Back to resultsINCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
INCB028050
INCB028050
INCB028050
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
INCB028050 4 mg QD
INCB028050 7 mg QD
INCB028050 10 mg QD
Placebo
Arm Description
INCB028050 4mg Once daily (QD)
INCB028050 7mg QD
INCB028050 10mg QD
Placebo group may 'cross-over' following 3 months of treatment to receive either active arm #2 (7mg QD) or active arm #3 (10mg QD) of INCB028050 capsules.
Outcomes
Primary Outcome Measures
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.
Participants With at Least 1 Adverse Event From Baseline Through Week 12
Secondary Outcome Measures
Participants With at Least 1 Adverse Event From Week 12 to Week 24
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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".
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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").
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").
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.
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.
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").
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00902486
Brief Title
INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs
Official Title
A Randomized, Double-blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients With Active RA With Inadequate Response to Any Disease Modifying Anti-Rheumatic Drugs (DMARD) Therapy Including Biologics
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INCB028050 4 mg QD
Arm Type
Experimental
Arm Description
INCB028050 4mg Once daily (QD)
Arm Title
INCB028050 7 mg QD
Arm Type
Experimental
Arm Description
INCB028050 7mg QD
Arm Title
INCB028050 10 mg QD
Arm Type
Experimental
Arm Description
INCB028050 10mg QD
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group may 'cross-over' following 3 months of treatment to receive either active arm #2 (7mg QD) or active arm #3 (10mg QD) of INCB028050 capsules.
Intervention Type
Drug
Intervention Name(s)
INCB028050
Other Intervention Name(s)
Baricitinib
Intervention Description
4 mg capsules QD
Intervention Type
Drug
Intervention Name(s)
INCB028050
Other Intervention Name(s)
Baricitinib
Intervention Description
7 mg capsules QD
Intervention Type
Drug
Intervention Name(s)
INCB028050
Other Intervention Name(s)
Baricitinib
Intervention Description
10 mg capsule QD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching INCB028050 QD
Primary Outcome Measure Information:
Title
The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement
Description
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
Title
Participants With at Least 1 Adverse Event From Baseline Through Week 12
Time Frame
From Baseline through week 12
Secondary Outcome Measure Information:
Title
Participants With at Least 1 Adverse Event From Week 12 to Week 24
Time Frame
Week 12 to Week 24
Title
The Percentage of Participants Who Were Assigned to Active Treatment at Baseline Achieving ACR 20 Improvement at Week 24
Description
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
Title
The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24
Description
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
Title
The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24
Description
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
Title
The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24
Description
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
Title
Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24
Description
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
Title
Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24
Description
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
Title
Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2
Description
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
Title
Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6
Description
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
Title
Percentage of Participants Achieving Remission by DAS28 (CRP) ≤2.6
Description
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
Title
Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24
Description
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
Title
Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24
Description
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
Title
Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24
Description
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
Title
Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24
Description
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
Title
Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24
Description
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
Title
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24
Description
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
Title
Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24
Description
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
Title
Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24
Description
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
Title
Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24
Description
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
Title
Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response (DAS28 ESR) at Week 12
Description
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
Title
Percentage of Participants Achieving Good EULAR Response (DAS28ESR) at Week 24
Description
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
Title
Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 12
Description
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
Title
Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 24
Description
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
Title
Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24
Description
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
Title
Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24
Description
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
Title
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
Description
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
Title
Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24
Description
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
Title
Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Paradise Valley
State/Province
Arizona
Country
United States
City
Peoria
State/Province
Arizona
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Palm Desert
State/Province
California
Country
United States
City
Santa Maria
State/Province
California
Country
United States
City
Santa Monica
State/Province
California
Country
United States
City
Westlake Village
State/Province
California
Country
United States
City
Whittier
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Aventura
State/Province
Florida
Country
United States
City
Daytona Beach
State/Province
Florida
Country
United States
City
Gainesville
State/Province
Florida
Country
United States
City
Lake Mary
State/Province
Florida
Country
United States
City
Naples
State/Province
Florida
Country
United States
City
Palm Harbor
State/Province
Florida
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
City
Springfield
State/Province
Illinois
Country
United States
City
South Bend
State/Province
Indiana
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Frederick
State/Province
Maryland
Country
United States
City
Wheaton
State/Province
Maryland
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Lincoln
State/Province
Nebraska
Country
United States
City
Reno
State/Province
Nevada
Country
United States
City
Freehold
State/Province
New Jersey
Country
United States
City
Lake Success
State/Province
New York
Country
United States
City
Syracuse
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Hickory
State/Province
North Carolina
Country
United States
City
Middleburg Heights
State/Province
Ohio
Country
United States
City
Toledo
State/Province
Ohio
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Sellersville
State/Province
Pennsylvania
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Arlington
State/Province
Virginia
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
Brno
Country
Czechia
City
Ceska Lipa
Country
Czechia
City
Chomutov
Country
Czechia
City
Hlucin
Country
Czechia
City
Hustopece
Country
Czechia
City
Kromeriz
Country
Czechia
City
Praha
Country
Czechia
City
Zlin
Country
Czechia
12. IPD Sharing Statement
Citations:
PubMed Identifier
34706874
Citation
Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.
Results Reference
derived
PubMed Identifier
30842122
Citation
Combe B, Balsa A, Sarzi-Puttini P, Tony HP, de la Torre I, Rogai V, Durand F, Witt S, Zhong J, Dougados M. Efficacy and safety data based on historical or pre-existing conditions at baseline for patients with active rheumatoid arthritis who were treated with baricitinib. Ann Rheum Dis. 2019 Aug;78(8):1135-1138. doi: 10.1136/annrheumdis-2018-214261. Epub 2019 Mar 6. No abstract available.
Results Reference
derived
PubMed Identifier
29463520
Citation
Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20.
Results Reference
derived
Learn more about this trial
INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs
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