Rheumatoid Arthritis
Conditions
Brief summary
This study will evaluate the safety and efficacy of SKI-O-703 compared with placebo, in patients with active rheumatoid arthritis (RA) who have had an inadequate response to conventional synthetic disease-modifying agents. Patients will be randomly assigned to one of 4 groups and will receive one of three doses of SKI-O-703 or placebo, administered orally twice daily for 12 weeks.
Interventions
DRUGSKI-O-703
Oral administration, twice per day
DRUGPlacebo
Oral administration, twice per day
Sponsors
Oscotec Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must provide written, signed, informed consent. * Patients must have a diagnosis of Rheumatoid Arthritis (RA) according to American College of Rheumatology (ACR) criteria or the 2010 ACR/European League Against Rheumatism classification, for at least 6 months prior to first administration of study drug. * Patients must have active RA at screening and baseline (Day 1 of the study). * Patients who have active disease despite csDMARD (conventional synthetic disease-modifying antirheumatic drugs) therapy for at least 3 months prior to Day 1 of the study. * Patients must have had an inadequate response to previous anti-TNF⍺ (anti-tumor necrosis factor alpha) biological agent(s) for the treatment of RA and meet the washout period prior to Day 1 of the study.
Exclusion criteria
* Patients receiving oral agents, except for medications listed in inclusion criteria for the treatment of RA. * Patients who have previously received any other or biological agent for the treatment of RA, other than anti-TNF⍺ inhibitor(s). * Patients who have a current or past history of hepatitis B virus (HBV) infection; positive test for hepatitis C virus (HCV) antibody; positive test for human immunodeficiency virus (HIV); history of or concurrent interstitial pneumonia; acute infection requiring oral antibiotics within 2 weeks, or parenteral injection of antibiotics within 4 weeks prior to first administration of the study drug; other serious infection within 6 months prior to first administration of study drug; recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to first administration of the study drug; past or current granulomatous infections or other severe or chronic infection; positive test for tuberculosis (TB) or other evidence of TB. * Patients with uncontrolled diabetes mellitus, or uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg). * Patients with any other inflammatory or rheumatic diseases that could impact the evaluation of the effect of the study drug. * Patients with a history of malignancy within 5 years prior to first administration of the study drug, except completely excised and cured squamous cell carcinoma, carcinoma of the cervix in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma. * New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled cardiac disease or heart attack within 6 months prior to first administration of the study drug. * Female patients who are currently pregnant, breastfeeding or planning to become pregnant or breastfeed within 6 months of the last dose of the study drug. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disease Activity Score | Baseline and Week 12 | Mean change from baseline in disease activity score for 28 joints (DAS28) using hsCRP (high sensitivity C-reactive protein). Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), and high sensitivity C-reactive protein (hsCRP) (milligrams per liter). DAS28 was calculated using following formula: DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(hsCRP+1)\*1.10+1.15. High DAS28-hsCRP value indicates more severe disease activity, by value of \>5.1 indicating relatively high disease activity, whereas value of \<3.2 indicating achieved lower disease activity (no theoretical full range available). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | Baseline and Weeks 2, 4 8 and 12 | ACR50 score is the percentage of patients showing ≥50% improvement from baseline in tender joint count (68 joint counts), ≥50% improvement in swollen joint count (66 joint counts), and ≥50% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein) |
| • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | Baseline and Weeks 2, 4 8 and 12 | ACR70 score is the percentage of patients showing ≥70% improvement from baseline in tender joint count (68 joint counts), ≥70% improvement in swollen joint count (66 joint counts), and ≥70% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein) |
| • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | Baseline and Weeks 2, 4 8 and 12 | ACR20 score is the percentage of patients showing ≥20% improvement from baseline in tender joint count (68 joint counts), ≥20% improvement in swollen joint count (66 joint counts), and ≥20% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein) |
| Adverse Events (AEs) | Up to Week 16 | — |
| Serious Adverse Events (SAEs) | Up to Week 16 | — |
| Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline and Weeks 2, 4 8 and 12 | Change from baseline measured by disability index The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a subject-reported questionnaire that is commonly used to measure the disease associated disability. It consists of 8 sections which are dressing or grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, ranging from 0 (no disability) to 3 (worst disability), higher score showing more disability. A decrease in HAQ-DI score indicated an improvement in the participant's condition. |
Countries
Czechia, Poland, Russia, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: Oral administration, twice per day | 41 |
| SKI-O-703 100 mg SKI-O-703: Oral administration, twice per day | 41 |
| SKI-O-703 200 mg SKI-O-703: Oral administration, twice per day | 40 |
| SKI-O-703 400 mg SKI-O-703: Oral administration, twice per day | 41 |
| Total | 163 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 | 1 |
| Overall Study | Not Specific | 0 | 0 | 1 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 0 | 2 |
Baseline characteristics
| Characteristic | SKI-O-703 100 mg | SKI-O-703 200 mg | Placebo | SKI-O-703 400 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 10.9 | 55.2 years STANDARD_DEVIATION 11.51 | 55.4 years STANDARD_DEVIATION 12.03 | 52.3 years STANDARD_DEVIATION 12.8 | 54.9 years STANDARD_DEVIATION 11.84 |
| Age, Customized Age Category 75 years old or greater | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 5 Participants |
| Age, Customized Age Category Greater than 65 to less than 75 years old | 9 Participants | 9 Participants | 9 Participants | 3 Participants | 30 Participants |
| Age, Customized Age Category Less than 65 years old | 31 Participants | 31 Participants | 30 Participants | 36 Participants | 128 Participants |
| Alcohol history Current drinker | 4 Participants | 11 Participants | 7 Participants | 8 Participants | 30 Participants |
| Alcohol history Never a drinker | 34 Participants | 27 Participants | 32 Participants | 31 Participants | 124 Participants |
| Alcohol history Prior drinker, but no longer a drinker | 3 Participants | 2 Participants | 2 Participants | 2 Participants | 9 Participants |
| Body mass index (kg/m^2) | 28.04 kg/m^2 STANDARD_DEVIATION 5.076 | 29.50 kg/m^2 STANDARD_DEVIATION 7.474 | 27.48 kg/m^2 STANDARD_DEVIATION 4.602 | 26.56 kg/m^2 STANDARD_DEVIATION 4.357 | 27.88 kg/m^2 STANDARD_DEVIATION 5.555 |
| Height (cm) | 165.61 centimeter STANDARD_DEVIATION 9.003 | 163.33 centimeter STANDARD_DEVIATION 7.918 | 166.07 centimeter STANDARD_DEVIATION 5.995 | 163.18 centimeter STANDARD_DEVIATION 8.098 | 164.55 centimeter STANDARD_DEVIATION 7.867 |
| Nicotine use Current smoker or user | 5 Participants | 4 Participants | 5 Participants | 8 Participants | 22 Participants |
| Nicotine use Never a smoker or user | 32 Participants | 30 Participants | 34 Participants | 31 Participants | 127 Participants |
| Nicotine use Prior smoker or user | 4 Participants | 6 Participants | 2 Participants | 2 Participants | 14 Participants |
| Race/Ethnicity, Customized Race American-Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Black or African-American | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White | 41 Participants | 37 Participants | 36 Participants | 38 Participants | 152 Participants |
| Sex: Female, Male Female | 29 Participants | 32 Participants | 34 Participants | 33 Participants | 128 Participants |
| Sex: Female, Male Male | 12 Participants | 8 Participants | 7 Participants | 8 Participants | 35 Participants |
| Time since RA onset (years) | 6.86 years STANDARD_DEVIATION 5.587 | 6.12 years STANDARD_DEVIATION 5.578 | 9.05 years STANDARD_DEVIATION 6.418 | 8.83 years STANDARD_DEVIATION 7.26 | 7.72 years STANDARD_DEVIATION 6.321 |
| Weight (kg) | 77.09 kilogram STANDARD_DEVIATION 16.243 | 78.71 kilogram STANDARD_DEVIATION 20.177 | 75.68 kilogram STANDARD_DEVIATION 12.59 | 70.83 kilogram STANDARD_DEVIATION 13.372 | 75.56 kilogram STANDARD_DEVIATION 15.973 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 41 | 0 / 40 | 0 / 41 |
| other Total, other adverse events | 8 / 41 | 6 / 41 | 10 / 40 | 13 / 41 |
| serious Total, serious adverse events | 1 / 41 | 1 / 41 | 0 / 40 | 1 / 41 |
Outcome results
Primary
Change in Disease Activity Score
Mean change from baseline in disease activity score for 28 joints (DAS28) using hsCRP (high sensitivity C-reactive protein). Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), and high sensitivity C-reactive protein (hsCRP) (milligrams per liter). DAS28 was calculated using following formula: DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(hsCRP+1)\*1.10+1.15. High DAS28-hsCRP value indicates more severe disease activity, by value of \>5.1 indicating relatively high disease activity, whereas value of \<3.2 indicating achieved lower disease activity (no theoretical full range available).
Time frame: Baseline and Week 12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Disease Activity Score | -0.95 score on a scale | Standard Error 0.152 |
| SKI-O-703 100 mg | Change in Disease Activity Score | -0.91 score on a scale | Standard Error 0.155 |
| SKI-O-703 200 mg | Change in Disease Activity Score | -1.06 score on a scale | Standard Error 0.155 |
| SKI-O-703 400 mg | Change in Disease Activity Score | -1.15 score on a scale | Standard Error 0.155 |
Secondary
Adverse Events (AEs)
Time frame: Up to Week 16
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Adverse Events (AEs) | Participants with any Treatment Emergent Adverse Event (TEAE) | 19 Participants |
| Placebo | Adverse Events (AEs) | Participants with any treatment-related TEAE | 8 Participants |
| SKI-O-703 100 mg | Adverse Events (AEs) | Participants with any treatment-related TEAE | 4 Participants |
| SKI-O-703 100 mg | Adverse Events (AEs) | Participants with any Treatment Emergent Adverse Event (TEAE) | 16 Participants |
| SKI-O-703 200 mg | Adverse Events (AEs) | Participants with any Treatment Emergent Adverse Event (TEAE) | 23 Participants |
| SKI-O-703 200 mg | Adverse Events (AEs) | Participants with any treatment-related TEAE | 12 Participants |
| SKI-O-703 400 mg | Adverse Events (AEs) | Participants with any Treatment Emergent Adverse Event (TEAE) | 25 Participants |
| SKI-O-703 400 mg | Adverse Events (AEs) | Participants with any treatment-related TEAE | 14 Participants |
Secondary
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Change from baseline measured by disability index The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a subject-reported questionnaire that is commonly used to measure the disease associated disability. It consists of 8 sections which are dressing or grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, ranging from 0 (no disability) to 3 (worst disability), higher score showing more disability. A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Time frame: Baseline and Weeks 2, 4 8 and 12
Population: The number analyzed in some rows decreased as weeks increased, as some patients withdrew from the study or had missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Change from Baseline at Week 12 | -0.4459 score on a scale | Standard Deviation 0.4765 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Change from Baseline at Week 8 | -0.3816 score on a scale | Standard Deviation 0.4171 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Change from Baseline at Week 2 | -0.0969 score on a scale | Standard Deviation 0.3171 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Change from Baseline at Week 4 | -0.2179 score on a scale | Standard Deviation 0.3228 |
| SKI-O-703 100 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Change from Baseline at Week 4 | -0.2906 score on a scale | Standard Deviation 0.3494 |
| SKI-O-703 100 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Change from Baseline at Week 2 | -0.1375 score on a scale | Standard Deviation 0.2953 |
| SKI-O-703 100 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Change from Baseline at Week 8 | -0.3781 score on a scale | Standard Deviation 0.3968 |
| SKI-O-703 100 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Change from Baseline at Week 12 | -0.5208 score on a scale | Standard Deviation 0.4758 |
| SKI-O-703 200 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Change from Baseline at Week 8 | -0.3311 score on a scale | Standard Deviation 0.4362 |
| SKI-O-703 200 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Change from Baseline at Week 12 | -0.4444 score on a scale | Standard Deviation 0.504 |
| SKI-O-703 200 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Change from Baseline at Week 4 | -0.2895 score on a scale | Standard Deviation 0.2979 |
| SKI-O-703 200 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Change from Baseline at Week 2 | -0.2340 score on a scale | Standard Deviation 0.3037 |
| SKI-O-703 400 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Change from Baseline at Week 12 | -0.4514 score on a scale | Standard Deviation 0.5246 |
| SKI-O-703 400 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Change from Baseline at Week 2 | -0.3397 score on a scale | Standard Deviation 0.4035 |
| SKI-O-703 400 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Change from Baseline at Week 4 | -0.3718 score on a scale | Standard Deviation 0.4646 |
| SKI-O-703 400 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Change from Baseline at Week 8 | -0.4306 score on a scale | Standard Deviation 0.504 |
Secondary
• Percentage of Patients With ACR20 (American College of Rheumatology 20) Score
ACR20 score is the percentage of patients showing ≥20% improvement from baseline in tender joint count (68 joint counts), ≥20% improvement in swollen joint count (66 joint counts), and ≥20% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)
Time frame: Baseline and Weeks 2, 4 8 and 12
Population: The number analyzed in some rows decreased as weeks increased, as some patients withdrew from the study or had missing data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | Week 2 | 2 Participants |
| Placebo | • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | Week 4 | 7 Participants |
| Placebo | • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | Week 8 | 10 Participants |
| Placebo | • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | Week 12 | 12 Participants |
| SKI-O-703 100 mg | • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | Week 4 | 4 Participants |
| SKI-O-703 100 mg | • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | Week 8 | 9 Participants |
| SKI-O-703 100 mg | • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | Week 12 | 9 Participants |
| SKI-O-703 100 mg | • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | Week 2 | 3 Participants |
| SKI-O-703 200 mg | • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | Week 8 | 9 Participants |
| SKI-O-703 200 mg | • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | Week 4 | 6 Participants |
| SKI-O-703 200 mg | • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | Week 12 | 14 Participants |
| SKI-O-703 200 mg | • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | Week 2 | 5 Participants |
| SKI-O-703 400 mg | • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | Week 12 | 9 Participants |
| SKI-O-703 400 mg | • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | Week 4 | 9 Participants |
| SKI-O-703 400 mg | • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | Week 2 | 5 Participants |
| SKI-O-703 400 mg | • Percentage of Patients With ACR20 (American College of Rheumatology 20) Score | Week 8 | 7 Participants |
Secondary
• Percentage of Patients With ACR50 (American College of Rheumatology 50) Score
ACR50 score is the percentage of patients showing ≥50% improvement from baseline in tender joint count (68 joint counts), ≥50% improvement in swollen joint count (66 joint counts), and ≥50% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)
Time frame: Baseline and Weeks 2, 4 8 and 12
Population: The number analyzed in some rows decreased as weeks increased, as some patients withdrew from the study or had missing data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | Week 12 | 4 Participants |
| Placebo | • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | Week 8 | 3 Participants |
| Placebo | • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | Week 2 | 0 Participants |
| Placebo | • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | Week 4 | 2 Participants |
| SKI-O-703 100 mg | • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | Week 4 | 2 Participants |
| SKI-O-703 100 mg | • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | Week 2 | 0 Participants |
| SKI-O-703 100 mg | • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | Week 8 | 4 Participants |
| SKI-O-703 100 mg | • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | Week 12 | 4 Participants |
| SKI-O-703 200 mg | • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | Week 8 | 4 Participants |
| SKI-O-703 200 mg | • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | Week 12 | 6 Participants |
| SKI-O-703 200 mg | • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | Week 4 | 1 Participants |
| SKI-O-703 200 mg | • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | Week 2 | 0 Participants |
| SKI-O-703 400 mg | • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | Week 12 | 5 Participants |
| SKI-O-703 400 mg | • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | Week 2 | 2 Participants |
| SKI-O-703 400 mg | • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | Week 4 | 6 Participants |
| SKI-O-703 400 mg | • Percentage of Patients With ACR50 (American College of Rheumatology 50) Score | Week 8 | 5 Participants |
Secondary
• Percentage of Patients With ACR70 (American College of Rheumatology 70) Score
ACR70 score is the percentage of patients showing ≥70% improvement from baseline in tender joint count (68 joint counts), ≥70% improvement in swollen joint count (66 joint counts), and ≥70% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)
Time frame: Baseline and Weeks 2, 4 8 and 12
Population: The number analyzed in some rows decreased as weeks increased, as some patients withdrew from the study or had missing data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | Week 12 | 1 Participants |
| Placebo | • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | Week 8 | 0 Participants |
| Placebo | • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | Week 2 | 0 Participants |
| Placebo | • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | Week 4 | 0 Participants |
| SKI-O-703 100 mg | • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | Week 4 | 0 Participants |
| SKI-O-703 100 mg | • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | Week 2 | 0 Participants |
| SKI-O-703 100 mg | • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | Week 8 | 0 Participants |
| SKI-O-703 100 mg | • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | Week 12 | 0 Participants |
| SKI-O-703 200 mg | • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | Week 8 | 2 Participants |
| SKI-O-703 200 mg | • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | Week 12 | 3 Participants |
| SKI-O-703 200 mg | • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | Week 4 | 0 Participants |
| SKI-O-703 200 mg | • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | Week 2 | 0 Participants |
| SKI-O-703 400 mg | • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | Week 12 | 3 Participants |
| SKI-O-703 400 mg | • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | Week 2 | 1 Participants |
| SKI-O-703 400 mg | • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | Week 4 | 1 Participants |
| SKI-O-703 400 mg | • Percentage of Patients With ACR70 (American College of Rheumatology 70) Score | Week 8 | 3 Participants |
Secondary
Serious Adverse Events (SAEs)
Time frame: Up to Week 16
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Serious Adverse Events (SAEs) | Participants with any treatment-emergent SAE | 1 Participants |
| Placebo | Serious Adverse Events (SAEs) | Participants with any treatment-related, treatment-emergent SAE | 0 Participants |
| SKI-O-703 100 mg | Serious Adverse Events (SAEs) | Participants with any treatment-related, treatment-emergent SAE | 0 Participants |
| SKI-O-703 100 mg | Serious Adverse Events (SAEs) | Participants with any treatment-emergent SAE | 1 Participants |
| SKI-O-703 200 mg | Serious Adverse Events (SAEs) | Participants with any treatment-emergent SAE | 0 Participants |
| SKI-O-703 200 mg | Serious Adverse Events (SAEs) | Participants with any treatment-related, treatment-emergent SAE | 0 Participants |
| SKI-O-703 400 mg | Serious Adverse Events (SAEs) | Participants with any treatment-emergent SAE | 1 Participants |
| SKI-O-703 400 mg | Serious Adverse Events (SAEs) | Participants with any treatment-related, treatment-emergent SAE | 0 Participants |