Active Psoriatic Arthritis
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of SUNPG1623
Interventions
DRUGSUNPG1623 I
injection
DRUGSUNPG1623 II
injection
DRUGSUNPG1623 III
injection
DRUGSUNPG1623 IV
injection
DRUGPLACEBO
injection
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate | 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. 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate | week 52 | 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 | week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52 | 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 | week 1, week 4, week 8, week 12, week 16, week 20, week 24, and week 52 | 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 | 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) |
| Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale | Week 52 | 100 mm Visual analog scale with descriptors (verbal) : very good (0) to very poor (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). |
| Change From Baseline in Patient's Pain Assessment | Week 52 | 100 mm Visual Analog Scale with scale (verbal descriptors) no pain (0) to worst possible pain (100). |
| Change From Baseline in Patient's Global Assessment of Disease Activity | Week 52 | 100 mm Visual analog scale descriptors (verbal) : very well (0) to very poorly(100) |
| Change From Baseline in Health Assessment Questionnaire- Disability Index | Week 52 | 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. |
| Change From Baseline in Erythrocyte Sedimentation Rate | Week 52 | 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, week 24 and Week 52 | 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, week 24 and week 52 | 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: 1. tender joint count ≤1; 2. swollen joint count ≤1; 3. PASI score ≤1 or BSA ≤3%; 4. patient Arthritis Pain (VAS) ≤15 mm; 5. patient's global arthritis assessment (VAS) ≤20 mm; 6. HAQ-DI score ≤0.5; 7. 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SUNPG1623 I Group: SUNPG1623 I dosage: Short-term dose dosage form: subcutaneous injection frequency of administration: q4 weeks | 78 |
| SUNPG1623 II Group: SUNPG1623 II dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | 79 |
| SUNPG1623 Dose III Group: SUNPG1623 III dosage: Mid-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks | 77 |
| SUNPG1623 Dose IV Group: SUNPG1623 IV dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks Subjects who received SUNPG1623 Dose IV during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48 | 78 |
| Placebo Group: Placebo dosage: Mid to long-term dose dosage form: subcutaneous injection frequency of administration: q12 weeks Subjects who received placebo during Part 1 but failed to show clinical response to treatment at Week 24 entered Part 2 and received SUNPG1623 II until Week 48 | 79 |
| Total | 391 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Double-blind Follow-up Period | Adverse Event | 0 | 0 | 0 | 1 | 1 |
| Double-blind Follow-up Period | Failure to show sufficient response to treatment at Week 24 | 0 | 2 | 1 | 0 | 0 |
| Double-blind Follow-up Period | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 |
| Double-blind Follow-up Period | Other | 0 | 0 | 1 | 1 | 3 |
| Double-blind Follow-up Period | Pregnancy | 0 | 0 | 1 | 1 | 0 |
| Double-blind Follow-up Period | Withdrawal by Subject | 0 | 1 | 0 | 1 | 1 |
| Double Blind Placebo Controlled Period | Adverse Event | 1 | 2 | 1 | 2 | 0 |
| Double Blind Placebo Controlled Period | Failure to show sufficient response to treatment at Week 24 | 9 | 12 | 13 | 0 | 0 |
| Double Blind Placebo Controlled Period | Investigator Decision | 0 | 0 | 0 | 2 | 0 |
| Double Blind Placebo Controlled Period | Lost to Follow-up | 1 | 0 | 1 | 1 | 0 |
| Double Blind Placebo Controlled Period | Other | 1 | 0 | 0 | 0 | 1 |
| Double Blind Placebo Controlled Period | Protocol Violation | 2 | 0 | 1 | 0 | 0 |
| Double Blind Placebo Controlled Period | Withdrawal by Subject | 2 | 1 | 1 | 2 | 4 |
Baseline characteristics
| Characteristic | SUNPG1623 I | SUNPG1623 II | SUNPG1623 Dose III | SUNPG1623 Dose IV | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 50.1 years STANDARD_DEVIATION 13.28 | 49.3 years STANDARD_DEVIATION 11.24 | 49.2 years STANDARD_DEVIATION 11.85 | 47.2 years STANDARD_DEVIATION 13.35 | 48.1 years STANDARD_DEVIATION 13.3 | 48.8 years STANDARD_DEVIATION 12.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 16 Participants | 11 Participants | 9 Participants | 11 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 63 Participants | 66 Participants | 69 Participants | 68 Participants | 332 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) White | 76 Participants | 78 Participants | 75 Participants | 75 Participants | 74 Participants | 378 Participants |
| Sex: Female, Male Female | 46 Participants | 37 Participants | 47 Participants | 41 Participants | 44 Participants | 215 Participants |
| Sex: Female, Male Male | 32 Participants | 42 Participants | 30 Participants | 37 Participants | 35 Participants | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 79 | 0 / 77 | 0 / 78 | 0 / 79 | 0 / 78 | 0 / 79 | 0 / 77 | 0 / 78 | 0 / 79 | 1 / 78 | 0 / 79 | 0 / 77 | 0 / 78 | 0 / 79 |
| other Total, other adverse events | 17 / 78 | 18 / 79 | 16 / 77 | 22 / 78 | 18 / 79 | 14 / 78 | 11 / 79 | 6 / 77 | 18 / 78 | 9 / 79 | 8 / 78 | 1 / 79 | 3 / 77 | 8 / 78 | 8 / 79 |
| serious Total, serious adverse events | 2 / 78 | 2 / 79 | 2 / 77 | 1 / 78 | 2 / 79 | 0 / 78 | 0 / 79 | 0 / 77 | 3 / 78 | 1 / 79 | 3 / 78 | 1 / 79 | 1 / 77 | 1 / 78 | 2 / 79 |
Outcome results
Primary
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.
Time frame: week 24
Population: Cochran-Mantel-Haenszel Analysis of ACR20 Response Rate At Week 24 (Missing Response = Non-response) - Primary Analysis (Full Analysis Set)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SUNPG1623 I | Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate | 0.7949 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate | 0.7722 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate | 0.7143 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate | 0.7308 proportion of subjects |
| Placebo | Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate | 0.5063 proportion of subjects |
p-value: 0.0001Cochran-Mantel-Haenszel
p-value: 0.0006Cochran-Mantel-Haenszel
p-value: 0.0088Cochran-Mantel-Haenszel
p-value: 0.0041Cochran-Mantel-Haenszel
Secondary
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.
Time frame: Week 52
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SUNPG1623 I | Acute Phase C - Reactive Protein | -3.43 mg/L | Standard Deviation 12.506 |
| SUNPG1623 II | Acute Phase C - Reactive Protein | -3.68 mg/L | Standard Deviation 10.77 |
| SUNPG1623 Dose III | Acute Phase C - Reactive Protein | -6.05 mg/L | Standard Deviation 19.004 |
| SUNPG1623 Dose IV | Acute Phase C - Reactive Protein | -4.61 mg/L | Standard Deviation 9.508 |
| Placebo | Acute Phase C - Reactive Protein | -6.75 mg/L | Standard Deviation 19.649 |
Secondary
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
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Population: Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in CRP (mg/L) up to Week 24 - (No Imputation) Full Analysis Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| SUNPG1623 I | Acute Phase C - Reactive Protein | Week 8 | -2.96 mg/L | Standard Error 1.506 |
| SUNPG1623 I | Acute Phase C - Reactive Protein | Week 20 | -3.72 mg/L | Standard Error 1.708 |
| SUNPG1623 I | Acute Phase C - Reactive Protein | Week 16 | -3.37 mg/L | Standard Error 1.505 |
| SUNPG1623 I | Acute Phase C - Reactive Protein | Week 12 | -2.21 mg/L | Standard Error 1.121 |
| SUNPG1623 I | Acute Phase C - Reactive Protein | Week 24 | -3.56 mg/L | Standard Error 1.088 |
| SUNPG1623 I | Acute Phase C - Reactive Protein | Week 4 | -0.71 mg/L | Standard Error 1.239 |
| SUNPG1623 I | Acute Phase C - Reactive Protein | Week 1 | 0.19 mg/L | Standard Error 0.967 |
| SUNPG1623 II | Acute Phase C - Reactive Protein | Week 4 | -3.41 mg/L | Standard Error 1.227 |
| SUNPG1623 II | Acute Phase C - Reactive Protein | Week 8 | -3.21 mg/L | Standard Error 1.476 |
| SUNPG1623 II | Acute Phase C - Reactive Protein | Week 1 | -0.75 mg/L | Standard Error 0.961 |
| SUNPG1623 II | Acute Phase C - Reactive Protein | Week 24 | -2.33 mg/L | Standard Error 1.054 |
| SUNPG1623 II | Acute Phase C - Reactive Protein | Week 20 | -2.76 mg/L | Standard Error 1.656 |
| SUNPG1623 II | Acute Phase C - Reactive Protein | Week 16 | -3.57 mg/L | Standard Error 1.462 |
| SUNPG1623 II | Acute Phase C - Reactive Protein | Week 12 | -3.04 mg/L | Standard Error 1.097 |
| SUNPG1623 Dose III | Acute Phase C - Reactive Protein | Week 8 | -1.54 mg/L | Standard Error 1.502 |
| SUNPG1623 Dose III | Acute Phase C - Reactive Protein | Week 1 | -0.50 mg/L | Standard Error 0.979 |
| SUNPG1623 Dose III | Acute Phase C - Reactive Protein | Week 4 | -0.82 mg/L | Standard Error 1.223 |
| SUNPG1623 Dose III | Acute Phase C - Reactive Protein | Week 12 | -2.59 mg/L | Standard Error 1.104 |
| SUNPG1623 Dose III | Acute Phase C - Reactive Protein | Week 16 | -1.67 mg/L | Standard Error 1.485 |
| SUNPG1623 Dose III | Acute Phase C - Reactive Protein | Week 20 | -2.57 mg/L | Standard Error 1.677 |
| SUNPG1623 Dose III | Acute Phase C - Reactive Protein | Week 24 | -3.23 mg/L | Standard Error 1.071 |
| SUNPG1623 Dose IV | Acute Phase C - Reactive Protein | Week 20 | -0.61 mg/L | Standard Error 1.715 |
| SUNPG1623 Dose IV | Acute Phase C - Reactive Protein | Week 16 | -1.58 mg/L | Standard Error 1.505 |
| SUNPG1623 Dose IV | Acute Phase C - Reactive Protein | Week 4 | 0.64 mg/L | Standard Error 1.222 |
| SUNPG1623 Dose IV | Acute Phase C - Reactive Protein | Week 1 | 2.08 mg/L | Standard Error 0.961 |
| SUNPG1623 Dose IV | Acute Phase C - Reactive Protein | Week 8 | 1.95 mg/L | Standard Error 1.495 |
| SUNPG1623 Dose IV | Acute Phase C - Reactive Protein | Week 12 | 0.11 mg/L | Standard Error 1.124 |
| SUNPG1623 Dose IV | Acute Phase C - Reactive Protein | Week 24 | -2.06 mg/L | Standard Error 1.088 |
| Placebo | Acute Phase C - Reactive Protein | Week 4 | -0.28 mg/L | Standard Error 1.206 |
| Placebo | Acute Phase C - Reactive Protein | Week 24 | 0.55 mg/L | Standard Error 1.065 |
| Placebo | Acute Phase C - Reactive Protein | Week 16 | 2.25 mg/L | Standard Error 1.474 |
| Placebo | Acute Phase C - Reactive Protein | Week 12 | 1.49 mg/L | Standard Error 1.097 |
| Placebo | Acute Phase C - Reactive Protein | Week 20 | 4.60 mg/L | Standard Error 1.672 |
| Placebo | Acute Phase C - Reactive Protein | Week 8 | 1.24 mg/L | Standard Error 1.465 |
| Placebo | Acute Phase C - Reactive Protein | Week 1 | 0.51 mg/L | Standard Error 0.964 |
p-value: 0.0064Cochran-Mantel-Haenszel
p-value: 0.0516Cochran-Mantel-Haenszel
p-value: 0.0114Cochran-Mantel-Haenszel
p-value: 0.082Cochran-Mantel-Haenszel
Secondary
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.
Time frame: Week 52
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SUNPG1623 I | Change From Baseline in Erythrocyte Sedimentation Rate | -7.2 mm/hr | Standard Deviation 19.58 |
| SUNPG1623 II | Change From Baseline in Erythrocyte Sedimentation Rate | -7.2 mm/hr | Standard Deviation 15.26 |
| SUNPG1623 Dose III | Change From Baseline in Erythrocyte Sedimentation Rate | -8.9 mm/hr | Standard Deviation 20.48 |
| SUNPG1623 Dose IV | Change From Baseline in Erythrocyte Sedimentation Rate | -9.7 mm/hr | Standard Deviation 19.02 |
| Placebo | Change From Baseline in Erythrocyte Sedimentation Rate | -9.2 mm/hr | Standard Deviation 20.47 |
Secondary
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
Time frame: Week 52
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SUNPG1623 I | Change From Baseline in Health Assessment Questionnaire- Disability Index | -0.4869 score for the disability index | Standard Deviation 0.52093 |
| SUNPG1623 II | Change From Baseline in Health Assessment Questionnaire- Disability Index | -0.5430 score for the disability index | Standard Deviation 0.59145 |
| SUNPG1623 Dose III | Change From Baseline in Health Assessment Questionnaire- Disability Index | -0.4857 score for the disability index | Standard Deviation 0.56968 |
| SUNPG1623 Dose IV | Change From Baseline in Health Assessment Questionnaire- Disability Index | -0.4583 score for the disability index | Standard Deviation 0.52285 |
| Placebo | Change From Baseline in Health Assessment Questionnaire- Disability Index | -0.4700 score for the disability index | Standard Deviation 0.54013 |
Secondary
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.
Time frame: week 4, week 12, and week 24
Population: Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in LDI up to Week 24 - (No Imputation) Full Analysis Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| SUNPG1623 I | Change From Baseline in Leeds Dactylitis Index (LDI) | Week 24 | -22.987 score on a scale | Standard Error 3.5112 |
| SUNPG1623 I | Change From Baseline in Leeds Dactylitis Index (LDI) | Week 12 | -21.041 score on a scale | Standard Error 7.8359 |
| SUNPG1623 I | Change From Baseline in Leeds Dactylitis Index (LDI) | Week 4 | -17.385 score on a scale | Standard Error 9.8336 |
| SUNPG1623 II | Change From Baseline in Leeds Dactylitis Index (LDI) | Week 24 | -25.123 score on a scale | Standard Error 3.2307 |
| SUNPG1623 II | Change From Baseline in Leeds Dactylitis Index (LDI) | Week 4 | -17.918 score on a scale | Standard Error 9.5818 |
| SUNPG1623 II | Change From Baseline in Leeds Dactylitis Index (LDI) | Week 12 | -23.163 score on a scale | Standard Error 7.5635 |
| SUNPG1623 Dose III | Change From Baseline in Leeds Dactylitis Index (LDI) | Week 24 | -27.572 score on a scale | Standard Error 3.5088 |
| SUNPG1623 Dose III | Change From Baseline in Leeds Dactylitis Index (LDI) | Week 12 | -23.948 score on a scale | Standard Error 8.3579 |
| SUNPG1623 Dose III | Change From Baseline in Leeds Dactylitis Index (LDI) | Week 4 | -19.150 score on a scale | Standard Error 10.463 |
| SUNPG1623 Dose IV | Change From Baseline in Leeds Dactylitis Index (LDI) | Week 24 | -19.873 score on a scale | Standard Error 3.452 |
| SUNPG1623 Dose IV | Change From Baseline in Leeds Dactylitis Index (LDI) | Week 4 | -5.385 score on a scale | Standard Error 10.2843 |
| SUNPG1623 Dose IV | Change From Baseline in Leeds Dactylitis Index (LDI) | Week 12 | -9.982 score on a scale | Standard Error 8.2513 |
| Placebo | Change From Baseline in Leeds Dactylitis Index (LDI) | Week 4 | 19.891 score on a scale | Standard Error 9.664 |
| Placebo | Change From Baseline in Leeds Dactylitis Index (LDI) | Week 24 | -24.706 score on a scale | Standard Error 3.2252 |
| Placebo | Change From Baseline in Leeds Dactylitis Index (LDI) | Week 12 | -2.990 score on a scale | Standard Error 7.7362 |
p-value: 0.7081Cochran-Mantel-Haenszel
p-value: 0.9244Cochran-Mantel-Haenszel
p-value: 0.5365Cochran-Mantel-Haenszel
p-value: 0.2925Cochran-Mantel-Haenszel
Secondary
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.
Time frame: Week 52
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SUNPG1623 I | Change From Baseline in Leeds Dactylitis Index (LDI) | -14.453 score on a scale | Standard Deviation 31.9358 |
| SUNPG1623 II | Change From Baseline in Leeds Dactylitis Index (LDI) | -18.883 score on a scale | Standard Deviation 57.1147 |
| SUNPG1623 Dose III | Change From Baseline in Leeds Dactylitis Index (LDI) | -27.084 score on a scale | Standard Deviation 76.2272 |
| SUNPG1623 Dose IV | Change From Baseline in Leeds Dactylitis Index (LDI) | -26.173 score on a scale | Standard Deviation 87.5367 |
| Placebo | Change From Baseline in Leeds Dactylitis Index (LDI) | -50.399 score on a scale | Standard Deviation 141.677 |
Secondary
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
Time frame: week 4, week 12 and week 24
Population: Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in LEI up to Week 24 - (No Imputation) Full Analysis Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| SUNPG1623 I | Change From Baseline in Leeds Enthesitis Index (LEI) | Week 4 | -0.5 score on a scale | Standard Error 0.15 |
| SUNPG1623 I | Change From Baseline in Leeds Enthesitis Index (LEI) | Week 24 | -1.3 score on a scale | Standard Error 0.16 |
| SUNPG1623 I | Change From Baseline in Leeds Enthesitis Index (LEI) | Week 12 | -0.8 score on a scale | Standard Error 0.15 |
| SUNPG1623 II | Change From Baseline in Leeds Enthesitis Index (LEI) | Week 12 | -0.7 score on a scale | Standard Error 0.14 |
| SUNPG1623 II | Change From Baseline in Leeds Enthesitis Index (LEI) | Week 4 | -0.4 score on a scale | Standard Error 0.14 |
| SUNPG1623 II | Change From Baseline in Leeds Enthesitis Index (LEI) | Week 24 | -0.9 score on a scale | Standard Error 0.15 |
| SUNPG1623 Dose III | Change From Baseline in Leeds Enthesitis Index (LEI) | Week 4 | -0.5 score on a scale | Standard Error 0.14 |
| SUNPG1623 Dose III | Change From Baseline in Leeds Enthesitis Index (LEI) | Week 12 | -0.9 score on a scale | Standard Error 0.15 |
| SUNPG1623 Dose III | Change From Baseline in Leeds Enthesitis Index (LEI) | Week 24 | -1.2 score on a scale | Standard Error 0.15 |
| SUNPG1623 Dose IV | Change From Baseline in Leeds Enthesitis Index (LEI) | Week 4 | -0.4 score on a scale | Standard Error 0.14 |
| SUNPG1623 Dose IV | Change From Baseline in Leeds Enthesitis Index (LEI) | Week 24 | -1.1 score on a scale | Standard Error 0.15 |
| SUNPG1623 Dose IV | Change From Baseline in Leeds Enthesitis Index (LEI) | Week 12 | -0.8 score on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in Leeds Enthesitis Index (LEI) | Week 12 | -0.7 score on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in Leeds Enthesitis Index (LEI) | Week 4 | -0.4 score on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in Leeds Enthesitis Index (LEI) | Week 24 | -0.8 score on a scale | Standard Error 0.15 |
p-value: 0.0203Cochran-Mantel-Haenszel
p-value: 0.5194Cochran-Mantel-Haenszel
p-value: 0.0599Cochran-Mantel-Haenszel
p-value: 0.122Cochran-Mantel-Haenszel
Secondary
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
Time frame: Week 52
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SUNPG1623 I | Change From Baseline in Leeds Enthesitis Index (LEI) | -1.3 score on a scale | Standard Deviation 1.86 |
| SUNPG1623 II | Change From Baseline in Leeds Enthesitis Index (LEI) | -1.0 score on a scale | Standard Deviation 1.56 |
| SUNPG1623 Dose III | Change From Baseline in Leeds Enthesitis Index (LEI) | -1.7 score on a scale | Standard Deviation 2.08 |
| SUNPG1623 Dose IV | Change From Baseline in Leeds Enthesitis Index (LEI) | -1.2 score on a scale | Standard Deviation 1.75 |
| Placebo | Change From Baseline in Leeds Enthesitis Index (LEI) | -1.2 score on a scale | Standard Deviation 1.82 |
Secondary
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)
Time frame: Week 52
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SUNPG1623 I | Change From Baseline in Patient's Global Assessment of Disease Activity | -42.2 scores on a visual analog scale | Standard Deviation 22.74 |
| SUNPG1623 II | Change From Baseline in Patient's Global Assessment of Disease Activity | -43.8 scores on a visual analog scale | Standard Deviation 24.01 |
| SUNPG1623 Dose III | Change From Baseline in Patient's Global Assessment of Disease Activity | -38.4 scores on a visual analog scale | Standard Deviation 27.9 |
| SUNPG1623 Dose IV | Change From Baseline in Patient's Global Assessment of Disease Activity | -37.9 scores on a visual analog scale | Standard Deviation 24.65 |
| Placebo | Change From Baseline in Patient's Global Assessment of Disease Activity | -40.5 scores on a visual analog scale | Standard Deviation 28.13 |
Secondary
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).
Time frame: Week 52
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SUNPG1623 I | Change From Baseline in Patient's Pain Assessment | -40.7 scores on a visual analog scale | Standard Deviation 21.59 |
| SUNPG1623 II | Change From Baseline in Patient's Pain Assessment | -42.7 scores on a visual analog scale | Standard Deviation 25.67 |
| SUNPG1623 Dose III | Change From Baseline in Patient's Pain Assessment | -38.0 scores on a visual analog scale | Standard Deviation 29.26 |
| SUNPG1623 Dose IV | Change From Baseline in Patient's Pain Assessment | -37.6 scores on a visual analog scale | Standard Deviation 26.63 |
| Placebo | Change From Baseline in Patient's Pain Assessment | -41.0 scores on a visual analog scale | Standard Deviation 29.83 |
Secondary
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)
Time frame: Week 52
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SUNPG1623 I | Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale | -40.0 scores on a visual analog scale | Standard Deviation 17.38 |
| SUNPG1623 II | Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale | -44.3 scores on a visual analog scale | Standard Deviation 19.73 |
| SUNPG1623 Dose III | Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale | -45.3 scores on a visual analog scale | Standard Deviation 19.84 |
| SUNPG1623 Dose IV | Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale | -42.7 scores on a visual analog scale | Standard Deviation 19.18 |
| Placebo | Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale | -42.0 scores on a visual analog scale | Standard Deviation 20.41 |
Secondary
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.
Time frame: Week 52
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SUNPG1623 I | Change From Baseline in Swollen Joint Counts | -8.7 Swollen Joint Counts | Standard Deviation 6.88 |
| SUNPG1623 II | Change From Baseline in Swollen Joint Counts | -7.5 Swollen Joint Counts | Standard Deviation 7.07 |
| SUNPG1623 Dose III | Change From Baseline in Swollen Joint Counts | -9.2 Swollen Joint Counts | Standard Deviation 7.62 |
| SUNPG1623 Dose IV | Change From Baseline in Swollen Joint Counts | -7.5 Swollen Joint Counts | Standard Deviation 5.78 |
| Placebo | Change From Baseline in Swollen Joint Counts | -9.0 Swollen Joint Counts | Standard Deviation 8.8 |
Secondary
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.
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Population: Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in Swollen Joint Counts up to Week 24 - (No Imputation) Full Analysis Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| SUNPG1623 I | Change From Baseline in Swollen Joint Counts | Week 16 | -8.0 Swollen Joint Counts | Standard Error 0.56 |
| SUNPG1623 I | Change From Baseline in Swollen Joint Counts | Week 1 | -1.8 Swollen Joint Counts | Standard Error 0.51 |
| SUNPG1623 I | Change From Baseline in Swollen Joint Counts | Week 4 | -4.1 Swollen Joint Counts | Standard Error 0.56 |
| SUNPG1623 I | Change From Baseline in Swollen Joint Counts | Week 20 | -8.3 Swollen Joint Counts | Standard Error 0.56 |
| SUNPG1623 I | Change From Baseline in Swollen Joint Counts | Week 24 | -8.3 Swollen Joint Counts | Standard Error 0.52 |
| SUNPG1623 I | Change From Baseline in Swollen Joint Counts | Week 8 | -5.8 Swollen Joint Counts | Standard Error 0.55 |
| SUNPG1623 I | Change From Baseline in Swollen Joint Counts | Week 12 | -7.3 Swollen Joint Counts | Standard Error 0.55 |
| SUNPG1623 II | Change From Baseline in Swollen Joint Counts | Week 4 | -3.8 Swollen Joint Counts | Standard Error 0.55 |
| SUNPG1623 II | Change From Baseline in Swollen Joint Counts | Week 1 | -2.1 Swollen Joint Counts | Standard Error 0.51 |
| SUNPG1623 II | Change From Baseline in Swollen Joint Counts | Week 8 | -5.5 Swollen Joint Counts | Standard Error 0.54 |
| SUNPG1623 II | Change From Baseline in Swollen Joint Counts | Week 12 | -6.6 Swollen Joint Counts | Standard Error 0.54 |
| SUNPG1623 II | Change From Baseline in Swollen Joint Counts | Week 20 | -7.4 Swollen Joint Counts | Standard Error 0.55 |
| SUNPG1623 II | Change From Baseline in Swollen Joint Counts | Week 16 | -7.2 Swollen Joint Counts | Standard Error 0.55 |
| SUNPG1623 II | Change From Baseline in Swollen Joint Counts | Week 24 | -7.7 Swollen Joint Counts | Standard Error 0.51 |
| SUNPG1623 Dose III | Change From Baseline in Swollen Joint Counts | Week 16 | -7.0 Swollen Joint Counts | Standard Error 0.55 |
| SUNPG1623 Dose III | Change From Baseline in Swollen Joint Counts | Week 1 | -1.3 Swollen Joint Counts | Standard Error 0.52 |
| SUNPG1623 Dose III | Change From Baseline in Swollen Joint Counts | Week 24 | -8.2 Swollen Joint Counts | Standard Error 0.52 |
| SUNPG1623 Dose III | Change From Baseline in Swollen Joint Counts | Week 20 | -7.4 Swollen Joint Counts | Standard Error 0.56 |
| SUNPG1623 Dose III | Change From Baseline in Swollen Joint Counts | Week 8 | -5.7 Swollen Joint Counts | Standard Error 0.55 |
| SUNPG1623 Dose III | Change From Baseline in Swollen Joint Counts | Week 12 | -6.2 Swollen Joint Counts | Standard Error 0.55 |
| SUNPG1623 Dose III | Change From Baseline in Swollen Joint Counts | Week 4 | -3.8 Swollen Joint Counts | Standard Error 0.56 |
| SUNPG1623 Dose IV | Change From Baseline in Swollen Joint Counts | Week 1 | -2.4 Swollen Joint Counts | Standard Error 0.51 |
| SUNPG1623 Dose IV | Change From Baseline in Swollen Joint Counts | Week 4 | -3.0 Swollen Joint Counts | Standard Error 0.55 |
| SUNPG1623 Dose IV | Change From Baseline in Swollen Joint Counts | Week 8 | -5.0 Swollen Joint Counts | Standard Error 0.55 |
| SUNPG1623 Dose IV | Change From Baseline in Swollen Joint Counts | Week 12 | -4.8 Swollen Joint Counts | Standard Error 0.55 |
| SUNPG1623 Dose IV | Change From Baseline in Swollen Joint Counts | Week 24 | -7.6 Swollen Joint Counts | Standard Error 0.52 |
| SUNPG1623 Dose IV | Change From Baseline in Swollen Joint Counts | Week 16 | -6.0 Swollen Joint Counts | Standard Error 0.56 |
| SUNPG1623 Dose IV | Change From Baseline in Swollen Joint Counts | Week 20 | -6.8 Swollen Joint Counts | Standard Error 0.56 |
| Placebo | Change From Baseline in Swollen Joint Counts | Week 12 | -4.9 Swollen Joint Counts | Standard Error 0.54 |
| Placebo | Change From Baseline in Swollen Joint Counts | Week 1 | -1.3 Swollen Joint Counts | Standard Error 0.51 |
| Placebo | Change From Baseline in Swollen Joint Counts | Week 4 | -3.1 Swollen Joint Counts | Standard Error 0.55 |
| Placebo | Change From Baseline in Swollen Joint Counts | Week 8 | -4.7 Swollen Joint Counts | Standard Error 0.54 |
| Placebo | Change From Baseline in Swollen Joint Counts | Week 20 | -6.0 Swollen Joint Counts | Standard Error 0.55 |
| Placebo | Change From Baseline in Swollen Joint Counts | Week 16 | -5.2 Swollen Joint Counts | Standard Error 0.55 |
| Placebo | Change From Baseline in Swollen Joint Counts | Week 24 | -6.5 Swollen Joint Counts | Standard Error 0.51 |
p-value: 0.019Cochran-Mantel-Haenszel
p-value: 0.1282Cochran-Mantel-Haenszel
p-value: 0.0111Cochran-Mantel-Haenszel
p-value: 0.0774Cochran-Mantel-Haenszel
Secondary
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.
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| SUNPG1623 I | Change From Baseline in Tender Joint Counts | Week 8 | -7.1 tender joint counts | Standard Error 0.94 |
| SUNPG1623 I | Change From Baseline in Tender Joint Counts | Week 1 | -1.5 tender joint counts | Standard Error 0.77 |
| SUNPG1623 I | Change From Baseline in Tender Joint Counts | Week 20 | -11.2 tender joint counts | Standard Error 1.09 |
| SUNPG1623 I | Change From Baseline in Tender Joint Counts | Week 16 | -10.3 tender joint counts | Standard Error 1.04 |
| SUNPG1623 I | Change From Baseline in Tender Joint Counts | Week 24 | -11.9 tender joint counts | Standard Error 1.04 |
| SUNPG1623 I | Change From Baseline in Tender Joint Counts | Week 4 | -4.7 tender joint counts | Standard Error 0.89 |
| SUNPG1623 I | Change From Baseline in Tender Joint Counts | Week 12 | -8.3 tender joint counts | Standard Error 0.96 |
| SUNPG1623 II | Change From Baseline in Tender Joint Counts | Week 24 | -12.6 tender joint counts | Standard Error 1.01 |
| SUNPG1623 II | Change From Baseline in Tender Joint Counts | Week 12 | -10.0 tender joint counts | Standard Error 0.94 |
| SUNPG1623 II | Change From Baseline in Tender Joint Counts | Week 1 | -2.4 tender joint counts | Standard Error 0.76 |
| SUNPG1623 II | Change From Baseline in Tender Joint Counts | Week 16 | -11.3 tender joint counts | Standard Error 1.01 |
| SUNPG1623 II | Change From Baseline in Tender Joint Counts | Week 8 | -7.8 tender joint counts | Standard Error 0.92 |
| SUNPG1623 II | Change From Baseline in Tender Joint Counts | Week 20 | -12.3 tender joint counts | Standard Error 1.06 |
| SUNPG1623 II | Change From Baseline in Tender Joint Counts | Week 4 | -4.9 tender joint counts | Standard Error 0.88 |
| SUNPG1623 Dose III | Change From Baseline in Tender Joint Counts | Week 16 | -10.7 tender joint counts | Standard Error 1.03 |
| SUNPG1623 Dose III | Change From Baseline in Tender Joint Counts | Week 20 | -11.5 tender joint counts | Standard Error 1.07 |
| SUNPG1623 Dose III | Change From Baseline in Tender Joint Counts | Week 24 | -12.9 tender joint counts | Standard Error 1.03 |
| SUNPG1623 Dose III | Change From Baseline in Tender Joint Counts | Week 1 | -2.5 tender joint counts | Standard Error 0.78 |
| SUNPG1623 Dose III | Change From Baseline in Tender Joint Counts | Week 4 | -5.4 tender joint counts | Standard Error 0.89 |
| SUNPG1623 Dose III | Change From Baseline in Tender Joint Counts | Week 8 | -8.6 tender joint counts | Standard Error 0.94 |
| SUNPG1623 Dose III | Change From Baseline in Tender Joint Counts | Week 12 | -8.7 tender joint counts | Standard Error 0.95 |
| SUNPG1623 Dose IV | Change From Baseline in Tender Joint Counts | Week 8 | -7.2 tender joint counts | Standard Error 0.93 |
| SUNPG1623 Dose IV | Change From Baseline in Tender Joint Counts | Week 16 | -9.8 tender joint counts | Standard Error 1.04 |
| SUNPG1623 Dose IV | Change From Baseline in Tender Joint Counts | Week 12 | -7.8 tender joint counts | Standard Error 0.96 |
| SUNPG1623 Dose IV | Change From Baseline in Tender Joint Counts | Week 4 | -3.9 tender joint counts | Standard Error 0.88 |
| SUNPG1623 Dose IV | Change From Baseline in Tender Joint Counts | Week 1 | -3.1 tender joint counts | Standard Error 0.76 |
| SUNPG1623 Dose IV | Change From Baseline in Tender Joint Counts | Week 24 | -12.0 tender joint counts | Standard Error 1.04 |
| SUNPG1623 Dose IV | Change From Baseline in Tender Joint Counts | Week 20 | -11.4 tender joint counts | Standard Error 1.09 |
| Placebo | Change From Baseline in Tender Joint Counts | Week 20 | -9.9 tender joint counts | Standard Error 1.06 |
| Placebo | Change From Baseline in Tender Joint Counts | Week 24 | -9.4 tender joint counts | Standard Error 1.02 |
| Placebo | Change From Baseline in Tender Joint Counts | Week 16 | -8.4 tender joint counts | Standard Error 1.02 |
| Placebo | Change From Baseline in Tender Joint Counts | Week 8 | -6.9 tender joint counts | Standard Error 0.91 |
| Placebo | Change From Baseline in Tender Joint Counts | Week 4 | -4.1 tender joint counts | Standard Error 0.87 |
| Placebo | Change From Baseline in Tender Joint Counts | Week 12 | -7.7 tender joint counts | Standard Error 0.94 |
| Placebo | Change From Baseline in Tender Joint Counts | Week 1 | -2.1 tender joint counts | Standard Error 0.76 |
p-value: 0.085Cochran-Mantel-Haenszel
p-value: 0.0234Cochran-Mantel-Haenszel
p-value: 0.014Cochran-Mantel-Haenszel
p-value: 0.0731Cochran-Mantel-Haenszel
Secondary
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.
Time frame: Week 52
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SUNPG1623 I | Change From Baseline in Tender Joint Counts | -12.3 tender joint counts | Standard Deviation 11.47 |
| SUNPG1623 II | Change From Baseline in Tender Joint Counts | -13.7 tender joint counts | Standard Deviation 11.92 |
| SUNPG1623 Dose III | Change From Baseline in Tender Joint Counts | -16.0 tender joint counts | Standard Deviation 12.83 |
| SUNPG1623 Dose IV | Change From Baseline in Tender Joint Counts | -14.0 tender joint counts | Standard Deviation 10.65 |
| Placebo | Change From Baseline in Tender Joint Counts | -13.9 tender joint counts | Standard Deviation 12.02 |
Secondary
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
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, week 24 and Week 52
Population: Cochran-Mantel-Haenszel Analysis of DAS28-CRP Response Rates up to Week 24 Full Analysis Set.~DAS28-CRP Response Rates up to Week 52-Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SUNPG1623 I | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 16 | 48.72 percentage of participants |
| SUNPG1623 I | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 4 | 20.51 percentage of participants |
| SUNPG1623 I | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 20 | 60.26 percentage of participants |
| SUNPG1623 I | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 24 | 58.97 percentage of participants |
| SUNPG1623 I | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 52 | 85.07 percentage of participants |
| SUNPG1623 I | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 1 | 11.54 percentage of participants |
| SUNPG1623 I | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 8 | 35.90 percentage of participants |
| SUNPG1623 I | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 12 | 38.46 percentage of participants |
| SUNPG1623 II | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 1 | 12.66 percentage of participants |
| SUNPG1623 II | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 8 | 29.11 percentage of participants |
| SUNPG1623 II | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 12 | 40.51 percentage of participants |
| SUNPG1623 II | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 20 | 60.76 percentage of participants |
| SUNPG1623 II | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 4 | 17.72 percentage of participants |
| SUNPG1623 II | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 16 | 48.10 percentage of participants |
| SUNPG1623 II | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 24 | 64.56 percentage of participants |
| SUNPG1623 II | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 52 | 81.25 percentage of participants |
| SUNPG1623 Dose III | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 52 | 76.27 percentage of participants |
| SUNPG1623 Dose III | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 4 | 15.58 percentage of participants |
| SUNPG1623 Dose III | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 24 | 58.44 percentage of participants |
| SUNPG1623 Dose III | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 20 | 37.66 percentage of participants |
| SUNPG1623 Dose III | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 8 | 29.87 percentage of participants |
| SUNPG1623 Dose III | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 12 | 31.17 percentage of participants |
| SUNPG1623 Dose III | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 1 | 10.39 percentage of participants |
| SUNPG1623 Dose III | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 16 | 36.36 percentage of participants |
| SUNPG1623 Dose IV | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 1 | 5.13 percentage of participants |
| SUNPG1623 Dose IV | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 16 | 35.90 percentage of participants |
| SUNPG1623 Dose IV | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 8 | 23.08 percentage of participants |
| SUNPG1623 Dose IV | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 20 | 43.59 percentage of participants |
| SUNPG1623 Dose IV | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 24 | 53.85 percentage of participants |
| SUNPG1623 Dose IV | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 4 | 15.38 percentage of participants |
| SUNPG1623 Dose IV | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 52 | 71.05 percentage of participants |
| SUNPG1623 Dose IV | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 12 | 29.49 percentage of participants |
| Placebo | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 52 | 65.33 percentage of participants |
| Placebo | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 1 | 6.33 percentage of participants |
| Placebo | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 4 | 13.92 percentage of participants |
| Placebo | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 12 | 18.99 percentage of participants |
| Placebo | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 16 | 13.92 percentage of participants |
| Placebo | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 20 | 21.52 percentage of participants |
| Placebo | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 8 | 18.99 percentage of participants |
| Placebo | Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate | Week 24 | 30.38 percentage of participants |
95% CI: [76.54, 93.61]
95% CI: [71.69, 90.81]
95% CI: [65.42, 87.13]
95% CI: [60.86, 81.25]
95% CI: [54.56, 76.1]
Secondary
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.
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
Population: Statistical Analysis (Mixed Model Repeated Measures) of Change From Baseline in ESR (mm/hr) up to Week 24 - (No Imputation) Full Analysis Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| SUNPG1623 I | Erythrocyte Sedimentation Rate | Week 24 | -8.0 mm/hr | Standard Error 1.86 |
| SUNPG1623 I | Erythrocyte Sedimentation Rate | Week 16 | -9.4 mm/hr | Standard Error 1.93 |
| SUNPG1623 I | Erythrocyte Sedimentation Rate | Week 12 | -8.6 mm/hr | Standard Error 1.59 |
| SUNPG1623 I | Erythrocyte Sedimentation Rate | Week 4 | -6.9 mm/hr | Standard Error 1.46 |
| SUNPG1623 I | Erythrocyte Sedimentation Rate | Week 8 | -8.7 mm/hr | Standard Error 1.58 |
| SUNPG1623 I | Erythrocyte Sedimentation Rate | Week 20 | -9.6 mm/hr | Standard Error 1.73 |
| SUNPG1623 I | Erythrocyte Sedimentation Rate | Week 1 | -3.1 mm/hr | Standard Error 1.39 |
| SUNPG1623 II | Erythrocyte Sedimentation Rate | Week 20 | -7.2 mm/hr | Standard Error 1.72 |
| SUNPG1623 II | Erythrocyte Sedimentation Rate | Week 24 | -6.9 mm/hr | Standard Error 1.85 |
| SUNPG1623 II | Erythrocyte Sedimentation Rate | Week 8 | -6.5 mm/hr | Standard Error 1.58 |
| SUNPG1623 II | Erythrocyte Sedimentation Rate | Week 1 | -3.0 mm/hr | Standard Error 1.4 |
| SUNPG1623 II | Erythrocyte Sedimentation Rate | Week 16 | -8.4 mm/hr | Standard Error 1.92 |
| SUNPG1623 II | Erythrocyte Sedimentation Rate | Week 12 | -6.8 mm/hr | Standard Error 1.59 |
| SUNPG1623 II | Erythrocyte Sedimentation Rate | Week 4 | -5.9 mm/hr | Standard Error 1.48 |
| SUNPG1623 Dose III | Erythrocyte Sedimentation Rate | Week 16 | -8.3 mm/hr | Standard Error 1.91 |
| SUNPG1623 Dose III | Erythrocyte Sedimentation Rate | Week 1 | -3.3 mm/hr | Standard Error 1.41 |
| SUNPG1623 Dose III | Erythrocyte Sedimentation Rate | Week 8 | -7.1 mm/hr | Standard Error 1.58 |
| SUNPG1623 Dose III | Erythrocyte Sedimentation Rate | Week 24 | -8.2 mm/hr | Standard Error 1.84 |
| SUNPG1623 Dose III | Erythrocyte Sedimentation Rate | Week 20 | -9.2 mm/hr | Standard Error 1.71 |
| SUNPG1623 Dose III | Erythrocyte Sedimentation Rate | Week 4 | -5.5 mm/hr | Standard Error 1.45 |
| SUNPG1623 Dose III | Erythrocyte Sedimentation Rate | Week 12 | -7.9 mm/hr | Standard Error 1.58 |
| SUNPG1623 Dose IV | Erythrocyte Sedimentation Rate | Week 24 | -8.7 mm/hr | Standard Error 1.89 |
| SUNPG1623 Dose IV | Erythrocyte Sedimentation Rate | Week 4 | -5.6 mm/hr | Standard Error 1.47 |
| SUNPG1623 Dose IV | Erythrocyte Sedimentation Rate | Week 1 | -1.1 mm/hr | Standard Error 1.41 |
| SUNPG1623 Dose IV | Erythrocyte Sedimentation Rate | Week 20 | -8.5 mm/hr | Standard Error 1.76 |
| SUNPG1623 Dose IV | Erythrocyte Sedimentation Rate | Week 8 | -5.5 mm/hr | Standard Error 1.6 |
| SUNPG1623 Dose IV | Erythrocyte Sedimentation Rate | Week 16 | -6.0 mm/hr | Standard Error 1.96 |
| SUNPG1623 Dose IV | Erythrocyte Sedimentation Rate | Week 12 | -6.6 mm/hr | Standard Error 1.62 |
| Placebo | Erythrocyte Sedimentation Rate | Week 8 | -3.6 mm/hr | Standard Error 1.64 |
| Placebo | Erythrocyte Sedimentation Rate | Week 4 | -4.8 mm/hr | Standard Error 1.51 |
| Placebo | Erythrocyte Sedimentation Rate | Week 16 | -3.3 mm/hr | Standard Error 2.02 |
| Placebo | Erythrocyte Sedimentation Rate | Week 20 | -4.4 mm/hr | Standard Error 1.81 |
| Placebo | Erythrocyte Sedimentation Rate | Week 1 | -2.6 mm/hr | Standard Error 1.45 |
| Placebo | Erythrocyte Sedimentation Rate | Week 24 | -2.3 mm/hr | Standard Error 1.95 |
| Placebo | Erythrocyte Sedimentation Rate | Week 12 | -2.3 mm/hr | Standard Error 1.66 |
p-value: 0.0351Cochran-Mantel-Haenszel
p-value: 0.0876Cochran-Mantel-Haenszel
p-value: 0.0269Cochran-Mantel-Haenszel
p-value: 0.0185Cochran-Mantel-Haenszel
Secondary
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
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, and week 24
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| SUNPG1623 I | Health Assessment Questionnaire- Disability Index | Week 20 | -0.3052 score for the disability index | Standard Error 0.05256 |
| SUNPG1623 I | Health Assessment Questionnaire- Disability Index | Week 12 | -0.1310 score for the disability index | Standard Error 0.04601 |
| SUNPG1623 I | Health Assessment Questionnaire- Disability Index | Week 4 | -0.0025 score for the disability index | Standard Error 0.04036 |
| SUNPG1623 I | Health Assessment Questionnaire- Disability Index | Week 1 | -0.0374 score for the disability index | Standard Error 0.03454 |
| SUNPG1623 I | Health Assessment Questionnaire- Disability Index | Week 24 | -0.3013 score for the disability index | Standard Error 0.05196 |
| SUNPG1623 I | Health Assessment Questionnaire- Disability Index | Week 16 | -0.2061 score for the disability index | Standard Error 0.0489 |
| SUNPG1623 I | Health Assessment Questionnaire- Disability Index | Week 8 | -0.1510 score for the disability index | Standard Error 0.04709 |
| SUNPG1623 II | Health Assessment Questionnaire- Disability Index | Week 16 | -0.2448 score for the disability index | Standard Error 0.0479 |
| SUNPG1623 II | Health Assessment Questionnaire- Disability Index | Week 20 | -0.2868 score for the disability index | Standard Error 0.05128 |
| SUNPG1623 II | Health Assessment Questionnaire- Disability Index | Week 8 | -0.1279 score for the disability index | Standard Error 0.04627 |
| SUNPG1623 II | Health Assessment Questionnaire- Disability Index | Week 12 | -0.2140 score for the disability index | Standard Error 0.04507 |
| SUNPG1623 II | Health Assessment Questionnaire- Disability Index | Week 4 | -0.0736 score for the disability index | Standard Error 0.03984 |
| SUNPG1623 II | Health Assessment Questionnaire- Disability Index | Week 1 | -0.0453 score for the disability index | Standard Error 0.03436 |
| SUNPG1623 II | Health Assessment Questionnaire- Disability Index | Week 24 | -0.3314 score for the disability index | Standard Error 0.05054 |
| SUNPG1623 Dose III | Health Assessment Questionnaire- Disability Index | Week 1 | -0.0552 score for the disability index | Standard Error 0.03492 |
| SUNPG1623 Dose III | Health Assessment Questionnaire- Disability Index | Week 8 | -0.2035 score for the disability index | Standard Error 0.04687 |
| SUNPG1623 Dose III | Health Assessment Questionnaire- Disability Index | Week 12 | -0.2090 score for the disability index | Standard Error 0.04555 |
| SUNPG1623 Dose III | Health Assessment Questionnaire- Disability Index | Week 16 | -0.2343 score for the disability index | Standard Error 0.04843 |
| SUNPG1623 Dose III | Health Assessment Questionnaire- Disability Index | Week 20 | -0.2911 score for the disability index | Standard Error 0.05185 |
| SUNPG1623 Dose III | Health Assessment Questionnaire- Disability Index | Week 24 | -0.3337 score for the disability index | Standard Error 0.05128 |
| SUNPG1623 Dose III | Health Assessment Questionnaire- Disability Index | Week 4 | -0.0906 score for the disability index | Standard Error 0.03999 |
| SUNPG1623 Dose IV | Health Assessment Questionnaire- Disability Index | Week 20 | -0.1947 score for the disability index | Standard Error 0.05244 |
| SUNPG1623 Dose IV | Health Assessment Questionnaire- Disability Index | Week 16 | -0.2102 score for the disability index | Standard Error 0.04889 |
| SUNPG1623 Dose IV | Health Assessment Questionnaire- Disability Index | Week 24 | -0.2376 score for the disability index | Standard Error 0.05187 |
| SUNPG1623 Dose IV | Health Assessment Questionnaire- Disability Index | Week 12 | -0.1731 score for the disability index | Standard Error 0.04597 |
| SUNPG1623 Dose IV | Health Assessment Questionnaire- Disability Index | Week 8 | -0.1041 score for the disability index | Standard Error 0.04669 |
| SUNPG1623 Dose IV | Health Assessment Questionnaire- Disability Index | Week 4 | -0.0409 score for the disability index | Standard Error 0.03989 |
| SUNPG1623 Dose IV | Health Assessment Questionnaire- Disability Index | Week 1 | -0.0411 score for the disability index | Standard Error 0.03435 |
| Placebo | Health Assessment Questionnaire- Disability Index | Week 12 | -0.1374 score for the disability index | Standard Error 0.04503 |
| Placebo | Health Assessment Questionnaire- Disability Index | Week 16 | -0.1580 score for the disability index | Standard Error 0.04801 |
| Placebo | Health Assessment Questionnaire- Disability Index | Week 20 | -0.2271 score for the disability index | Standard Error 0.05135 |
| Placebo | Health Assessment Questionnaire- Disability Index | Week 24 | -0.1827 score for the disability index | Standard Error 0.05102 |
| Placebo | Health Assessment Questionnaire- Disability Index | Week 4 | -0.0404 score for the disability index | Standard Error 0.03928 |
| Placebo | Health Assessment Questionnaire- Disability Index | Week 8 | -0.1265 score for the disability index | Standard Error 0.04588 |
| Placebo | Health Assessment Questionnaire- Disability Index | Week 1 | -0.0045 score for the disability index | Standard Error 0.03439 |
p-value: 0.0987Cochran-Mantel-Haenszel
p-value: 0.036Cochran-Mantel-Haenszel
p-value: 0.0346Cochran-Mantel-Haenszel
p-value: 0.4442Cochran-Mantel-Haenszel
Secondary
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: 1. tender joint count ≤1; 2. swollen joint count ≤1; 3. PASI score ≤1 or BSA ≤3%; 4. patient Arthritis Pain (VAS) ≤15 mm; 5. patient's global arthritis assessment (VAS) ≤20 mm; 6. HAQ-DI score ≤0.5; 7. 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
Population: Cochran-Mantel-Haenszel Analysis of MDA Response Rates up to Week 24 (Missing Response = Non-response) Full Analysis Set.~MDA Response Rates up to Week 52- Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SUNPG1623 I | Minimal Disease Activity | Week 24 | 33.33 percentage of participants |
| SUNPG1623 I | Minimal Disease Activity | Week 20 | 17.95 percentage of participants |
| SUNPG1623 I | Minimal Disease Activity | Week 12 | 12.82 percentage of participants |
| SUNPG1623 I | Minimal Disease Activity | Week 1 | 0 percentage of participants |
| SUNPG1623 I | Minimal Disease Activity | Week 16 | 12.82 percentage of participants |
| SUNPG1623 I | Minimal Disease Activity | Week 8 | 3.85 percentage of participants |
| SUNPG1623 I | Minimal Disease Activity | Week 4 | 3.85 percentage of participants |
| SUNPG1623 I | Minimal Disease Activity | week 52 | 56.92 percentage of participants |
| SUNPG1623 II | Minimal Disease Activity | Week 16 | 6.33 percentage of participants |
| SUNPG1623 II | Minimal Disease Activity | Week 1 | 1.27 percentage of participants |
| SUNPG1623 II | Minimal Disease Activity | Week 20 | 15.19 percentage of participants |
| SUNPG1623 II | Minimal Disease Activity | Week 24 | 34.18 percentage of participants |
| SUNPG1623 II | Minimal Disease Activity | week 52 | 64.41 percentage of participants |
| SUNPG1623 II | Minimal Disease Activity | Week 4 | 1.27 percentage of participants |
| SUNPG1623 II | Minimal Disease Activity | Week 8 | 2.53 percentage of participants |
| SUNPG1623 II | Minimal Disease Activity | Week 12 | 8.86 percentage of participants |
| SUNPG1623 Dose III | Minimal Disease Activity | Week 24 | 28.57 percentage of participants |
| SUNPG1623 Dose III | Minimal Disease Activity | week 52 | 45.00 percentage of participants |
| SUNPG1623 Dose III | Minimal Disease Activity | Week 4 | 1.30 percentage of participants |
| SUNPG1623 Dose III | Minimal Disease Activity | Week 16 | 7.79 percentage of participants |
| SUNPG1623 Dose III | Minimal Disease Activity | Week 8 | 2.60 percentage of participants |
| SUNPG1623 Dose III | Minimal Disease Activity | Week 1 | 0 percentage of participants |
| SUNPG1623 Dose III | Minimal Disease Activity | Week 20 | 9.09 percentage of participants |
| SUNPG1623 Dose III | Minimal Disease Activity | Week 12 | 7.79 percentage of participants |
| SUNPG1623 Dose IV | Minimal Disease Activity | Week 4 | 2.56 percentage of participants |
| SUNPG1623 Dose IV | Minimal Disease Activity | Week 24 | 19.23 percentage of participants |
| SUNPG1623 Dose IV | Minimal Disease Activity | Week 1 | 0 percentage of participants |
| SUNPG1623 Dose IV | Minimal Disease Activity | Week 20 | 8.97 percentage of participants |
| SUNPG1623 Dose IV | Minimal Disease Activity | Week 12 | 8.97 percentage of participants |
| SUNPG1623 Dose IV | Minimal Disease Activity | Week 8 | 0 percentage of participants |
| SUNPG1623 Dose IV | Minimal Disease Activity | week 52 | 47.06 percentage of participants |
| SUNPG1623 Dose IV | Minimal Disease Activity | Week 16 | 8.97 percentage of participants |
| Placebo | Minimal Disease Activity | week 52 | 42.03 percentage of participants |
| Placebo | Minimal Disease Activity | Week 12 | 2.53 percentage of participants |
| Placebo | Minimal Disease Activity | Week 20 | 2.53 percentage of participants |
| Placebo | Minimal Disease Activity | Week 4 | 1.27 percentage of participants |
| Placebo | Minimal Disease Activity | Week 1 | 0 percentage of participants |
| Placebo | Minimal Disease Activity | Week 8 | 2.53 percentage of participants |
| Placebo | Minimal Disease Activity | Week 24 | 6.33 percentage of participants |
| Placebo | Minimal Disease Activity | Week 16 | 1.27 percentage of participants |
95% CI: [44.88, 68.96]
95% CI: [52.19, 76.62]
95% CI: [32.41, 57.59]
95% CI: [35.2, 58.92]
95% CI: [30.38, 53.68]
Secondary
Patient's Global Assessment of Disease Activity
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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| SUNPG1623 I | Patient's Global Assessment of Disease Activity | Week 16 | -23.5 scores on a visual analog scale | Standard Error 2.63 |
| SUNPG1623 I | Patient's Global Assessment of Disease Activity | Week 8 | -15.4 scores on a visual analog scale | Standard Error 2.3 |
| SUNPG1623 I | Patient's Global Assessment of Disease Activity | Week 4 | -7.5 scores on a visual analog scale | Standard Error 2.17 |
| SUNPG1623 I | Patient's Global Assessment of Disease Activity | Week 20 | -29.7 scores on a visual analog scale | Standard Error 2.64 |
| SUNPG1623 I | Patient's Global Assessment of Disease Activity | Week 1 | -5.9 scores on a visual analog scale | Standard Error 1.85 |
| SUNPG1623 I | Patient's Global Assessment of Disease Activity | Week 24 | -35.0 scores on a visual analog scale | Standard Error 2.6 |
| SUNPG1623 I | Patient's Global Assessment of Disease Activity | Week 12 | -18.1 scores on a visual analog scale | Standard Error 2.52 |
| SUNPG1623 II | Patient's Global Assessment of Disease Activity | Week 12 | -20.3 scores on a visual analog scale | Standard Error 2.46 |
| SUNPG1623 II | Patient's Global Assessment of Disease Activity | Week 20 | -27.3 scores on a visual analog scale | Standard Error 2.57 |
| SUNPG1623 II | Patient's Global Assessment of Disease Activity | Week 24 | -33.3 scores on a visual analog scale | Standard Error 2.52 |
| SUNPG1623 II | Patient's Global Assessment of Disease Activity | Week 8 | -15.5 scores on a visual analog scale | Standard Error 2.25 |
| SUNPG1623 II | Patient's Global Assessment of Disease Activity | Week 16 | -22.0 scores on a visual analog scale | Standard Error 2.57 |
| SUNPG1623 II | Patient's Global Assessment of Disease Activity | Week 1 | -7.5 scores on a visual analog scale | Standard Error 1.84 |
| SUNPG1623 II | Patient's Global Assessment of Disease Activity | Week 4 | -11.9 scores on a visual analog scale | Standard Error 2.14 |
| SUNPG1623 Dose III | Patient's Global Assessment of Disease Activity | Week 1 | -6.8 scores on a visual analog scale | Standard Error 1.87 |
| SUNPG1623 Dose III | Patient's Global Assessment of Disease Activity | Week 8 | -14.5 scores on a visual analog scale | Standard Error 2.28 |
| SUNPG1623 Dose III | Patient's Global Assessment of Disease Activity | Week 24 | -33.4 scores on a visual analog scale | Standard Error 2.56 |
| SUNPG1623 Dose III | Patient's Global Assessment of Disease Activity | Week 4 | -9.5 scores on a visual analog scale | Standard Error 2.15 |
| SUNPG1623 Dose III | Patient's Global Assessment of Disease Activity | Week 16 | -18.7 scores on a visual analog scale | Standard Error 2.59 |
| SUNPG1623 Dose III | Patient's Global Assessment of Disease Activity | Week 12 | -16.1 scores on a visual analog scale | Standard Error 2.49 |
| SUNPG1623 Dose III | Patient's Global Assessment of Disease Activity | Week 20 | -22.7 scores on a visual analog scale | Standard Error 2.6 |
| SUNPG1623 Dose IV | Patient's Global Assessment of Disease Activity | Week 1 | -6.4 scores on a visual analog scale | Standard Error 1.84 |
| SUNPG1623 Dose IV | Patient's Global Assessment of Disease Activity | Week 4 | -8.8 scores on a visual analog scale | Standard Error 2.14 |
| SUNPG1623 Dose IV | Patient's Global Assessment of Disease Activity | Week 8 | -13.1 scores on a visual analog scale | Standard Error 2.28 |
| SUNPG1623 Dose IV | Patient's Global Assessment of Disease Activity | Week 12 | -16.4 scores on a visual analog scale | Standard Error 2.51 |
| SUNPG1623 Dose IV | Patient's Global Assessment of Disease Activity | Week 16 | -19.4 scores on a visual analog scale | Standard Error 2.63 |
| SUNPG1623 Dose IV | Patient's Global Assessment of Disease Activity | Week 20 | -21.6 scores on a visual analog scale | Standard Error 2.64 |
| SUNPG1623 Dose IV | Patient's Global Assessment of Disease Activity | Week 24 | -30.4 scores on a visual analog scale | Standard Error 2.6 |
| Placebo | Patient's Global Assessment of Disease Activity | Week 24 | -21.7 scores on a visual analog scale | Standard Error 2.54 |
| Placebo | Patient's Global Assessment of Disease Activity | Week 20 | -15.6 scores on a visual analog scale | Standard Error 2.58 |
| Placebo | Patient's Global Assessment of Disease Activity | Week 8 | -10.1 scores on a visual analog scale | Standard Error 2.23 |
| Placebo | Patient's Global Assessment of Disease Activity | Week 4 | -5.9 scores on a visual analog scale | Standard Error 2.11 |
| Placebo | Patient's Global Assessment of Disease Activity | Week 1 | -2.8 scores on a visual analog scale | Standard Error 1.84 |
| Placebo | Patient's Global Assessment of Disease Activity | Week 16 | -13.8 scores on a visual analog scale | Standard Error 2.58 |
| Placebo | Patient's Global Assessment of Disease Activity | Week 12 | -11.2 scores on a visual analog scale | Standard Error 2.46 |
p-value: 0.0003Cochran-Mantel-Haenszel
p-value: 0.0012Cochran-Mantel-Haenszel
p-value: 0.0011Cochran-Mantel-Haenszel
p-value: 0.0167Cochran-Mantel-Haenszel
Secondary
Patient's Pain Assessment
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| SUNPG1623 I | Patient's Pain Assessment | Week 12 | -19.4 scores on a visual analog scale | Standard Error 2.54 |
| SUNPG1623 I | Patient's Pain Assessment | Week 16 | -23.8 scores on a visual analog scale | Standard Error 2.58 |
| SUNPG1623 I | Patient's Pain Assessment | Week 1 | -5.8 scores on a visual analog scale | Standard Error 1.96 |
| SUNPG1623 I | Patient's Pain Assessment | Week 24 | -35.1 scores on a visual analog scale | Standard Error 2.69 |
| SUNPG1623 I | Patient's Pain Assessment | Week 20 | -29.8 scores on a visual analog scale | Standard Error 2.79 |
| SUNPG1623 I | Patient's Pain Assessment | Week 8 | -16.9 scores on a visual analog scale | Standard Error 2.42 |
| SUNPG1623 I | Patient's Pain Assessment | Week 4 | -9.8 scores on a visual analog scale | Standard Error 2.15 |
| SUNPG1623 II | Patient's Pain Assessment | Week 4 | -12.8 scores on a visual analog scale | Standard Error 2.12 |
| SUNPG1623 II | Patient's Pain Assessment | Week 20 | -25.3 scores on a visual analog scale | Standard Error 2.71 |
| SUNPG1623 II | Patient's Pain Assessment | Week 16 | -23.2 scores on a visual analog scale | Standard Error 2.52 |
| SUNPG1623 II | Patient's Pain Assessment | Week 1 | -8.1 scores on a visual analog scale | Standard Error 1.95 |
| SUNPG1623 II | Patient's Pain Assessment | Week 24 | -31.6 scores on a visual analog scale | Standard Error 2.6 |
| SUNPG1623 II | Patient's Pain Assessment | Week 12 | -20.4 scores on a visual analog scale | Standard Error 2.48 |
| SUNPG1623 II | Patient's Pain Assessment | Week 8 | -16.1 scores on a visual analog scale | Standard Error 2.37 |
| SUNPG1623 Dose III | Patient's Pain Assessment | Week 20 | -21.4 scores on a visual analog scale | Standard Error 2.74 |
| SUNPG1623 Dose III | Patient's Pain Assessment | Week 24 | -32.1 scores on a visual analog scale | Standard Error 2.64 |
| SUNPG1623 Dose III | Patient's Pain Assessment | Week 4 | -8.9 scores on a visual analog scale | Standard Error 2.13 |
| SUNPG1623 Dose III | Patient's Pain Assessment | Week 1 | -5.1 scores on a visual analog scale | Standard Error 1.98 |
| SUNPG1623 Dose III | Patient's Pain Assessment | Week 8 | -16.6 scores on a visual analog scale | Standard Error 2.41 |
| SUNPG1623 Dose III | Patient's Pain Assessment | Week 12 | -15.6 scores on a visual analog scale | Standard Error 2.5 |
| SUNPG1623 Dose III | Patient's Pain Assessment | Week 16 | -20.6 scores on a visual analog scale | Standard Error 2.55 |
| SUNPG1623 Dose IV | Patient's Pain Assessment | Week 12 | -14.0 scores on a visual analog scale | Standard Error 2.53 |
| SUNPG1623 Dose IV | Patient's Pain Assessment | Week 20 | -21.4 scores on a visual analog scale | Standard Error 2.78 |
| SUNPG1623 Dose IV | Patient's Pain Assessment | Week 16 | -19.3 scores on a visual analog scale | Standard Error 2.59 |
| SUNPG1623 Dose IV | Patient's Pain Assessment | Week 1 | -5.8 scores on a visual analog scale | Standard Error 1.95 |
| SUNPG1623 Dose IV | Patient's Pain Assessment | Week 4 | -6.4 scores on a visual analog scale | Standard Error 2.12 |
| SUNPG1623 Dose IV | Patient's Pain Assessment | Week 24 | -28.8 scores on a visual analog scale | Standard Error 2.68 |
| SUNPG1623 Dose IV | Patient's Pain Assessment | Week 8 | -11.9 scores on a visual analog scale | Standard Error 2.4 |
| Placebo | Patient's Pain Assessment | Week 24 | -21.5 scores on a visual analog scale | Standard Error 2.63 |
| Placebo | Patient's Pain Assessment | Week 1 | -1.6 scores on a visual analog scale | Standard Error 1.95 |
| Placebo | Patient's Pain Assessment | Week 4 | -3.9 scores on a visual analog scale | Standard Error 2.09 |
| Placebo | Patient's Pain Assessment | Week 8 | -8.5 scores on a visual analog scale | Standard Error 2.35 |
| Placebo | Patient's Pain Assessment | Week 12 | -11.5 scores on a visual analog scale | Standard Error 2.48 |
| Placebo | Patient's Pain Assessment | Week 16 | -12.8 scores on a visual analog scale | Standard Error 2.54 |
| Placebo | Patient's Pain Assessment | Week 20 | -17.1 scores on a visual analog scale | Standard Error 2.72 |
p-value: 0.0003Cochran-Mantel-Haenszel
p-value: 0.0055Cochran-Mantel-Haenszel
p-value: 0.0039Cochran-Mantel-Haenszel
p-value: 0.0487Cochran-Mantel-Haenszel
Secondary
Physician Global Assessment of Disease Activity Visual Analog Scale
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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| SUNPG1623 I | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 1 | -7.8 scores on a visual analog scale | Standard Error 1.69 |
| SUNPG1623 I | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 4 | -14.3 scores on a visual analog scale | Standard Error 2.01 |
| SUNPG1623 I | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 8 | -21.9 scores on a visual analog scale | Standard Error 2.2 |
| SUNPG1623 I | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 12 | -27.9 scores on a visual analog scale | Standard Error 2.22 |
| SUNPG1623 I | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 16 | -31.0 scores on a visual analog scale | Standard Error 2.08 |
| SUNPG1623 I | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 20 | -36.7 scores on a visual analog scale | Standard Error 2.19 |
| SUNPG1623 I | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 24 | -36.5 scores on a visual analog scale | Standard Error 2.15 |
| SUNPG1623 II | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 24 | -38.8 scores on a visual analog scale | Standard Error 2.08 |
| SUNPG1623 II | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 1 | -8.0 scores on a visual analog scale | Standard Error 1.68 |
| SUNPG1623 II | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 16 | -32.1 scores on a visual analog scale | Standard Error 2.03 |
| SUNPG1623 II | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 20 | -36.8 scores on a visual analog scale | Standard Error 2.13 |
| SUNPG1623 II | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 8 | -23.6 scores on a visual analog scale | Standard Error 2.16 |
| SUNPG1623 II | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 12 | -28.7 scores on a visual analog scale | Standard Error 2.17 |
| SUNPG1623 II | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 4 | -15.7 scores on a visual analog scale | Standard Error 1.99 |
| SUNPG1623 Dose III | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 24 | -37.5 scores on a visual analog scale | Standard Error 2.11 |
| SUNPG1623 Dose III | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 12 | -27.6 scores on a visual analog scale | Standard Error 2.19 |
| SUNPG1623 Dose III | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 8 | -23.9 scores on a visual analog scale | Standard Error 2.18 |
| SUNPG1623 Dose III | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 1 | -7.2 scores on a visual analog scale | Standard Error 1.7 |
| SUNPG1623 Dose III | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 16 | -31.7 scores on a visual analog scale | Standard Error 2.05 |
| SUNPG1623 Dose III | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 20 | -31.0 scores on a visual analog scale | Standard Error 2.15 |
| SUNPG1623 Dose III | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 4 | -15.1 scores on a visual analog scale | Standard Error 1.99 |
| SUNPG1623 Dose IV | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 16 | -30.8 scores on a visual analog scale | Standard Error 2.08 |
| SUNPG1623 Dose IV | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 4 | -14.0 scores on a visual analog scale | Standard Error 1.99 |
| SUNPG1623 Dose IV | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 1 | -6.2 scores on a visual analog scale | Standard Error 1.68 |
| SUNPG1623 Dose IV | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 24 | -36.3 scores on a visual analog scale | Standard Error 2.14 |
| SUNPG1623 Dose IV | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 12 | -23.1 scores on a visual analog scale | Standard Error 2.22 |
| SUNPG1623 Dose IV | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 20 | -33.0 scores on a visual analog scale | Standard Error 2.19 |
| SUNPG1623 Dose IV | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 8 | -20.8 scores on a visual analog scale | Standard Error 2.18 |
| Placebo | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 20 | -24.3 scores on a visual analog scale | Standard Error 2.13 |
| Placebo | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 1 | -4.5 scores on a visual analog scale | Standard Error 1.67 |
| Placebo | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 4 | -9.7 scores on a visual analog scale | Standard Error 1.95 |
| Placebo | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 8 | -16.2 scores on a visual analog scale | Standard Error 2.13 |
| Placebo | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 12 | -18.5 scores on a visual analog scale | Standard Error 2.17 |
| Placebo | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 16 | -20.2 scores on a visual analog scale | Standard Error 2.04 |
| Placebo | Physician Global Assessment of Disease Activity Visual Analog Scale | Week 24 | -23.5 scores on a visual analog scale | Standard Error 2.09 |
p-value: <0.0001Cochran-Mantel-Haenszel
p-value: <0.0001Cochran-Mantel-Haenszel
p-value: <0.0001Cochran-Mantel-Haenszel
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
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.
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52
Population: Cochran-Mantel-Haenszel Analysis of ACR50 Response Rates up to Week 24 Full Analysis Set.~ACR50 Response Rates up to Week 52 Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SUNPG1623 I | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 24 | 0.5256 proportion of subjects |
| SUNPG1623 I | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 20 | 0.4487 proportion of subjects |
| SUNPG1623 I | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 1 | 0 proportion of subjects |
| SUNPG1623 I | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 16 | 0.3077 proportion of subjects |
| SUNPG1623 I | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 12 | 0.1795 proportion of subjects |
| SUNPG1623 I | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 8 | 0.1667 proportion of subjects |
| SUNPG1623 I | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | week 52 | 0.7910 proportion of subjects |
| SUNPG1623 I | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 4 | 0.0256 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 1 | 0.0253 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 20 | 0.4177 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 24 | 0.5063 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 4 | 0.0506 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 8 | 0.0759 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 12 | 0.1772 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 16 | 0.2785 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | week 52 | 0.7500 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 20 | 0.2857 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 24 | 0.4545 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 8 | 0.1299 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 1 | 0.0130 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 12 | 0.2078 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | week 52 | 0.7213 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 16 | 0.2727 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 4 | 0.0909 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | week 52 | 0.6800 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 20 | 0.2308 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 1 | 0.0128 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 16 | 0.2051 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 24 | 0.3974 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 4 | 0.0385 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 8 | 0.1410 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 12 | 0.1923 proportion of subjects |
| Placebo | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 8 | 0.0759 proportion of subjects |
| Placebo | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | week 52 | 0.6267 proportion of subjects |
| Placebo | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 24 | 0.2405 proportion of subjects |
| Placebo | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 16 | 0.0506 proportion of subjects |
| Placebo | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 1 | 0 proportion of subjects |
| Placebo | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 4 | 0.0253 proportion of subjects |
| Placebo | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 12 | 0.0633 proportion of subjects |
| Placebo | Proportion of Subjects Achieving American College of Rheumatology50 Response Rate | Week 20 | 0.1646 proportion of subjects |
95% CI: [69.37, 88.84]
95% CI: [64.39, 85.61]
95% CI: [60.88, 83.38]
95% CI: [57.44, 78.56]
95% CI: [51.72, 73.61]
Secondary
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.
Time frame: week 1, week 4, week 8, week 12, week 16, week 20, week 24, and week 52
Population: Cochran-Mantel-Haenszel Analysis of ACR70 Response Rates up to Week 24 Full Analysis Set ACR70 Response Rates up to Week 52 Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SUNPG1623 I | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | week 52 | 0.5821 proportion of subjects |
| SUNPG1623 I | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 8 | 0.0256 proportion of subjects |
| SUNPG1623 I | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 16 | 0.1410 proportion of subjects |
| SUNPG1623 I | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 4 | 0.0128 proportion of subjects |
| SUNPG1623 I | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 1 | 0 proportion of subjects |
| SUNPG1623 I | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 12 | 0.1026 proportion of subjects |
| SUNPG1623 I | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 20 | 0.2051 proportion of subjects |
| SUNPG1623 I | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 24 | 0.2821 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 24 | 0.2911 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 16 | 0.1266 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 20 | 0.2658 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 4 | 0.0127 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 8 | 0.0380 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | week 52 | 0.4844 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 12 | 0.0380 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 1 | 0.0127 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 24 | 0.2208 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 4 | 0 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | week 52 | 0.3934 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 1 | 0 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 8 | 0.0260 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 12 | 0.0649 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 16 | 0.1169 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 20 | 0.1429 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 12 | 0.1026 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 1 | 0 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 8 | 0.0256 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 24 | 0.1667 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 20 | 0.1282 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 4 | 0.0128 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | week 52 | 0.4000 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 16 | 0.0897 proportion of subjects |
| Placebo | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | week 52 | 0.3733 proportion of subjects |
| Placebo | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 1 | 0 proportion of subjects |
| Placebo | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 4 | 0.0127 proportion of subjects |
| Placebo | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 8 | 0.0380 proportion of subjects |
| Placebo | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 16 | 0.0253 proportion of subjects |
| Placebo | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 20 | 0.0380 proportion of subjects |
| Placebo | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 24 | 0.1013 proportion of subjects |
| Placebo | Proportion of Subjects Achieving American College of Rheumatology70 Response Rate | Week 12 | 0.0127 proportion of subjects |
95% CI: [46.4, 70.02]
95% CI: [36.19, 60.68]
95% CI: [27.09, 51.6]
95% CI: [28.91, 51.09]
95% CI: [26.39, 48.28]
Secondary
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.
Time frame: week 52
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SUNPG1623 I | Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate | 0.9254 proportion of subjects |
| SUNPG1623 II | Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate | 0.8906 proportion of subjects |
| SUNPG1623 Dose III | Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate | 0.8667 proportion of subjects |
| SUNPG1623 Dose IV | Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate | 0.8133 proportion of subjects |
| Placebo | Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate | 0.8133 proportion of subjects |
95% CI: [86.24, 98.83]
95% CI: [81.42, 96.71]
95% CI: [78.07, 95.27]
95% CI: [72.52, 90.15]
95% CI: [72.52, 90.15]
Secondary
The Proportion of Subjects Who Require Adjustment of Background Therapy
Time frame: Week 16
Population: Subjects Who Require Adjustment of Background Therapy at Week 16 Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SUNPG1623 I | The Proportion of Subjects Who Require Adjustment of Background Therapy | 0 proportion of subjects |
| SUNPG1623 II | The Proportion of Subjects Who Require Adjustment of Background Therapy | 0.0127 proportion of subjects |
| SUNPG1623 Dose III | The Proportion of Subjects Who Require Adjustment of Background Therapy | 0.0130 proportion of subjects |
| SUNPG1623 Dose IV | The Proportion of Subjects Who Require Adjustment of Background Therapy | 0.0256 proportion of subjects |
| Placebo | The Proportion of Subjects Who Require Adjustment of Background Therapy | 0.0127 proportion of subjects |
95% CI: [0, 3.73]
95% CI: [0, 3.83]
95% CI: [0, 6.07]
95% CI: [0, 3.73]