 77 | 78 | 79 |
| Number [proportion of subjects] |
0
|
0.0127
|
0.0130
|
0.0256
|
0.0127
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 I, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Proportion with Adjustment of Background |
| Estimated Value | 1.27 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 3.73 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.26 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 II, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Proportion with Adjustment of Background |
| Estimated Value | 1.30 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 3.83 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.29 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose III, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Proportion with Adjustment of Background |
| Estimated Value | 2.56 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 6.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.79 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose IV, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Proportion with Adjustment of Background |
| Estimated Value | 1.27 | |
| Confidence Interval |
(2-Sided) 95% 0.00 to 3.73 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.26 |
|
| Estimation Comments | ||
| 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, and week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks |
| Measure Participants | 78 | 79 | 77 | 78 | 79 |
| Week 1 |
11.54
14.8%
|
12.66
16%
|
10.39
13.5%
|
5.13
6.6%
|
6.33
8%
|
| Week 4 |
20.51
26.3%
|
17.72
22.4%
|
15.58
20.2%
|
15.38
19.7%
|
13.92
17.6%
|
| Week 8 |
35.90
46%
|
29.11
36.8%
|
29.87
38.8%
|
23.08
29.6%
|
18.99
24%
|
| Week 12 |
38.46
49.3%
|
40.51
51.3%
|
31.17
40.5%
|
29.49
37.8%
|
18.99
24%
|
| Week 16 |
48.72
62.5%
|
48.10
60.9%
|
36.36
47.2%
|
35.90
46%
|
13.92
17.6%
|
| Week 20 |
60.26
77.3%
|
60.76
76.9%
|
37.66
48.9%
|
43.59
55.9%
|
21.52
27.2%
|
| Week 24 |
58.97
75.6%
|
64.56
81.7%
|
58.44
75.9%
|
53.85
69%
|
30.38
38.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 I, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0003 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 II, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose III, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0005 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose IV, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0034 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| 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, and week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Cochran-Mantel-Haenszel Analysis of MDA Response Rates up to Week 24 (Missing Response = Non-response) Full Analysis Set |
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks |
| Measure Participants | 78 | 79 | 77 | 78 | 79 |
| Week 1 |
0
0%
|
1.27
1.6%
|
0
0%
|
0
0%
|
0
0%
|
| Week 4 |
3.85
4.9%
|
1.27
1.6%
|
1.30
1.7%
|
2.56
3.3%
|
1.27
1.6%
|
| Week 8 |
3.85
4.9%
|
2.53
3.2%
|
2.60
3.4%
|
0
0%
|
2.53
3.2%
|
| Week 12 |
12.82
16.4%
|
8.86
11.2%
|
7.79
10.1%
|
8.97
11.5%
|
2.53
3.2%
|
| Week 16 |
12.82
16.4%
|
6.33
8%
|
7.79
10.1%
|
8.97
11.5%
|
1.27
1.6%
|
| Week 20 |
17.95
23%
|
15.19
19.2%
|
9.09
11.8%
|
8.97
11.5%
|
2.53
3.2%
|
| Week 24 |
33.33
42.7%
|
34.18
43.3%
|
28.57
37.1%
|
19.23
24.7%
|
6.33
8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 I, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 II, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.0001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose III, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0004 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose IV, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0172 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in LDI up to Week 24 - (No Imputation) Full Analysis Set |
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks |
| Measure Participants | 53 | 56 | 46 | 48 | 54 |
| Week 4 |
-17.385
(9.8336)
|
-17.918
(9.5818)
|
-19.150
(10.4630)
|
-5.385
(10.2843)
|
19.891
(9.6640)
|
| Week 12 |
-21.041
(7.8359)
|
-23.163
(7.5635)
|
-23.948
(8.3579)
|
-9.982
(8.2513)
|
-2.990
(7.7362)
|
| Week 24 |
-22.987
(3.5112)
|
-25.123
(3.2307)
|
-27.572
(3.5088)
|
-19.873
(3.4520)
|
-24.706
(3.2252)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 I, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7081 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 II, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9244 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose III, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5365 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose IV, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2925 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in LEI up to Week 24 - (No Imputation) Full Analysis Set |
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks |
| Measure Participants | 72 | 77 | 75 | 76 | 78 |
| Week 4 |
-0.5
(0.15)
|
-0.4
(0.14)
|
-0.5
(0.14)
|
-0.4
(0.14)
|
-0.4
(0.14)
|
| Week 12 |
-0.8
(0.15)
|
-0.7
(0.14)
|
-0.9
(0.15)
|
-0.8
(0.15)
|
-0.7
(0.14)
|
| Week 24 |
-1.3
(0.16)
|
-0.9
(0.15)
|
-1.2
(0.15)
|
-1.1
(0.15)
|
-0.8
(0.15)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 I, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0203 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 II, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5194 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose III, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0599 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | SUNPG1623 Dose IV, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1220 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Adverse Events
| Time Frame | week 52 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo | |||||
| Arm/Group Description | Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | |||||
All Cause Mortality |
||||||||||
| SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/78 (1.3%) | 0/79 (0%) | 0/77 (0%) | 0/78 (0%) | 0/79 (0%) | |||||
Serious Adverse Events |
||||||||||
| SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/78 (6.4%) | 3/79 (3.8%) | 3/77 (3.9%) | 4/78 (5.1%) | 5/79 (6.3%) | |||||
| Cardiac disorders | ||||||||||
| Acute myocardial infarction | 0/78 (0%) | 0 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 1/79 (1.3%) | 1 |
| Myocardial infarction | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
| Angina pectoris | 0/78 (0%) | 0 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 |
| General disorders | ||||||||||
| Chest pain | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
| Multiple organ dysfunction syndrome | 0/78 (0%) | 0 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 1/79 (1.3%) | 1 |
| Infections and infestations | ||||||||||
| Bronchitis | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
| Chronic tonsillitis | 0/78 (0%) | 0 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 |
| Pnemonia | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||
| Ankle fracture | 0/78 (0%) | 0 | 0/79 (0%) | 0 | 1/77 (1.3%) | 1 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
| Toxicity to various agents | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||
| Hypokalemia | 0/78 (0%) | 0 | 0/79 (0%) | 0 | 1/77 (1.3%) | 1 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||
| Osteoarthritis | 0/78 (0%) | 0 | 0/79 (0%) | 0 | 1/77 (1.3%) | 1 | 0/78 (0%) | 0 | 1/79 (1.3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Intraductal proliferative breast lesion | 0/78 (0%) | 0 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 |
| Parathyroid tumour benign | 0/78 (0%) | 0 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 1/79 (1.3%) | 1 |
| Nervous system disorders | ||||||||||
| Lumbar radiculopathy | 0/78 (0%) | 0 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 |
| Multiple sclerosis | 0/78 (0%) | 0 | 1/79 (1.3%) | 1 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
| Syncope | 0/78 (0%) | 0 | 0/79 (0%) | 0 | 1/77 (1.3%) | 1 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||||||||
| Abortion spontaneous | 0/78 (0%) | 0 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 |
| Ovarian cyst ruptured | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||
| Ovarian cyst | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Chronic obstructive pulmonary disease | 0/78 (0%) | 0 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 1/79 (1.3%) | 1 |
| Dyspnea | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
| Pleurisy | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
| Respiratory failure | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
| Vascular disorders | ||||||||||
| Hypertension | 0/78 (0%) | 0 | 2/79 (2.5%) | 2 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||
| SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/78 (2.6%) | 0/79 (0%) | 1/77 (1.3%) | 1/78 (1.3%) | 1/79 (1.3%) | |||||
| Cardiac disorders | ||||||||||
| Acute myocardial infarction | 0/78 (0%) | 0 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 1/79 (1.3%) | 1 |
| Infections and infestations | ||||||||||
| Pneumonia | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
| Pyelonephritis | 0/78 (0%) | 0 | 0/79 (0%) | 0 | 1/77 (1.3%) | 1 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
| Urinary tract infection | 0/78 (0%) | 0 | 0/79 (0%) | 0 | 1/77 (1.3%) | 1 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Intraductal proliferative breast lesion | 0/78 (0%) | 0 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Pleurisy | 1/78 (1.3%) | 1 | 0/79 (0%) | 0 | 0/77 (0%) | 0 | 0/78 (0%) | 0 | 0/79 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Head-Clinical Development |
|---|---|
| Organization | Sun Pharma Advanced Research Company Limited |
| Phone | 912266455645 |
| clinical.trials@sparcmail.com |
Responsible Party:
Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier:
NCT02980692
Other Study ID Numbers:
- CLR_16_23
First Posted:
Dec 2, 2016
Last Update Posted:
Nov 1, 2021
Last Verified:
Oct 1, 2021