Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid arthritis
Brief summary
This was a randomized, double blind, placebo controlled, dose ranging, parallel group study. Participants who had active rheumatoid arthritis (RA) who had inadequate response to any disease modifying anti-rheumatic drug (DMARD) therapy including biologics were enrolled. Screening evaluations were performed within approximately 28 days of randomization. The duration of the study was 6 months with the primary endpoint assessed at 3 months. Eligible participants were randomly assigned to one of three doses (4, 7 or 10 mg QD) of INCB028050 (Baricitinib) or placebo.
Interventions
DRUGINCB028050
4 mg capsules QD
DRUGPlacebo
Placebo matching INCB028050 QD
Sponsors
Incyte Corporation
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
* Must have rheumatoid arthritis which has been inadequately controlled with at least one DMARD * For subjects receiving antimalarials, they must be treated with antimalarials for at least 6 months and receiving a stable daily dose * For subjects receiving sulfasalazine, they must be treated with Sulfasalazine (SSZ) for at least 6 months and receiving a stable daily dose of no more than 3 grams per day * For subjects on methotrexate, they must be treated with methotrexate for at least 6 months, and receiving a stable weekly dose of methotrexate between 7.5 and 25 mg * For subjects on leflunomide, they must be treated with leflunomide for at least 6 months, and receiving a stable dose of leflunomide between 10 to 20 mg * For subjects receiving corticosteroids, they must be on a dose not to exceed 10 mg of prednisone daily * Active rheumatoid arthritis at the time of screening defined by the following: 6 or more joints tender or painful on motion and 4 or more swollen joints and at least one of the following two: Erythrocyte sedimentation rate (ESR) greater than or equal to 28 mm/hr or C-reactive protein (CRP) greater than or equal to 7 mg/liter * Have evidence of lack of risk for tuberculosis
Exclusion criteria
* Current or recent viral, bacterial, fungal, parasitic or mycobacterial infection requiring systemic therapy * History of infected joint prosthesis * Subjects who have a current or recent history of severe, progressive, uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease * Subjects who have received treatment with the following drugs or drug classes within the specified timeframe: prior treatment with rituximab within 12 months, prior treatment with an oral Janus kinase (JAK) inhibitor, DMARDs or other anti-rheumatic therapies not specified and allowed according to protocol, treatment with any investigational medication within 12 weeks or 5 half-lives (whichever is longer), and treatment with a biologic agent within 12 weeks prior to the first dose of study medication * Subjects with a past history of neutropenia, thrombocytopenia or anemia requiring transfusion other than at the time of trauma or surgery, and subjects that meet protocol specified laboratory measures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement | Week 12 | The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: participants' assessment of pain, participants' global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), participants' self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change. |
| Participants With at Least 1 Adverse Event From Baseline Through Week 12 | From Baseline through week 12 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24 | Week 12 and Week 24 | The ACR 50 is defined as ≥ 50% improvement in tender joint count plus ≥ 50% improvement in swollen joint count plus ≥50% improvement in 3 of the following 5 criteria: participants' assessment of pain, PGA, PHGA, participants' self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change. |
| The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24 | Week 12 and Week 24 | The ACR 70 is defined as ≥ 70% improvement in tender joint count plus ≥ 70% improvement in swollen joint count plus ≥ 70% improvement in 3 of the following 5 criteria: participants' assessment of pain, PGA, PHGA, participants' self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change. |
| The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24 | Week 12 and Week 24 | The ACR 90 is defined greater than or equal to (\>=) 90 percent (%) improvement in painful and tender joint count; \>= 90% improvement in swollen joint count; and \>= 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP) at each visit. |
| Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus C-reactive protein (CRP). A higher score indicated more disease activity. The mean change from baseline (which represent decreases in the DAS 28 CRP scores) are shown as positive numbers in these analyses. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (\>5.1=high disease activity; \<3.2=low disease activity; \<2.6=remission). |
| Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus Erythrocyte sedimentation rate (ESR). The DAS28-ESR is expressed as units on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR \<2.6. The mean change from baseline (which represent decreases in the DAS 28 ESR scores) are shown as positive numbers in these analyses. |
| Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2 | Week 12 and Week 24 | Participants who achieved low disease activity based on the DAS 28 ESR (score ≤3.2). Participants who achieved low disease activity were classified as responders in this analysis. |
| Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6 | Week 12 and Week 24 | Participants who achieved inactive disease based on the DAS 28 ESR (score ≤2.6). Participants who achieved low disease activity were classified as responders in this analysis. |
| Percentage of Participants Achieving Remission by DAS28 (CRP) ≤2.6 | Week 12 and Week 24 | Participants who achieved inactive disease based on DAS 28 CRP (score ≤2.6). Participants who achieved low disease activity were classified as responders in this analysis. |
| Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24 | Baseline, Week 12 and Week 24 | The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status. |
| Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24 | Baseline, Week 12 and Week 24 | The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status. |
| Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | Participants were to assess their current level of pain on a 100 mm horizontal Visual Analog Scale (VAS). The left-hand extreme of the line (0 mm) was described as no pain and the right-hand (100 mm) as most imaginable pain. |
| Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | Participants were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no arthritis activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as extremely active arthritis (maximum arthritis disease activity). A decreasing mean score, therefore, indicates improvement. |
| Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | Physicians were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no arthritis activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as extremely active arthritis (maximum arthritis disease activity). A decreasing mean score, therefore, indicates improvement. |
| Participants With at Least 1 Adverse Event From Week 12 to Week 24 | Week 12 to Week 24 | — |
| Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation. |
| Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. |
| Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). |
| Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response (DAS28 ESR) at Week 12 | Week 12 | EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. |
| Percentage of Participants Achieving Good EULAR Response (DAS28ESR) at Week 24 | Week 24 | EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. |
| Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 12 | Week 12 | EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 2.6. |
| Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 24 | Week 24 | EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 2.6. |
| Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best). |
| Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best). |
| Percent of Participants Achieving a Minimum Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 and Week 24 | Week 12 and Week 24 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. The MCID score for HAQ-DI is -0.22. |
| Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24 | Week 12 and Week 24 | Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no pain and the right-hand (100 mm) as most imaginable pain. MCID for the pain score is a decrease of at least 10 mm on a 100 mm scale. |
| Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 | Week 12 and Week 24 | The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best). |
| Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. |
| The Percentage of Participants Who Were Assigned to Active Treatment at Baseline Achieving ACR 20 Improvement at Week 24 | From Baseline to Week 24 | The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: participants' assessment of pain, participants' global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), participants' self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change. |
Countries
Czechia, United States
Participant flow
Recruitment details
The study population included participants diagnosed with RA who had failed to respond adequately to any DMARD therapy, including biologics.
Pre-assignment details
The study was divided into 3 distinct phases: Screening Phase (up to 28 days before randomization), Treatment Phase (12 weeks + 12-week extension period), and the Follow-up (4 ± 1 weeks following final dose of study medication).
Participants by arm
| Arm | Count |
|---|---|
| INCB028050 4 mg QD INCB028050 was administered qd, orally in 4 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time. | 32 |
| INCB028050 7 mg QD INCB028050 was administered qd, orally in 7 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time. | 32 |
| INCB028050 10 mg QD INCB028050 was administered qd, orally in 10 mg capsules. All participants were treated with only 1 capsule daily, without regard to meal time. | 32 |
| Placebo INCB028050 was administered qd, orally in matching placebo capsules. All participants were treated with only 1 capsule daily, without regard to meal time. | 31 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Extension Period (Weeks 12 Through 24) | Adverse Event | 0 | 0 | 0 | 0 | 1 | 2 |
| Extension Period (Weeks 12 Through 24) | Consent Withdrawn | 0 | 0 | 1 | 1 | 0 | 0 |
| Extension Period (Weeks 12 Through 24) | Disease Progression | 0 | 0 | 0 | 1 | 0 | 0 |
| Extension Period (Weeks 12 Through 24) | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 |
| Extension Period (Weeks 12 Through 24) | Protocol Deviation | 0 | 0 | 0 | 0 | 0 | 1 |
| Follow-up (After Week 24) | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 |
| Treatment Period (Weeks 0 Through 12) | Adverse Event | 1 | 0 | 0 | 1 | 1 | 2 |
| Treatment Period (Weeks 0 Through 12) | Consent Withdrawn | 1 | 0 | 0 | 0 | 0 | 2 |
| Treatment Period (Weeks 0 Through 12) | corrected QT (QTc) exclusion criteria | 0 | 0 | 0 | 1 | 0 | 0 |
| Treatment Period (Weeks 0 Through 12) | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 |
| Treatment Period (Weeks 0 Through 12) | Protocol Deviation | 0 | 0 | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | INCB028050 4 mg QD | INCB028050 7 mg QD | INCB028050 10 mg QD | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 12.28 | 53.7 years STANDARD_DEVIATION 10.92 | 57.3 years STANDARD_DEVIATION 10.38 | 55.2 years STANDARD_DEVIATION 10.09 | 55.8 years STANDARD_DEVIATION 10.92 |
| Sex: Female, Male Female | 29 Participants | 26 Participants | 25 Participants | 22 Participants | 102 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 7 Participants | 9 Participants | 25 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 23 / 31 | 19 / 31 | 15 / 32 | 20 / 31 | 11 / 14 | 9 / 15 | 11 / 29 | 17 / 30 | 6 / 27 | 0 / 14 | 1 / 15 | 3 / 29 | 5 / 30 | 2 / 27 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 | 1 / 32 | 0 / 31 | 0 / 14 | 0 / 15 | 0 / 29 | 1 / 30 | 0 / 27 | 0 / 14 | 1 / 15 | 0 / 29 | 0 / 30 | 0 / 27 |
Outcome results
Primary
Participants With at Least 1 Adverse Event From Baseline Through Week 12
Time frame: From Baseline through week 12
Population: Safety Evaluable Participants included all participants who were enrolled and took at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Participants With at Least 1 Adverse Event From Baseline Through Week 12 | 19 Participants |
| INCB028050 4 mg QD | Participants With at Least 1 Adverse Event From Baseline Through Week 12 | 15 Participants |
| INCB028050 7 mg QD | Participants With at Least 1 Adverse Event From Baseline Through Week 12 | 20 Participants |
| INCB028050 10 mg QD | Participants With at Least 1 Adverse Event From Baseline Through Week 12 | 23 Participants |
Primary
The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement
The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: participants' assessment of pain, participants' global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), participants' self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.
Time frame: Week 12
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement | 10 Participants |
| INCB028050 4 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement | 16 Participants |
| INCB028050 7 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement | 19 Participants |
| INCB028050 10 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement | 16 Participants |
Comparison: The prespecified primary analysis for ACR 20 was the Cochran-Armitage trend test looking for a dose-response relationship. The treatment effect was also assessed using a logistic regression model including background therapy (more than 8 weeks of biologics or not) and treatment.p-value: 0.061995% CI: [0.77, 6.15]Cochran-Armitage trend test
Comparison: Sensitivity analysis for pairwise comparisons of 4 mg QD versus placebo.p-value: 0.1978Fisher Exact
Comparison: Sensitivity analysis for pairwise comparisons of 7 mg QD versus placebo.p-value: 0.0437Fisher Exact
Comparison: Sensitivity analysis for pairwise comparisons of 10 mg QD versus placebo.p-value: 0.1236Fisher Exact
Secondary
Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24
The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.
Time frame: Baseline, Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24 | Baseline | 11.0 Swollen joints | Standard Deviation 5.28 |
| Placebo | Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24 | Change from baseline at Week 24 | NA Swollen joints | — |
| Placebo | Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24 | Change from baseline at Week 12 | -3.7 Swollen joints | Standard Deviation 4.02 |
| INCB028050 4 mg QD | Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24 | Baseline | 12.0 Swollen joints | Standard Deviation 5.48 |
| INCB028050 4 mg QD | Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24 | Change from baseline at Week 24 | -7.3 Swollen joints | Standard Deviation 5.14 |
| INCB028050 4 mg QD | Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24 | Change from baseline at Week 12 | -6.1 Swollen joints | Standard Deviation 4.43 |
| INCB028050 7 mg QD | Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24 | Change from baseline at Week 12 | -5.4 Swollen joints | Standard Deviation 5.85 |
| INCB028050 7 mg QD | Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24 | Baseline | 10.6 Swollen joints | Standard Deviation 4.57 |
| INCB028050 7 mg QD | Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24 | Change from baseline at Week 24 | -6.2 Swollen joints | Standard Deviation 5.04 |
| INCB028050 10 mg QD | Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24 | Baseline | 12.9 Swollen joints | Standard Deviation 5.12 |
| INCB028050 10 mg QD | Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24 | Change from baseline at Week 24 | -9.1 Swollen joints | Standard Deviation 5.1 |
| INCB028050 10 mg QD | Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24 | Change from baseline at Week 12 | -7.2 Swollen joints | Standard Deviation 5.57 |
Secondary
Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24
The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.
Time frame: Baseline, Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24 | Baseline | 15.9 Tender joints | Standard Deviation 6.67 |
| Placebo | Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24 | Change from baseline at Week 24 | NA Tender joints | — |
| Placebo | Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24 | Change from baseline at Week 12 | -5.3 Tender joints | Standard Deviation 6.4 |
| INCB028050 4 mg QD | Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24 | Baseline | 14.4 Tender joints | Standard Deviation 6.58 |
| INCB028050 4 mg QD | Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24 | Change from baseline at Week 24 | -8.3 Tender joints | Standard Deviation 6.17 |
| INCB028050 4 mg QD | Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24 | Change from baseline at Week 12 | -7.4 Tender joints | Standard Deviation 6.21 |
| INCB028050 7 mg QD | Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24 | Change from baseline at Week 12 | -6.4 Tender joints | Standard Deviation 7.98 |
| INCB028050 7 mg QD | Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24 | Baseline | 14.7 Tender joints | Standard Deviation 6.7 |
| INCB028050 7 mg QD | Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24 | Change from baseline at Week 24 | -8.7 Tender joints | Standard Deviation 7.42 |
| INCB028050 10 mg QD | Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24 | Baseline | 15.9 Tender joints | Standard Deviation 6.37 |
| INCB028050 10 mg QD | Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24 | Change from baseline at Week 24 | -12.0 Tender joints | Standard Deviation 8.19 |
| INCB028050 10 mg QD | Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24 | Change from baseline at Week 12 | -8.8 Tender joints | Standard Deviation 8.86 |
Secondary
Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24 | Baseline | 10.89 mg/L | Standard Deviation 11.556 |
| Placebo | Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | NA mg/L | — |
| Placebo | Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | 0.18 mg/L | Standard Deviation 10.063 |
| INCB028050 4 mg QD | Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24 | Baseline | 15.63 mg/L | Standard Deviation 17.327 |
| INCB028050 4 mg QD | Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -9.76 mg/L | Standard Deviation 16.053 |
| INCB028050 4 mg QD | Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -6.74 mg/L | Standard Deviation 18.086 |
| INCB028050 7 mg QD | Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -4.01 mg/L | Standard Deviation 26.799 |
| INCB028050 7 mg QD | Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24 | Baseline | 15.64 mg/L | Standard Deviation 16.113 |
| INCB028050 7 mg QD | Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -7.90 mg/L | Standard Deviation 16.713 |
| INCB028050 10 mg QD | Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -5.52 mg/L | Standard Deviation 9.017 |
| INCB028050 10 mg QD | Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24 | Baseline | 7.52 mg/L | Standard Deviation 8.581 |
| INCB028050 10 mg QD | Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -0.73 mg/L | Standard Deviation 13.488 |
Secondary
Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24
Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus C-reactive protein (CRP). A higher score indicated more disease activity. The mean change from baseline (which represent decreases in the DAS 28 CRP scores) are shown as positive numbers in these analyses. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (\>5.1=high disease activity; \<3.2=low disease activity; \<2.6=remission).
Time frame: Baseline, Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24 | Baseline | 5.71 Units on a scale | Standard Deviation 0.875 |
| Placebo | Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | NA Units on a scale | — |
| Placebo | Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -1.01 Units on a scale | Standard Deviation 1.245 |
| INCB028050 4 mg QD | Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24 | Baseline | 5.64 Units on a scale | Standard Deviation 1.098 |
| INCB028050 4 mg QD | Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -2.13 Units on a scale | Standard Deviation 1.355 |
| INCB028050 4 mg QD | Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -1.87 Units on a scale | Standard Deviation 1.231 |
| INCB028050 7 mg QD | Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -1.83 Units on a scale | Standard Deviation 1.534 |
| INCB028050 7 mg QD | Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24 | Baseline | 5.76 Units on a scale | Standard Deviation 0.925 |
| INCB028050 7 mg QD | Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -2.23 Units on a scale | Standard Deviation 1.548 |
| INCB028050 10 mg QD | Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24 | Baseline | 5.64 Units on a scale | Standard Deviation 0.774 |
| INCB028050 10 mg QD | Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -2.75 Units on a scale | Standard Deviation 1.234 |
| INCB028050 10 mg QD | Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -1.84 Units on a scale | Standard Deviation 1.143 |
Secondary
Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24
Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus Erythrocyte sedimentation rate (ESR). The DAS28-ESR is expressed as units on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR \<2.6. The mean change from baseline (which represent decreases in the DAS 28 ESR scores) are shown as positive numbers in these analyses.
Time frame: Baseline, Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24 | Baseline | 6.56 Units on a scale | Standard Deviation 0.84 |
| Placebo | Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | NA Units on a scale | — |
| Placebo | Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -1.25 Units on a scale | Standard Deviation 1.489 |
| INCB028050 4 mg QD | Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24 | Baseline | 6.41 Units on a scale | Standard Deviation 1.024 |
| INCB028050 4 mg QD | Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -2.17 Units on a scale | Standard Deviation 1.524 |
| INCB028050 4 mg QD | Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -1.87 Units on a scale | Standard Deviation 1.342 |
| INCB028050 7 mg QD | Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -1.97 Units on a scale | Standard Deviation 1.613 |
| INCB028050 7 mg QD | Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24 | Baseline | 6.35 Units on a scale | Standard Deviation 0.968 |
| INCB028050 7 mg QD | Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -2.29 Units on a scale | Standard Deviation 1.455 |
| INCB028050 10 mg QD | Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24 | Baseline | 6.37 Units on a scale | Standard Deviation 0.851 |
| INCB028050 10 mg QD | Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -2.79 Units on a scale | Standard Deviation 1.394 |
| INCB028050 10 mg QD | Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -1.90 Units on a scale | Standard Deviation 1.481 |
Secondary
Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Time frame: Baseline, Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24 | Baseline | 78.5 Minutes | Standard Deviation 61.36 |
| Placebo | Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | NA Minutes | — |
| Placebo | Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | 2.6 Minutes | Standard Deviation 69.23 |
| INCB028050 4 mg QD | Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24 | Baseline | 179.8 Minutes | Standard Deviation 347.48 |
| INCB028050 4 mg QD | Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -120.6 Minutes | Standard Deviation 245.35 |
| INCB028050 4 mg QD | Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -51.1 Minutes | Standard Deviation 94.8 |
| INCB028050 7 mg QD | Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -92.6 Minutes | Standard Deviation 250.51 |
| INCB028050 7 mg QD | Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24 | Baseline | 125.5 Minutes | Standard Deviation 246.75 |
| INCB028050 7 mg QD | Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -99.3 Minutes | Standard Deviation 254.05 |
| INCB028050 10 mg QD | Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24 | Baseline | 79.2 Minutes | Standard Deviation 56.83 |
| INCB028050 10 mg QD | Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -51.5 Minutes | Standard Deviation 70.84 |
| INCB028050 10 mg QD | Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -42.2 Minutes | Standard Deviation 63.97 |
Secondary
Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.
Time frame: Baseline, Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24 | Baseline | 40.8 mm/hr | Standard Deviation 15.4 |
| Placebo | Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | NA mm/hr | — |
| Placebo | Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -6.1 mm/hr | Standard Deviation 15.76 |
| INCB028050 4 mg QD | Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24 | Baseline | 42.8 mm/hr | Standard Deviation 17.62 |
| INCB028050 4 mg QD | Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -11.5 mm/hr | Standard Deviation 21.96 |
| INCB028050 4 mg QD | Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -7.5 mm/hr | Standard Deviation 23.17 |
| INCB028050 7 mg QD | Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -10.7 mm/hr | Standard Deviation 21.52 |
| INCB028050 7 mg QD | Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24 | Baseline | 37.3 mm/hr | Standard Deviation 21.56 |
| INCB028050 7 mg QD | Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -12.8 mm/hr | Standard Deviation 20.74 |
| INCB028050 10 mg QD | Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -11.1 mm/hr | Standard Deviation 26 |
| INCB028050 10 mg QD | Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -5.9 mm/hr | Standard Deviation 32.35 |
| INCB028050 10 mg QD | Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24 | Baseline | 34.8 mm/hr | Standard Deviation 29.05 |
Secondary
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Baseline, Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24 | Baseline | 1.61 Score on a scale | Standard Deviation 0.494 |
| Placebo | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 (n=31, 31, 30, 30) | -0.20 Score on a scale | Standard Deviation 0.367 |
| Placebo | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | NA Score on a scale | — |
| INCB028050 4 mg QD | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24 | Baseline | 1.50 Score on a scale | Standard Deviation 0.601 |
| INCB028050 4 mg QD | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -0.56 Score on a scale | Standard Deviation 0.673 |
| INCB028050 4 mg QD | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 (n=31, 31, 30, 30) | -0.38 Score on a scale | Standard Deviation 0.568 |
| INCB028050 7 mg QD | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 (n=31, 31, 30, 30) | -0.48 Score on a scale | Standard Deviation 0.613 |
| INCB028050 7 mg QD | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24 | Baseline | 1.67 Score on a scale | Standard Deviation 0.474 |
| INCB028050 7 mg QD | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -0.63 Score on a scale | Standard Deviation 0.563 |
| INCB028050 10 mg QD | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24 | Baseline | 1.50 Score on a scale | Standard Deviation 0.59 |
| INCB028050 10 mg QD | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -0.39 Score on a scale | Standard Deviation 0.469 |
| INCB028050 10 mg QD | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 (n=31, 31, 30, 30) | -0.33 Score on a scale | Standard Deviation 0.539 |
Secondary
Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24
Participants were to assess their current level of pain on a 100 mm horizontal Visual Analog Scale (VAS). The left-hand extreme of the line (0 mm) was described as no pain and the right-hand (100 mm) as most imaginable pain.
Time frame: Baseline, Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24 | Baseline | 62.37 millimeter (mm) | Standard Deviation 21.079 |
| Placebo | Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | NA millimeter (mm) | — |
| Placebo | Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -6.24 millimeter (mm) | Standard Deviation 22.065 |
| INCB028050 4 mg QD | Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24 | Baseline | 57.08 millimeter (mm) | Standard Deviation 24.716 |
| INCB028050 4 mg QD | Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -22.13 millimeter (mm) | Standard Deviation 27.294 |
| INCB028050 4 mg QD | Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -21.98 millimeter (mm) | Standard Deviation 26.275 |
| INCB028050 7 mg QD | Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -22.19 millimeter (mm) | Standard Deviation 25.631 |
| INCB028050 7 mg QD | Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24 | Baseline | 63.25 millimeter (mm) | Standard Deviation 18.656 |
| INCB028050 7 mg QD | Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -27.62 millimeter (mm) | Standard Deviation 25.015 |
| INCB028050 10 mg QD | Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24 | Baseline | 57.00 millimeter (mm) | Standard Deviation 22.995 |
| INCB028050 10 mg QD | Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -30.39 millimeter (mm) | Standard Deviation 30.847 |
| INCB028050 10 mg QD | Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -22.97 millimeter (mm) | Standard Deviation 37.691 |
Secondary
Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24
Participants were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no arthritis activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as extremely active arthritis (maximum arthritis disease activity). A decreasing mean score, therefore, indicates improvement.
Time frame: Baseline, Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24 | Baseline | 66.19 millimeter (mm) | Standard Deviation 20.522 |
| Placebo | Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | NA millimeter (mm) | — |
| Placebo | Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -8.61 millimeter (mm) | Standard Deviation 22.569 |
| INCB028050 4 mg QD | Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24 | Baseline | 59.02 millimeter (mm) | Standard Deviation 26.314 |
| INCB028050 4 mg QD | Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -22.06 millimeter (mm) | Standard Deviation 27.366 |
| INCB028050 4 mg QD | Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -24.02 millimeter (mm) | Standard Deviation 26.921 |
| INCB028050 7 mg QD | Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -31.53 millimeter (mm) | Standard Deviation 23.891 |
| INCB028050 7 mg QD | Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24 | Baseline | 69.69 millimeter (mm) | Standard Deviation 18.893 |
| INCB028050 7 mg QD | Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -27.41 millimeter (mm) | Standard Deviation 21.99 |
| INCB028050 10 mg QD | Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -34.08 millimeter (mm) | Standard Deviation 27.518 |
| INCB028050 10 mg QD | Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -25.48 millimeter (mm) | Standard Deviation 32.879 |
| INCB028050 10 mg QD | Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24 | Baseline | 62.25 millimeter (mm) | Standard Deviation 21.346 |
Secondary
Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24
Physicians were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no arthritis activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as extremely active arthritis (maximum arthritis disease activity). A decreasing mean score, therefore, indicates improvement.
Time frame: Baseline, Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | NA millimeter (mm) | — |
| Placebo | Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24 | Baseline | 63.45 millimeter (mm) | Standard Deviation 16.903 |
| Placebo | Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -20.23 millimeter (mm) | Standard Deviation 19.824 |
| INCB028050 4 mg QD | Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -38.78 millimeter (mm) | Standard Deviation 22.527 |
| INCB028050 4 mg QD | Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -33.87 millimeter (mm) | Standard Deviation 24.283 |
| INCB028050 4 mg QD | Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24 | Baseline | 61.94 millimeter (mm) | Standard Deviation 19.162 |
| INCB028050 7 mg QD | Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24 | Baseline | 59.80 millimeter (mm) | Standard Deviation 17.185 |
| INCB028050 7 mg QD | Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -29.95 millimeter (mm) | Standard Deviation 25.741 |
| INCB028050 7 mg QD | Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -36.94 millimeter (mm) | Standard Deviation 21.235 |
| INCB028050 10 mg QD | Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24 | Baseline | 59.32 millimeter (mm) | Standard Deviation 16.89 |
| INCB028050 10 mg QD | Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | -38.94 millimeter (mm) | Standard Deviation 21.776 |
| INCB028050 10 mg QD | Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | -30.88 millimeter (mm) | Standard Deviation 19.334 |
Secondary
Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best).
Time frame: Baseline, Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24 | Baseline | 71.08 scores on a scale | Standard Deviation 27.534 |
| Placebo | Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | NA scores on a scale | — |
| Placebo | Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | 2.92 scores on a scale | Standard Deviation 19.613 |
| INCB028050 4 mg QD | Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | 7.72 scores on a scale | Standard Deviation 17.543 |
| INCB028050 4 mg QD | Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | 7.87 scores on a scale | Standard Deviation 19.547 |
| INCB028050 4 mg QD | Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24 | Baseline | 69.03 scores on a scale | Standard Deviation 28.181 |
| INCB028050 7 mg QD | Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | 4.60 scores on a scale | Standard Deviation 17.146 |
| INCB028050 7 mg QD | Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | 2.21 scores on a scale | Standard Deviation 17.814 |
| INCB028050 7 mg QD | Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24 | Baseline | 78.41 scores on a scale | Standard Deviation 30.329 |
| INCB028050 10 mg QD | Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24 | Baseline | 78.62 scores on a scale | Standard Deviation 24.16 |
| INCB028050 10 mg QD | Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | 6.36 scores on a scale | Standard Deviation 25.203 |
| INCB028050 10 mg QD | Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | 2.29 scores on a scale | Standard Deviation 28.869 |
Secondary
Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best).
Time frame: Baseline, Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24 | Baseline | 29.14 scores on a scale | Standard Deviation 14.33 |
| Placebo | Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | NA scores on a scale | — |
| Placebo | Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | 3.72 scores on a scale | Standard Deviation 11.027 |
| INCB028050 4 mg QD | Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24 | Baseline | 34.67 scores on a scale | Standard Deviation 16.006 |
| INCB028050 4 mg QD | Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | 9.57 scores on a scale | Standard Deviation 14.96 |
| INCB028050 4 mg QD | Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | 11.60 scores on a scale | Standard Deviation 14.503 |
| INCB028050 7 mg QD | Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | 12.97 scores on a scale | Standard Deviation 17.932 |
| INCB028050 7 mg QD | Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | 15.56 scores on a scale | Standard Deviation 16.144 |
| INCB028050 7 mg QD | Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24 | Baseline | 26.71 scores on a scale | Standard Deviation 14.642 |
| INCB028050 10 mg QD | Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24 | Baseline | 28.82 scores on a scale | Standard Deviation 14.212 |
| INCB028050 10 mg QD | Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24 | Change from baseline at Week 24 | 11.77 scores on a scale | Standard Deviation 13.387 |
| INCB028050 10 mg QD | Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24 | Change from baseline at Week 12 | 8.35 scores on a scale | Standard Deviation 13.947 |
Secondary
Participants With at Least 1 Adverse Event From Week 12 to Week 24
Time frame: Week 12 to Week 24
Population: Safety Evaluable Participants included all participants who were enrolled and took at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Participants With at Least 1 Adverse Event From Week 12 to Week 24 | 6 Participants |
| INCB028050 4 mg QD | Participants With at Least 1 Adverse Event From Week 12 to Week 24 | 5 Participants |
| INCB028050 7 mg QD | Participants With at Least 1 Adverse Event From Week 12 to Week 24 | 12 Participants |
| INCB028050 10 mg QD | Participants With at Least 1 Adverse Event From Week 12 to Week 24 | 16 Participants |
| INCB028050 10 mg QD | Participants With at Least 1 Adverse Event From Week 12 to Week 24 | 16 Participants |
Secondary
Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 12
EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 2.6.
Time frame: Week 12
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 12 | 26.0 percentage of participants |
| INCB028050 4 mg QD | Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 12 | 39.0 percentage of participants |
| INCB028050 7 mg QD | Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 12 | 34.0 percentage of participants |
| INCB028050 10 mg QD | Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 12 | 33.0 percentage of participants |
Secondary
Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 24
EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 2.6.
Time frame: Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 24 | 48.0 percentage of participants |
| INCB028050 4 mg QD | Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 24 | 53.0 percentage of participants |
| INCB028050 7 mg QD | Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 24 | 65.0 percentage of participants |
Secondary
Percentage of Participants Achieving Good EULAR Response (DAS28ESR) at Week 24
EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.
Time frame: Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Good EULAR Response (DAS28ESR) at Week 24 | 21.0 percentage of participants |
| INCB028050 4 mg QD | Percentage of Participants Achieving Good EULAR Response (DAS28ESR) at Week 24 | 15.0 percentage of participants |
| INCB028050 7 mg QD | Percentage of Participants Achieving Good EULAR Response (DAS28ESR) at Week 24 | 33.0 percentage of participants |
| INCB028050 10 mg QD | Percentage of Participants Achieving Good EULAR Response (DAS28ESR) at Week 24 | 43.0 percentage of participants |
| INCB028050 10 mg QD | Percentage of Participants Achieving Good EULAR Response (DAS28ESR) at Week 24 | 39.0 percentage of participants |
Secondary
Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response (DAS28 ESR) at Week 12
EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.
Time frame: Week 12
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response (DAS28 ESR) at Week 12 | 19.0 percentage of participants |
| INCB028050 4 mg QD | Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response (DAS28 ESR) at Week 12 | 23.0 percentage of participants |
| INCB028050 7 mg QD | Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response (DAS28 ESR) at Week 12 | 31.0 percentage of participants |
| INCB028050 10 mg QD | Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response (DAS28 ESR) at Week 12 | 13.0 percentage of participants |
Secondary
Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2
Participants who achieved low disease activity based on the DAS 28 ESR (score ≤3.2). Participants who achieved low disease activity were classified as responders in this analysis.
Time frame: Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2 | Week 12 | 19.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2 | Week 24 | NA percentage of participants |
| INCB028050 4 mg QD | Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2 | Week 24 | 48.0 percentage of participants |
| INCB028050 4 mg QD | Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2 | Week 12 | 23.0 percentage of participants |
| INCB028050 7 mg QD | Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2 | Week 12 | 31.0 percentage of participants |
| INCB028050 7 mg QD | Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2 | Week 24 | 53.0 percentage of participants |
| INCB028050 10 mg QD | Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2 | Week 12 | 13.0 percentage of participants |
| INCB028050 10 mg QD | Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2 | Week 24 | 65.0 percentage of participants |
Secondary
Percentage of Participants Achieving Remission by DAS28 (CRP) ≤2.6
Participants who achieved inactive disease based on DAS 28 CRP (score ≤2.6). Participants who achieved low disease activity were classified as responders in this analysis.
Time frame: Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Remission by DAS28 (CRP) ≤2.6 | Week 12 | 23.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Remission by DAS28 (CRP) ≤2.6 | Week 24 | 30.0 percentage of participants |
| INCB028050 4 mg QD | Percentage of Participants Achieving Remission by DAS28 (CRP) ≤2.6 | Week 12 | 25.0 percentage of participants |
| INCB028050 4 mg QD | Percentage of Participants Achieving Remission by DAS28 (CRP) ≤2.6 | Week 24 | 40.0 percentage of participants |
| INCB028050 7 mg QD | Percentage of Participants Achieving Remission by DAS28 (CRP) ≤2.6 | Week 12 | 17.0 percentage of participants |
| INCB028050 7 mg QD | Percentage of Participants Achieving Remission by DAS28 (CRP) ≤2.6 | Week 24 | 48.0 percentage of participants |
Secondary
Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6
Participants who achieved inactive disease based on the DAS 28 ESR (score ≤2.6). Participants who achieved low disease activity were classified as responders in this analysis.
Time frame: Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6 | Week 12 | 6.7 percentage of participants |
| Placebo | Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6 | Week 24 | 21.4 percentage of participants |
| INCB028050 4 mg QD | Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6 | Week 12 | 18.8 percentage of participants |
| INCB028050 4 mg QD | Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6 | Week 24 | 23.1 percentage of participants |
| INCB028050 7 mg QD | Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6 | Week 12 | 16.0 percentage of participants |
| INCB028050 7 mg QD | Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6 | Week 24 | 22.0 percentage of participants |
| INCB028050 10 mg QD | Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6 | Week 24 | 27.0 percentage of participants |
| INCB028050 10 mg QD | Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6 | Week 12 | 19.0 percentage of participants |
| INCB028050 10 mg QD | Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6 | Week 12 | 7.0 percentage of participants |
| INCB028050 10 mg QD | Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6 | Week 24 | 26.0 percentage of participants |
Secondary
Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24
Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no pain and the right-hand (100 mm) as most imaginable pain. MCID for the pain score is a decrease of at least 10 mm on a 100 mm scale.
Time frame: Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24 | Week 12 | 35.0 percentage of participants |
| Placebo | Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24 | Week 24 | NA percentage of participants |
| INCB028050 4 mg QD | Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24 | Week 24 | 59.0 percentage of participants |
| INCB028050 4 mg QD | Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24 | Week 12 | 58.0 percentage of participants |
| INCB028050 7 mg QD | Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24 | Week 12 | 69.0 percentage of participants |
| INCB028050 7 mg QD | Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24 | Week 24 | 70.0 percentage of participants |
| INCB028050 10 mg QD | Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24 | Week 12 | 67.0 percentage of participants |
| INCB028050 10 mg QD | Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24 | Week 24 | 72.0 percentage of participants |
Secondary
Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best).
Time frame: Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 | Week 12 Physical Components | 52.0 percentage of participants |
| Placebo | Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 | Week 24 Mental Components | NA percentage of participants |
| Placebo | Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 | Week 24 Physical Components | NA percentage of participants |
| Placebo | Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 | Week 12 Mental Components | 52.0 percentage of participants |
| INCB028050 4 mg QD | Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 | Week 12 Mental Components | 58.0 percentage of participants |
| INCB028050 4 mg QD | Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 | Week 24 Mental Components | 63.0 percentage of participants |
| INCB028050 4 mg QD | Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 | Week 24 Physical Components | 67.0 percentage of participants |
| INCB028050 4 mg QD | Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 | Week 12 Physical Components | 68.0 percentage of participants |
| INCB028050 7 mg QD | Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 | Week 12 Physical Components | 69.0 percentage of participants |
| INCB028050 7 mg QD | Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 | Week 24 Physical Components | 77.0 percentage of participants |
| INCB028050 7 mg QD | Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 | Week 12 Mental Components | 41.0 percentage of participants |
| INCB028050 7 mg QD | Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 | Week 24 Mental Components | 57.0 percentage of participants |
| INCB028050 10 mg QD | Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 | Week 24 Physical Components | 76.0 percentage of participants |
| INCB028050 10 mg QD | Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 | Week 24 Mental Components | 52.0 percentage of participants |
| INCB028050 10 mg QD | Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 | Week 12 Physical Components | 57.0 percentage of participants |
| INCB028050 10 mg QD | Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 | Week 12 Mental Components | 50.0 percentage of participants |
Secondary
Percent of Participants Achieving a Minimum Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 and Week 24
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. The MCID score for HAQ-DI is -0.22.
Time frame: Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percent of Participants Achieving a Minimum Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 and Week 24 | Week 12 (n=31, 31, 30, 30) | 45.0 percentage of participants |
| Placebo | Percent of Participants Achieving a Minimum Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 and Week 24 | Week 24 | NA percentage of participants |
| INCB028050 4 mg QD | Percent of Participants Achieving a Minimum Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 and Week 24 | Week 24 | 67.0 percentage of participants |
| INCB028050 4 mg QD | Percent of Participants Achieving a Minimum Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 and Week 24 | Week 12 (n=31, 31, 30, 30) | 61.0 percentage of participants |
| INCB028050 7 mg QD | Percent of Participants Achieving a Minimum Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 and Week 24 | Week 12 (n=31, 31, 30, 30) | 63.0 percentage of participants |
| INCB028050 7 mg QD | Percent of Participants Achieving a Minimum Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 and Week 24 | Week 24 | 75.0 percentage of participants |
| INCB028050 10 mg QD | Percent of Participants Achieving a Minimum Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 and Week 24 | Week 24 | 60.0 percentage of participants |
| INCB028050 10 mg QD | Percent of Participants Achieving a Minimum Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 and Week 24 | Week 12 (n=31, 31, 30, 30) | 43.0 percentage of participants |
Secondary
The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24
The ACR 50 is defined as ≥ 50% improvement in tender joint count plus ≥ 50% improvement in swollen joint count plus ≥50% improvement in 3 of the following 5 criteria: participants' assessment of pain, PGA, PHGA, participants' self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.
Time frame: Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24 | Week 12 | 13.0 percentage of participants |
| Placebo | The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24 | Week 24 | NA percentage of participants |
| INCB028050 4 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24 | Week 24 | 33.0 percentage of participants |
| INCB028050 4 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24 | Week 12 | 35.0 percentage of participants |
| INCB028050 7 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24 | Week 12 | 31.0 percentage of participants |
| INCB028050 7 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24 | Week 24 | 37.0 percentage of participants |
| INCB028050 10 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24 | Week 12 | 30.0 percentage of participants |
| INCB028050 10 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24 | Week 24 | 44.0 percentage of participants |
Secondary
The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24
The ACR 70 is defined as ≥ 70% improvement in tender joint count plus ≥ 70% improvement in swollen joint count plus ≥ 70% improvement in 3 of the following 5 criteria: participants' assessment of pain, PGA, PHGA, participants' self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.
Time frame: Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24 | Week 12 | 3.0 percentage of participants |
| Placebo | The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24 | Week 24 | NA percentage of participants |
| INCB028050 4 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24 | Week 24 | 26.0 percentage of participants |
| INCB028050 4 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24 | Week 12 | 16.0 percentage of participants |
| INCB028050 7 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24 | Week 12 | 9.0 percentage of participants |
| INCB028050 7 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24 | Week 24 | 30.0 percentage of participants |
| INCB028050 10 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24 | Week 12 | 10.0 percentage of participants |
| INCB028050 10 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24 | Week 24 | 28.0 percentage of participants |
Secondary
The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24
The ACR 90 is defined greater than or equal to (\>=) 90 percent (%) improvement in painful and tender joint count; \>= 90% improvement in swollen joint count; and \>= 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP) at each visit.
Time frame: Week 12 and Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants that enrolled, took at least 1 dose of study medication, and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24 | Week 12 | 0.0 percentage of participants |
| Placebo | The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24 | Week 24 | NA percentage of participants |
| INCB028050 4 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24 | Week 24 | 11.0 percentage of participants |
| INCB028050 4 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24 | Week 12 | 3.0 percentage of participants |
| INCB028050 7 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24 | Week 12 | 0.0 percentage of participants |
| INCB028050 7 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24 | Week 24 | 10.0 percentage of participants |
| INCB028050 10 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24 | Week 12 | 3.0 percentage of participants |
| INCB028050 10 mg QD | The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24 | Week 24 | 12.0 percentage of participants |
Secondary
The Percentage of Participants Who Were Assigned to Active Treatment at Baseline Achieving ACR 20 Improvement at Week 24
The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: participants' assessment of pain, participants' global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), participants' self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.
Time frame: From Baseline to Week 24
Population: Modified Intent-to-Treat (mITT) population included all participants who were assigned to active treatment at baseline and had both pre-dose and at least 1 post-baseline Rheumatoid arthritis (RA) assessment before Week 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | The Percentage of Participants Who Were Assigned to Active Treatment at Baseline Achieving ACR 20 Improvement at Week 24 | 18 Participants |
| INCB028050 4 mg QD | The Percentage of Participants Who Were Assigned to Active Treatment at Baseline Achieving ACR 20 Improvement at Week 24 | 20 Participants |
| INCB028050 7 mg QD | The Percentage of Participants Who Were Assigned to Active Treatment at Baseline Achieving ACR 20 Improvement at Week 24 | 18 Participants |