We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis (RA-BEYOND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01885078
Recruitment Status : Completed
First Posted : June 24, 2013
Results First Posted : February 1, 2022
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Baricitinib
Drug: Placebo
Enrollment 2877
Recruitment Details Participants were eligible to participate in the Step-down period if they achieved a sustained (at least 3 months in JADY) low disease activity (CDAI score ≤10; for participants originating in Studies JADV, JADX, JADW, and JAGS) or sustained remission (CDAI score ≤2.8; for participants originating in Study JADZ). Eligible participants were randomized to 4 mg or 2 mg baricitinib once daily to evaluate if treatment with 2 mg maintains the low disease activity achieved with 4 mg baricitinib.
Pre-assignment Details

Participants who completed an originating study:

I4V-MC-JADZ (NCT01711359), I4V-MC-JADV (NCT017103580, I4V-MC-JADX (NCT01721057), I4V-MC-JADW (NCT01721044), I4V-MC-JADA (NCT01185353), or I4V-MC-JAGS (NCT02265705) were eligible for enrollment into study JADY.

Arm/Group Title JADZ 4 Milligram (mg) Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib 2 mg Baricitinib Step-down 4 mg Baricitinib Step-down
Hide Arm/Group Description 4 mg Baricitinib administered orally once daily. 4 mg Baricitinib administered orally once daily. 2 mg Baricitinib administered orally once daily. 4 mg Baricitinib administered orally once daily. 2 mg Baricitinib administered orally once daily. 4 mg Baricitinib administered orally once daily. 4 mg Baricitinib administered orally once daily. 4 mg Baricitinib administered orally once daily. 2 mg Baricitinib administered orally once daily in the 96-week Step-down period. 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.
Period Title: Treatment Period
Started 451 1091 180 403 117 331 221 83 0 0
Received at Least Once Dose of Study Drug 451 1090 180 403 117 331 221 83 0 0
Completed 19 64 49 120 27 81 0 55 0 0
Not Completed 432 1027 131 283 90 250 221 28 0 0
Reason Not Completed
Adverse Event             52             136             30             73             17             72             24             5             0             0
Death             13             33             5             9             2             10             3             2             0             0
Lack of Efficacy             12             33             10             23             24             58             9             5             0             0
Lost to Follow-up             16             19             7             9             2             8             2             0             0             0
Physician Decision             19             21             5             12             9             24             4             3             0             0
Protocol Violation             3             5             0             3             1             6             0             0             0             0
Sponsor Decision             245             648             49             90             20             38             162             3             0             0
Withdrawal by Subject             72             132             25             63             15             34             17             10             0             0
Other             0             0             0             1             0             0             0             0             0             0
Period Title: Step-down Period
Started 0 [1] 0 [1] 0 [1] 0 [1] 0 [1] 0 [1] 0 0 [1] 592 [2] 594 [2]
Complete Through Week 96 0 0 0 0 0 0 0 0 407 455
Completed 0 0 0 0 0 0 0 0 523 533
Not Completed 0 0 0 0 0 0 0 0 69 61
Reason Not Completed
Sponsor Decision             0             0             0             0             0             0             0             0             1             1
Adverse Event             0             0             0             0             0             0             0             0             29             38
Withdrawal by Subject             0             0             0             0             0             0             0             0             25             15
Physician Decision             0             0             0             0             0             0             0             0             7             2
Death             0             0             0             0             0             0             0             0             4             3
Lost to Follow-up             0             0             0             0             0             0             0             0             1             1
Lack of Efficacy             0             0             0             0             0             0             0             0             1             0
Protocol Violation             0             0             0             0             0             0             0             0             1             1
[1]
Not all participants were eligible to enter the Step-Down Period.
[2]
Eligible participants were offered the option of participating in the Step-Down Period.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib Total
Hide Arm/Group Description 4 mg Baricitinib administered orally once daily. 4 mg Baricitinib administered orally once daily. 2 mg Baricitinib administered orally once daily. 4 mg Baricitinib administered orally once daily. 2 mg Baricitinib administered orally once daily. 4 mg Baricitinib administered orally once daily. 4 mg Baricitinib administered orally once daily. 4 mg Baricitinib administered orally once daily. Total of all reporting groups
Overall Number of Baseline Participants 451 1090 180 403 117 331 221 83 2876
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 451 participants 1090 participants 180 participants 403 participants 117 participants 331 participants 221 participants 83 participants 2876 participants
<=18 years 0 0 0 0 0 0 0 0 0
Between 18 and 65 years 386 881 150 335 86 253 199 68 2358
>=65 years 65 209 30 68 31 78 22 15 518
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 451 participants 1090 participants 180 participants 403 participants 117 participants 331 participants 221 participants 83 participants 2876 participants
Female 326 847 144 335 87 275 177 71 2262
Male 125 243 36 68 30 56 44 12 614
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 451 participants 1090 participants 180 participants 403 participants 117 participants 331 participants 221 participants 83 participants 2876 participants
American Indian or Alaska Native 35 56 1 12 6 21 6 6 143
Asian 122 321 50 94 6 19 167 2 781
Native Hawaiian or Other Pacific Islander 0 0 0 1 0 0 0 0 1
Black or African American 17 4 9 10 7 12 3 2 64
White 275 691 119 283 98 275 45 73 1859
More than one race 2 17 1 2 0 1 0 0 23
Unknown or Not Reported 0 1 0 1 0 3 0 0 5
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 451 participants 1090 participants 180 participants 403 participants 117 participants 331 participants 221 participants 83 participants 2876 participants
United States 68 64 39 103 52 136 0 26 488
Czechia 0 29 3 10 0 0 0 14 56
Portugal 3 3 2 3 0 0 0 0 11
Russia 35 70 10 7 0 0 0 0 122
Greece 0 2 0 0 2 4 0 0 8
South Korea 6 43 6 8 3 6 0 0 72
Latvia 0 8 0 0 0 0 0 0 8
Sweden 3 0 0 0 0 0 0 0 3
Austria 2 0 0 0 3 12 0 0 17
Netherlands 0 0 0 0 1 0 0 0 1
China 0 41 0 0 0 0 167 0 208
Poland 0 66 11 37 9 22 0 11 156
Brazil 16 0 0 0 0 0 14 0 30
Slovenia 0 5 0 0 0 0 0 0 5
Slovakia 0 17 3 7 0 0 0 0 27
France 0 16 0 0 6 14 0 0 36
Lithuania 0 21 0 0 0 0 0 0 21
Croatia 0 0 2 1 0 0 0 6 9
Argentina 87 226 15 44 3 15 40 0 430
Romania 0 14 2 2 0 0 0 3 21
Hungary 0 30 8 11 0 0 0 11 60
Japan 82 215 4 13 3 11 0 0 328
United Kingdom 10 8 3 1 1 3 0 0 26
Switzerland 0 0 0 0 0 7 0 0 7
India 28 0 16 27 0 0 0 0 71
Spain 0 28 9 24 6 19 0 0 86
Canada 13 8 8 13 3 2 0 0 47
Turkey 0 0 0 0 1 2 0 0 3
Belgium 20 7 3 8 0 3 0 0 41
Taiwan 0 12 23 46 0 0 0 0 81
Denmark 0 0 0 0 2 3 0 0 5
South Africa 16 40 0 0 0 0 0 0 56
Italy 12 0 3 6 3 3 0 0 27
Mexico 39 115 8 14 5 21 0 12 214
Israel 0 0 0 0 6 21 0 0 27
Australia 0 0 1 12 5 14 0 0 32
Germany 11 2 1 6 3 13 0 0 36
1.Primary Outcome
Title Number of Participants Who Experienced Adverse Events (AEs) or Serious AE
Hide Description

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (i.e., abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Non-serious AEs are reported at a threshold of 5%.

An SAE is an AE from this study that results in any of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, considered significant by the investigator for any other reason

A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.

Time Frame Baseline through 84 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and did not discontinue the study for the reason 'Lost to Follow-up' at the first postbaseline visit in study JADY.
Arm/Group Title 2 mg Baricitinib 4 mg Baricitinib 2 mg Baricitinib Step-down 4 mg Baricitinib Step-down
Hide Arm/Group Description:
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily in the 96-week Step-down period.
4 mg Baricitinib administered orally once daily in the 96-week Step-down period.
Overall Number of Participants Analyzed 297 2579 592 594
Measure Type: Number
Unit of Measure: participants
Adverse Events 234 1532 270 315
Serious Adverse Events 112 517 164 178
2.Secondary Outcome
Title Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
Hide Description ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100
Time Frame Year 1 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
92.6
(89.7 to 94.7)
88.4
(86.3 to 90.2)
79.3
(72.6 to 84.7)
79.5
(75.1 to 83.3)
72.3
(62.9 to 80.1)
70.8
(65.2 to 75.9)
86.7
(81.4 to 90.6)
75.6
(65.1 to 83.8)
3.Secondary Outcome
Title Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
Hide Description ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100
Time Frame Year 3 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
78.3
(74.1 to 82.0)
76.6
(73.9 to 79.1)
71.6
(64.4 to 77.9)
70.5
(65.6 to 74.9)
57.4
(47.7 to 66.6)
55.8
(49.9 to 61.6)
73.8
(67.5 to 79.3)
71.8
(61.0 to 80.6)
4.Secondary Outcome
Title Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
Hide Description ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100
Time Frame Year 5 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67.3
(62.7 to 71.6)
65.6
(62.6 to 68.4)
60.4
(52.8 to 67.4)
56.0
(50.9 to 61.0)
50.5
(40.9 to 60.0)
43.1
(37.3 to 49.0)
24.8
(19.4 to 31.0)
60.3
(49.2 to 70.4)
5.Secondary Outcome
Title Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
Hide Description ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100
Time Frame Year 1 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
80.0
(75.9 to 83.5)
67.7
(64.8 to 70.5)
58.0
(50.5 to 65.2)
58.2
(53.1 to 63.1)
45.5
(36.2 to 55.2)
43.8
(38.0 to 49.7)
69.0
(62.5 to 74.9)
43.6
(33.1 to 54.6)
6.Secondary Outcome
Title Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
Hide Description ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100
Time Frame Year 3 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67.8
(63.2 to 72.1)
61.6
(58.6 to 64.5)
49.7
(42.3 to 57.2)
53.3
(48.2 to 58.3)
43.6
(34.3 to 53.3)
36.5
(31.0 to 42.3)
59.0
(52.3 to 65.5)
43.6
(33.1 to 54.6)
7.Secondary Outcome
Title Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
Hide Description ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100
Time Frame Year 5 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
59.9
(55.1 to 64.5)
52.7
(49.7 to 55.7)
44.4
(37.1 to 51.9)
43.2
(38.2 to 48.3)
37.6
(28.8 to 47.4)
32.1
(26.9 to 37.9)
18.6
(13.9 to 24.4)
37.2
(27.3 to 48.3)
8.Secondary Outcome
Title Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
Hide Description ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100
Time Frame Year 1 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61.3
(56.6 to 65.9)
45.7
(42.7 to 48.8)
34.9
(28.1 to 42.4)
35.8
(31.1 to 40.8)
28.7
(20.8 to 38.2)
25.9
(21.1 to 31.4)
42.9
(36.4 to 49.6)
26.9
(18.3 to 37.7)
9.Secondary Outcome
Title Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
Hide Description ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100
Time Frame Year 3 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.4
(49.6 to 59.1)
44.1
(41.1 to 47.1)
35.5
(28.7 to 43.0)
32.5
(27.9 to 37.5)
24.8
(17.4 to 34.0)
21.5
(17.1 to 26.8)
35.2
(29.1 to 41.9)
21.8
(14.1 to 32.2)
10.Secondary Outcome
Title Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
Hide Description ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100
Time Frame Year 5 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 Milligram (mg) Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
48.2
(43.5 to 53.0)
39.1
(36.1 to 42.1)
28.4
(22.1 to 35.6)
28.4
(24.0 to 33.2)
23.8
(16.5 to 32.9)
18.2
(14.1 to 23.2)
12.9
(9.0 to 18.1)
19.2
(12.0 to 29.3)
11.Secondary Outcome
Title Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2
Hide Description Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame Year 1 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.9
(77.9 to 85.3)
71.9
(69.0 to 74.5)
66.3
(58.9 to 73.0)
68.6
(63.7 to 73.1)
50.5
(40.9 to 60.0)
51.1
(45.2 to 57.0)
72.4
(66.0 to 78.0)
59.0
(47.9 to 69.2)
12.Secondary Outcome
Title Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2
Hide Description Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame Year 3 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
71.8
(67.3 to 75.9)
65.5
(62.5 to 68.3)
59.2
(51.6 to 66.3)
59.3
(54.2 to 64.2)
47.5
(38.1 to 57.2)
41.6
(35.9 to 47.5)
61.0
(54.2 to 67.3)
60.3
(49.2 to 70.4)
13.Secondary Outcome
Title Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2
Hide Description Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame Year 5 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61.1
(56.3 to 65.6)
58.9
(55.9 to 61.9)
46.7
(39.4 to 54.3)
50.0
(44.9 to 55.1)
44.6
(35.2 to 54.3)
34.3
(28.9 to 40.1)
21.0
(16.0 to 27.0)
53.8
(42.9 to 64.5)
14.Secondary Outcome
Title Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Hide Description Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame Year 1 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 Milligram (mg) Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
65.6
(61.0 to 70.0)
52.3
(49.3 to 55.4)
50.9
(43.4 to 58.3)
46.2
(41.1 to 51.3)
34.7
(26.1 to 44.3)
32.8
(27.6 to 38.6)
52.4
(45.6 to 59.0)
44.9
(34.3 to 55.9)
15.Secondary Outcome
Title Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Hide Description Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame Year 3 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
59.9
(55.1 to 64.5)
51.0
(47.9 to 54.0)
43.8
(36.5 to 51.3)
43.2
(38.2 to 48.3)
31.7
(23.4 to 41.3)
26.3
(21.4 to 31.8)
38.6
(32.2 to 45.3)
35.9
(26.1 to 47.0)
16.Secondary Outcome
Title Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Hide Description Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame Year 5 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
51.1
(46.3 to 55.8)
44.0
(41.0 to 47.0)
36.1
(29.2 to 43.6)
37.7
(32.9 to 42.8)
29.7
(21.7 to 39.2)
26.6
(21.8 to 32.2)
13.3
(9.4 to 18.6)
43.6
(33.1 to 54.6)
17.Secondary Outcome
Title Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2
Hide Description DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame Year 1 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61.8
(57.1 to 66.3)
48.4
(45.3 to 51.4)
46.2
(38.8 to 53.7)
48.4
(43.3 to 53.5)
31.7
(23.4 to 41.3)
31.8
(26.5 to 37.5)
41.0
(34.5 to 47.7)
35.9
(26.1 to 47.0)
18.Secondary Outcome
Title Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2
Hide Description DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame Year 3 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.4
(49.6 to 59.1)
46.1
(43.1 to 49.2)
40.2
(33.1 to 47.8)
41.0
(36.1 to 46.1)
22.8
(15.7 to 31.9)
23.7
(19.1 to 29.1)
33.8
(27.8 to 40.4)
37.2
(27.3 to 48.3)
19.Secondary Outcome
Title Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2
Hide Description DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame Year 5 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
48.7
(43.9 to 53.5)
41.3
(38.3 to 44.3)
36.1
(29.2 to 43.6)
32.5
(27.9 to 37.5)
23.8
(16.5 to 32.9)
21.9
(17.4 to 27.2)
11.4
(7.8 to 16.4)
37.2
(27.3 to 48.3)
20.Secondary Outcome
Title Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
Hide Description DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame Year 1 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36.8
(32.3 to 41.5)
29.3
(26.6 to 32.2)
24.3
(18.4 to 31.2)
26.8
(22.5 to 31.5)
20.8
(14.0 to 29.7)
13.1
(9.6 to 17.7)
25.2
(19.8 to 31.5)
15.4
(9.0 to 25.0)
21.Secondary Outcome
Title Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
Hide Description DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame Year 3 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.9
(34.4 to 43.7)
24.7
(22.1 to 27.4)
24.3
(18.4 to 31.2)
23.2
(19.2 to 27.8)
15.8
(10.0 to 24.2)
10.2
(7.2 to 14.4)
19.5
(14.7 to 25.4)
23.1
(15.1 to 33.6)
22.Secondary Outcome
Title Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
Hide Description DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame Year 5 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31.3
(27.0 to 35.9)
23.9
(21.4 to 26.6)
22.5
(16.8 to 29.4)
19.4
(15.7 to 23.8)
11.9
(6.9 to 19.6)
8.8
(6.0 to 12.7)
7.1
(4.4 to 11.4)
19.2
(12.0 to 29.3)
23.Secondary Outcome
Title Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Hide Description Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) <=1, swollen joint count (SJC28) <=1, hsCRP <=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) <=1 cm.
Time Frame Year 1 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.5
(26.3 to 35.1)
20.8
(18.4 to 23.4)
17.8
(12.7 to 24.2)
17.8
(14.2 to 22.0)
8.9
(4.8 to 16.1)
9.5
(6.6 to 13.5)
17.1
(12.6 to 22.8)
12.8
(7.1 to 22.0)
24.Secondary Outcome
Title Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Hide Description Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) <=1, swollen joint count (SJC28) <=1, hsCRP <=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) <=1 cm.
Time Frame Year 3 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.8
(26.6 to 35.4)
20.3
(18.0 to 22.9)
16.6
(11.7 to 22.9)
15.0
(11.7 to 19.1)
9.9
(5.5 to 17.3)
8.0
(5.4 to 11.9)
11.9
(8.2 to 17.0)
15.4
(9.0 to 25.0)
25.Secondary Outcome
Title Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Hide Description Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) <=1, swollen joint count (SJC28) <=1, hsCRP <=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) <=1 cm.
Time Frame Year 5 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26.5
(22.5 to 30.9)
17.7
(15.5 to 20.1)
13.6
(9.2 to 19.6)
14.2
(11.0 to 18.2)
6.9
(3.4 to 13.6)
7.3
(4.8 to 11.0)
5.2
(2.9 to 9.1)
15.4
(9.0 to 25.0)
26.Secondary Outcome
Title Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
Hide Description X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Time Frame Baseline, Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug in JADY with available baseline x-ray (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY) and Year 1 data. Zero participants analyzed, no data collected in this study or originating study.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
27.Secondary Outcome
Title Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
Hide Description X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Time Frame Baseline, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated with at least one dose of study drug in JADY with available baseline x-ray (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY) and Year 3 data. JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 387 343 137 301 0 0 203 0
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
1.30
(0.94 to 1.67)
1.64
(1.38 to 1.90)
1.13
(0.61 to 1.66)
1.13
(0.78 to 1.48)
1.20
(0.61 to 1.80)
28.Secondary Outcome
Title Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
Hide Description X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Time Frame Baseline, Year 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated with at least one dose of study drug in JADY with available baseline x-ray (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY) and Year 5 data. JAGS, JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 349 870 127 276 0 0 0 0
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
1.64
(1.18 to 2.09)
2.18
(1.85 to 2.51)
1.32
(0.69 to 1.96)
1.58
(1.15 to 2.02)
29.Secondary Outcome
Title Percentage of Participants With mTSS Change ≤0
Hide Description X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage.
Time Frame Year 1 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY. Year 1 data not available, zero participants analyzed due to no data collected in this study or originating study.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
30.Secondary Outcome
Title Percentage of Participants With mTSS Change ≤0
Hide Description X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage.
Time Frame Year 3 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY. JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 0 0 210 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
53.5
(48.7 to 58.2)
53.0
(50.0 to 56.0)
0.6
(0.1 to 3.3)
0.8
(0.3 to 2.4)
0
(0.0 to 1.8)
31.Secondary Outcome
Title Percentage of Participants With mTSS Change ≤0
Hide Description X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage.
Time Frame Year 5 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY. JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 0 0 210 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.7
(0.8 to 3.4)
0.6
(0.3 to 1.3)
0
(0.0 to 2.2)
0.5
(0.1 to 2.0)
0
(0.0 to 1.8)
32.Secondary Outcome
Title Change From Baseline of Originating Study in Joint Space Narrowing at Year 1
Hide Description X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.
Time Frame Baseline, Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated with at least one dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). Year 1 data not available, zero participants analyzed due to no data collected in this study or originating study.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
33.Secondary Outcome
Title Change From Baseline of Originating Study in Joint Space Narrowing at Year 3
Hide Description X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.
Time Frame Baseline, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated with at least one dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 387 943 137 301 0 0 203 0
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
0.45
(0.26 to 0.63)
0.72
(0.59 to 0.86)
0.54
(0.25 to 0.83)
0.44
(0.24 to 0.63)
0.52
(0.23 to 0.82)
34.Secondary Outcome
Title Change From Baseline of Originating Study in Joint Space Narrowing at Year 5
Hide Description X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing
Time Frame Baseline, Year 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated with at least one dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). JAGS, JADW, and JADA, zero participants analyzed due to no data collected in this study or originating study.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 349 870 127 276 0 0 0 0
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
0.59
(0.36 to 0.83)
1.00
(0.84 to 1.17)
0.68
(0.34 to 1.02)
0.60
(0.37 to 0.83)
35.Secondary Outcome
Title Change From Baseline of Originating Study in Duration of Morning Stiffness
Hide Description Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Time Frame Baseline, Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug in JADY and had evaluable morning stiffness data. Data not collected for JADX; zero participants analyzed.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 450 633 0 0 110 308 221 78
Mean (Standard Deviation)
Unit of Measure: minutes
-102.72  (155.27) -73.53  (144.22) -75.07  (139.00) -73.88  (149.55) -68.74  (148.34) -37.12  (61.34)
36.Secondary Outcome
Title Change From Baseline of Originating Study in Duration of Morning Stiffness
Hide Description Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Time Frame Baseline, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug in JADY and had evaluable morning stiffness data. Data not collected for JADX; zero participants analyzed.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 387 556 0 0 81 222 192 69
Mean (Standard Deviation)
Unit of Measure: minutes
-112.41  (159.78) -77.78  (141.01) -84.60  (127.85) -67.79  (154.05) -90.61  (147.70) -47.13  (52.97)
37.Secondary Outcome
Title Change From Baseline of Originating Study in Duration of Morning Stiffness
Hide Description Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Time Frame Baseline, Year 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug in JADY and had evaluable morning stiffness data. Data not collected for JADX; zero participants analyzed.
Arm/Group Title JADZ 4 Milligram (mg) Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 330 470 0 0 70 169 128 57
Mean (Standard Deviation)
Unit of Measure: minutes
-111.45  (164.74) -82.48  (137.23) -88.37  (146.73) -91.57  (163.88) -92.75  (125.39) -45.89  (60.43)
38.Secondary Outcome
Title Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Hide Description The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Time Frame Baseline, Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and had evaluable EQ-5D-5L data. EQ-5D-5L data was not collected during the JADA originating study, zero participants analyzed.
Arm/Group Title JADZ 4 Milligram (mg) Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 450 1088 171 383 108 305 221 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
UK 0.28  (0.26) 0.23  (0.24) 0.19  (0.26) 0.20  (0.23) 0.21  (0.22) 0.19  (0.24) 0.20  (0.26)
US 0.19  (0.18) 0.16  (0.17) 0.13  (0.18) 0.14  (0.16) 0.14  (0.15) 0.13  (0.16) 0.14  (0.18)
39.Secondary Outcome
Title Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Hide Description The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Time Frame Baseline, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and had evaluable EQ-5D-5L data. EQ-5D-5L data was not collected during the JADA originating study, zero participants analyzed.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 386 952 146 309 80 219 190 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
UK 0.33  (0.24) 0.24  (0.25) 0.20  (0.26) 0.21  (0.26) 0.21  (0.22) 0.22  (0.25) 0.24  (0.24)
US 0.23  (0.17) 0.17  (0.17) 0.15  (0.18) 0.15  (0.18) 0.14  (0.15) 0.15  (0.17) 0.17  (0.17)
40.Secondary Outcome
Title Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Hide Description The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Time Frame Baseline, Year 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and had evaluable EQ-5D-5L data. EQ-5D-5L data was not collected during the JADA originating study, zero participants analyzed.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 330 820 122 264 70 169 127 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
UK 0.35  (0.24) 0.26  (0.26) 0.19  (0.25) 0.20  (0.26) 0.21  (0.22) 0.22  (0.30) 0.25  (0.26)
US 0.24  (0.16) 0.18  (0.18) 0.13  (0.17) 0.14  (0.18) 0.15  (0.15) 0.15  (0.20) 0.18  (0.18)
41.Secondary Outcome
Title Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Hide Description The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
Time Frame Baseline, Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and had evaluable EQ-5D-5L data. EQ-5D-5L data was not collected during the JADA originating study, zero participants analyzed.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 450 1088 171 383 108 305 221 0
Mean (Standard Deviation)
Unit of Measure: millimeter (mm)
24.69  (28.50) 19.72  (28.17) 15.13  (26.78) 18.32  (26.35) 20.96  (24.53) 14.98  (30.21) 18.47  (27.31)
42.Secondary Outcome
Title Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Hide Description The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
Time Frame Baseline, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and had evaluable EQ-5D-5L data. EQ-5D-5L data was not collected during the JADA originating study, zero participants analyzed.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 386 952 146 309 80 219 190 0
Mean (Standard Deviation)
Unit of Measure: mm
28.48  (29.88) 22.10  (28.02) 16.29  (25.37) 16.48  (30.24) 23.53  (24.70) 18.79  (30.03) 21.45  (29.64)
43.Secondary Outcome
Title Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Hide Description The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
Time Frame Baseline, Year 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and had evaluable EQ-5D-5L data. EQ-5D-5L data was not collected during the JADA originating study, zero participants analyzed.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 330 820 122 264 70 169 127 0
Mean (Standard Deviation)
Unit of Measure: mm
31.13  (28.15) 23.93  (28.45) 13.82  (29.59) 19.34  (27.48) 26.19  (27.09) 23.57  (31.67) 27.31  (27.19)
44.Secondary Outcome
Title Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10
Hide Description The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame Year 1 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.6
(77.6 to 85.0)
75.3
(72.6 to 77.9)
68.6
(61.3 to 75.2)
69.9
(65.1 to 74.4)
52.5
(42.8 to 61.9)
50.7
(44.8 to 56.6)
73.3
(67.0 to 78.9)
60.3
(49.2 to 70.4)
45.Secondary Outcome
Title Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10
Hide Description The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame Year 3 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73.3
(68.8 to 77.3)
67.7
(64.8 to 70.5)
60.4
(52.8 to 67.4)
60.4
(55.3 to 65.3)
49.5
(40.0 to 59.1)
44.5
(38.8 to 50.4)
61.4
(54.7 to 67.8)
56.4
(45.4 to 66.9)
46.Secondary Outcome
Title Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10
Hide Description The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame Years 5 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61.6
(56.8 to 66.1)
61.1
(58.1 to 64.0)
51.5
(44.0 to 58.9)
54.6
(49.5 to 59.7)
44.6
(35.2 to 54.3)
35.4
(30.0 to 41.2)
21.9
(16.8 to 28.0)
56.4
(45.4 to 66.9)
47.Secondary Outcome
Title Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤ 2.8
Hide Description The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame Year 1 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
44.9
(40.2 to 49.7)
28.3
(25.7 to 31.2)
21.9
(16.3 to 28.7)
25.1
(21.0 to 29.8)
16.8
(10.8 to 25.3)
13.5
(10.0 to 18.1)
22.9
(17.7 to 29.0)
14.1
(8.1 to 23.5)
48.Secondary Outcome
Title Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤2.8
Hide Description The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame Year 3 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40.1
(35.5 to 44.9)
30.0
(27.3 to 32.8)
21.9
(16.3 to 28.7)
23.5
(19.4 to 28.1)
22.8
(15.7 to 31.9)
15.0
(11.2 to 19.7)
18.6
(13.9 to 24.4)
20.5
(13.0 to 30.8)
49.Secondary Outcome
Title Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤2.8
Hide Description The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame Year 5 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
33.9
(29.5 to 38.6)
25.0
(22.5 to 27.8)
19.5
(14.3 to 26.2)
22.4
(18.4 to 27.0)
15.8
(10.0 to 24.2)
12.8
(9.3 to 17.2)
8.1
(5.1 to 12.6)
19.2
(12.0 to 29.3)
50.Secondary Outcome
Title Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22
Hide Description The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Time Frame Year 1 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
89.7
(86.5 to 92.3)
81.4
(78.9 to 83.7)
78.7
(71.9 to 84.2)
75.4
(70.7 to 79.5)
74.3
(65.0 to 81.8)
69.3
(63.6 to 74.5)
80.0
(74.1 to 84.8)
48.7
(37.9 to 59.6)
51.Secondary Outcome
Title Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22
Hide Description The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Time Frame Year 3 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.4
(71.1 to 79.3)
70.4
(67.6 to 73.1)
64.5
(57.0 to 71.3)
63.4
(58.3 to 68.2)
56.4
(46.7 to 65.7)
54.4
(48.5 to 60.2)
68.1
(61.5 to 74.0)
47.4
(36.7 to 58.4)
52.Secondary Outcome
Title Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22
Hide Description The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Time Frame Year 5 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
65.2
(60.5 to 69.6)
58.5
(55.5 to 61.5)
51.5
(44.0 to 58.9)
51.4
(46.3 to 56.4)
50.5
(40.9 to 60.0)
39.4
(33.8 to 45.3)
20.0
(15.2 to 25.9)
39.7
(29.6 to 50.8)
53.Secondary Outcome
Title Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3
Hide Description

The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.

An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.

Time Frame Year 1 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
85.4
(81.7 to 88.5)
75.6
(72.9 to 78.1)
72.8
(65.6 to 78.9)
69.4
(64.5 to 73.9)
65.3
(55.7 to 73.9)
61.7
(55.8 to 67.2)
75.2
(69.0 to 80.6)
43.6
(33.1 to 54.6)
54.Secondary Outcome
Title Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3
Hide Description

The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.

An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.

Time Frame Year 3 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
72.6
(68.1 to 76.6)
64.8
(61.8 to 67.6)
61.5
(54.0 to 68.5)
58.5
(53.4 to 63.4)
50.5
(40.9 to 60.0)
47.8
(42.0 to 53.7)
63.8
(57.1 to 70.0)
38.5
(28.4 to 49.6)
55.Secondary Outcome
Title Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3
Hide Description

The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.

An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.

Time Frame Year 5 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
62.8
(58.0 to 67.3)
53.4
(50.3 to 56.4)
46.7
(39.4 to 54.3)
46.2
(41.1 to 51.3)
46.5
(37.1 to 56.2)
35.0
(29.6 to 40.9)
19.5
(14.7 to 25.4)
34.6
(25.0 to 45.7)
56.Secondary Outcome
Title Change From Baseline of Originating Study in Bone Erosion Score
Hide Description

The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet).

Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion.

LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.

Time Frame Baseline, Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated with at least one dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). Year 1 data not available, zero participants analyzed due to no data collected in this study or originating study.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
57.Secondary Outcome
Title Change From Baseline of Originating Study in Bone Erosion Score
Hide Description

The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet). Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion.

LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.

Time Frame Baseline, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated with at least one dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 387 943 137 301 0 0 203 0
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
0.85
(0.63 to 1.08)
0.92
(0.76 to 1.07)
0.59
(0.30 to 0.89)
0.69
(0.49 to 0.89)
0.68
(0.32 to 1.03)
58.Secondary Outcome
Title Change From Baseline of Originating Study in Bone Erosion Score
Hide Description

The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet). Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion.

LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.

Time Frame Baseline, Year 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated with at least one dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). JAGS, JADW, and JADA, zero participants analyzed due to no data collected in this study or originating study.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 349 870 127 276 0 0 0 0
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
1.04
(0.77 to 1.32)
1.18
(0.98 to 1.38)
0.65
(0.28 to 1.01)
0.98
(0.74 to 1.23)
59.Secondary Outcome
Title Healthcare Resource Utilization
Hide Description Number of visits to medical care providers related to treatment of Rheumatoid Arthritis (RA) outside of the clinical study. Reported here are healthcare consultations and emergency room consultations from end of originating study to end of participation in study JADY.
Time Frame Baseline up to 84 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and had access to and utilized healthcare services outside of the clinical study.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 451 1090 180 403 117 331 221 83
Measure Type: Number
Unit of Measure: consultations
Healthcare Consultations 3134 11108 2160 4573 2380 5410 717 749
Emergency Room Consultations 95 244 52 131 73 154 40 16
60.Secondary Outcome
Title Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11
Hide Description

SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.

The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score ≤11.

Time Frame Year 1 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.6
(77.6 to 85.0)
75.2
(72.5 to 77.8)
70.4
(63.1 to 76.8)
69.1
(64.2 to 73.6)
53.5
(43.8 to 62.9)
53.6
(47.7 to 59.5)
72.4
(66.0 to 78.0)
59.0
(47.9 to 69.2)
61.Secondary Outcome
Title Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11
Hide Description

SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.

The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score ≤11.

Time Frame Year 3 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73.3
(68.8 to 77.3)
67.8
(64.9 to 70.6)
60.9
(53.4 to 68.0)
62.3
(57.2 to 67.1)
48.5
(39.0 to 58.1)
44.5
(38.8 to 50.4)
60.0
(53.3 to 66.4)
57.7
(46.6 to 68.0)
62.Secondary Outcome
Title Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11
Hide Description

SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.

The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score ≤11.

Time Frame Year 5 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title JADZ 4 mg Baricitinib JADV 4 mg Baricitinib JADX 2 mg Baricitinib JADX 4 mg Baricitinib JADW 2 mg Baricitinib JADW 4 mg Baricitinib JAGS 4 mg Baricitinib JADA 4 mg Baricitinib
Hide Arm/Group Description:
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
2 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed 419 1034 169 366 101 274 210 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61.3
(56.6 to 65.9)
61.2
(58.2 to 64.1)
51.5
(44.0 to 58.9)
53.3
(48.2 to 58.3)
46.5
(37.1 to 56.2)
35.4
(30.0 to 41.2)
23.3
(18.1 to 29.5)
57.7
(46.6 to 68.0)
63.Secondary Outcome
Title Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3
Hide Description

SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.

The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of ≤3.3.

Time Frame Year 1 after entry into JADY
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.
Arm/Group Title