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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01885078




Registration number
NCT01885078
Ethics application status
Date submitted
19/06/2013
Date registered
24/06/2013
Date last updated
25/04/2022

Titles & IDs
Public title
An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis
Scientific title
A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Rheumatoid Arthritis
Secondary ID [1] 0 0
I4V-MC-JADY
Secondary ID [2] 0 0
14060
Universal Trial Number (UTN)
Trial acronym
RA-BEYOND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Baricitinib
Treatment: Drugs - Placebo

Experimental: 4 milligram (mg) Baricitinib - 4 mg Baricitinib administered orally once daily.
Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label conventional disease-modifying antirheumatic drugs (cDMARD), nonsteroidal anti-inflammatory drug (NSAID), corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.

Experimental: 2 mg Baricitinib - 2 mg Baricitinib administered orally once daily.
Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.

Experimental: 2 mg Baricitinib Step-down - 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.
Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.

Experimental: 4 mg Baricitinib Step-down - 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.
Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.


Treatment: Drugs: Baricitinib
Administered orally

Treatment: Drugs: Placebo
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Experienced Adverse Events (AEs) or Serious AE
Timepoint [1] 0 0
Baseline through 84 Months
Secondary outcome [1] 0 0
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
Timepoint [1] 0 0
Year 1 after entry into JADY
Secondary outcome [2] 0 0
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
Timepoint [2] 0 0
Year 3 after entry into JADY
Secondary outcome [3] 0 0
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
Timepoint [3] 0 0
Year 5 after entry into JADY
Secondary outcome [4] 0 0
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
Timepoint [4] 0 0
Year 1 after entry into JADY
Secondary outcome [5] 0 0
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
Timepoint [5] 0 0
Year 3 after entry into JADY
Secondary outcome [6] 0 0
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
Timepoint [6] 0 0
Year 5 after entry into JADY
Secondary outcome [7] 0 0
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
Timepoint [7] 0 0
Year 1 after entry into JADY
Secondary outcome [8] 0 0
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
Timepoint [8] 0 0
Year 3 after entry into JADY
Secondary outcome [9] 0 0
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
Timepoint [9] 0 0
Year 5 after entry into JADY
Secondary outcome [10] 0 0
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) =3.2
Timepoint [10] 0 0
Year 1 after entry into JADY
Secondary outcome [11] 0 0
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) =3.2
Timepoint [11] 0 0
Year 3 after entry into JADY
Secondary outcome [12] 0 0
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) =3.2
Timepoint [12] 0 0
Year 5 after entry into JADY
Secondary outcome [13] 0 0
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Timepoint [13] 0 0
Year 1 after entry into JADY
Secondary outcome [14] 0 0
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Timepoint [14] 0 0
Year 3 after entry into JADY
Secondary outcome [15] 0 0
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Timepoint [15] 0 0
Year 5 after entry into JADY
Secondary outcome [16] 0 0
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of =3.2
Timepoint [16] 0 0
Year 1 after entry into JADY
Secondary outcome [17] 0 0
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of =3.2
Timepoint [17] 0 0
Year 3 after entry into JADY
Secondary outcome [18] 0 0
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of =3.2
Timepoint [18] 0 0
Year 5 after entry into JADY
Secondary outcome [19] 0 0
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
Timepoint [19] 0 0
Year 1 after entry into JADY
Secondary outcome [20] 0 0
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
Timepoint [20] 0 0
Year 3 after entry into JADY
Secondary outcome [21] 0 0
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
Timepoint [21] 0 0
Year 5 after entry into JADY
Secondary outcome [22] 0 0
Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Timepoint [22] 0 0
Year 1 after entry into JADY
Secondary outcome [23] 0 0
Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Timepoint [23] 0 0
Year 3 after entry into JADY
Secondary outcome [24] 0 0
Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Timepoint [24] 0 0
Year 5 after entry into JADY
Secondary outcome [25] 0 0
Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
Timepoint [25] 0 0
Baseline, Year 1
Secondary outcome [26] 0 0
Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
Timepoint [26] 0 0
Baseline, Year 3
Secondary outcome [27] 0 0
Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
Timepoint [27] 0 0
Baseline, Year 5
Secondary outcome [28] 0 0
Percentage of Participants With mTSS Change =0
Timepoint [28] 0 0
Year 1 after entry into JADY
Secondary outcome [29] 0 0
Percentage of Participants With mTSS Change =0
Timepoint [29] 0 0
Year 3 after entry into JADY
Secondary outcome [30] 0 0
Percentage of Participants With mTSS Change =0
Timepoint [30] 0 0
Year 5 after entry into JADY
Secondary outcome [31] 0 0
Change From Baseline of Originating Study in Joint Space Narrowing at Year 1
Timepoint [31] 0 0
Baseline, Year 1
Secondary outcome [32] 0 0
Change From Baseline of Originating Study in Joint Space Narrowing at Year 3
Timepoint [32] 0 0
Baseline, Year 3
Secondary outcome [33] 0 0
Change From Baseline of Originating Study in Joint Space Narrowing at Year 5
Timepoint [33] 0 0
Baseline, Year 5
Secondary outcome [34] 0 0
Change From Baseline of Originating Study in Duration of Morning Stiffness
Timepoint [34] 0 0
Baseline, Year 1
Secondary outcome [35] 0 0
Change From Baseline of Originating Study in Duration of Morning Stiffness
Timepoint [35] 0 0
Baseline, Year 3
Secondary outcome [36] 0 0
Change From Baseline of Originating Study in Duration of Morning Stiffness
Timepoint [36] 0 0
Baseline, Year 5
Secondary outcome [37] 0 0
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Timepoint [37] 0 0
Baseline, Year 1
Secondary outcome [38] 0 0
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Timepoint [38] 0 0
Baseline, Year 3
Secondary outcome [39] 0 0
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Timepoint [39] 0 0
Baseline, Year 5
Secondary outcome [40] 0 0
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Timepoint [40] 0 0
Baseline, Year 1
Secondary outcome [41] 0 0
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Timepoint [41] 0 0
Baseline, Year 3
Secondary outcome [42] 0 0
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Timepoint [42] 0 0
Baseline, Year 5
Secondary outcome [43] 0 0
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) =10
Timepoint [43] 0 0
Year 1 after entry into JADY
Secondary outcome [44] 0 0
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) =10
Timepoint [44] 0 0
Year 3 after entry into JADY
Secondary outcome [45] 0 0
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) =10
Timepoint [45] 0 0
Years 5 after entry into JADY
Secondary outcome [46] 0 0
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) = 2.8
Timepoint [46] 0 0
Year 1 after entry into JADY
Secondary outcome [47] 0 0
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) =2.8
Timepoint [47] 0 0
Year 3 after entry into JADY
Secondary outcome [48] 0 0
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) =2.8
Timepoint [48] 0 0
Year 5 after entry into JADY
Secondary outcome [49] 0 0
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.22
Timepoint [49] 0 0
Year 1 after entry into JADY
Secondary outcome [50] 0 0
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.22
Timepoint [50] 0 0
Year 3 after entry into JADY
Secondary outcome [51] 0 0
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.22
Timepoint [51] 0 0
Year 5 after entry into JADY
Secondary outcome [52] 0 0
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.3
Timepoint [52] 0 0
Year 1 after entry into JADY
Secondary outcome [53] 0 0
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.3
Timepoint [53] 0 0
Year 3 after entry into JADY
Secondary outcome [54] 0 0
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement =0.3
Timepoint [54] 0 0
Year 5 after entry into JADY
Secondary outcome [55] 0 0
Change From Baseline of Originating Study in Bone Erosion Score
Timepoint [55] 0 0
Baseline, Year 1
Secondary outcome [56] 0 0
Change From Baseline of Originating Study in Bone Erosion Score
Timepoint [56] 0 0
Baseline, Year 3
Secondary outcome [57] 0 0
Change From Baseline of Originating Study in Bone Erosion Score
Timepoint [57] 0 0
Baseline, Year 5
Secondary outcome [58] 0 0
Healthcare Resource Utilization
Timepoint [58] 0 0
Baseline up to 84 Months
Secondary outcome [59] 0 0
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =11
Timepoint [59] 0 0
Year 1 after entry into JADY
Secondary outcome [60] 0 0
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =11
Timepoint [60] 0 0
Year 3 after entry into JADY
Secondary outcome [61] 0 0
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =11
Timepoint [61] 0 0
Year 5 after entry into JADY
Secondary outcome [62] 0 0
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =3.3
Timepoint [62] 0 0
Year 1 after entry into JADY
Secondary outcome [63] 0 0
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =3.3
Timepoint [63] 0 0
Year 3 after entry into JADY
Secondary outcome [64] 0 0
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) =3.3
Timepoint [64] 0 0
Year 5 after entry into JADY
Secondary outcome [65] 0 0
Percentage of Participants With Relapse Event During the 96-Week Step-Down Period
Timepoint [65] 0 0
Week 0 through Week 96 of Step-down

Eligibility
Key inclusion criteria
- Have completed the final active treatment in study JADV (NCT01710358), JADZ
(NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS
(NCT02265705)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have significant uncontrolled cerebro-cardiovascular (eg, myocardial infarction [MI],
unstable angina, unstable arterial hypertension, severe heart failure, or
cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine,
hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed
during a previous baricitinib study that, in the opinion of the investigator, pose an
unacceptable risk to the participant if investigational product continues to be
administered

- Have a known hypersensitivity to baricitinib or any component of this investigational
product

- Had investigational product permanently discontinued at any time during a previous
baricitinib study

- Had temporary investigational product interruption at the final study visit of a
previous baricitinib study and, in the opinion of the investigator, this poses an
unacceptable risk for participation in the study

- Have any other condition that, in the opinion of the investigator, renders the
participant unable to understand the nature, scope, and possible consequences of the
study or precludes the participant from following and completing the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/11/2020
Sample size
Target
Accrual to date
Final
2877
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Combined Rheumatology Practice (CRP) - Kogarah
Recruitment hospital [4] 0 0
Coast Joint Care - Maroochydore
Recruitment hospital [5] 0 0
Emeritus Research - Camberwell
Recruitment hospital [6] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
4558 - Maroochydore
Recruitment postcode(s) [5] 0 0
3124 - Camberwell
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New Mexico
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
United States of America
State/province [27] 0 0
Wisconsin
Country [28] 0 0
Argentina
State/province [28] 0 0
Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Ciudad Autonoma Buenos Aires
Country [30] 0 0
Argentina
State/province [30] 0 0
Ciudad Autonoma De Buenos Aire
Country [31] 0 0
Argentina
State/province [31] 0 0
Santa Fe
Country [32] 0 0
Argentina
State/province [32] 0 0
Tucuman
Country [33] 0 0
Argentina
State/province [33] 0 0
Tucumán
Country [34] 0 0
Argentina
State/province [34] 0 0
Ciudad Autonoma de Buenos Aire
Country [35] 0 0
Argentina
State/province [35] 0 0
Cordoba
Country [36] 0 0
Argentina
State/province [36] 0 0
San Juan
Country [37] 0 0
Austria
State/province [37] 0 0
Steiermark
Country [38] 0 0
Austria
State/province [38] 0 0
Wien
Country [39] 0 0
Belgium
State/province [39] 0 0
Brussel
Country [40] 0 0
Belgium
State/province [40] 0 0
Oost-Vlaanderen
Country [41] 0 0
Belgium
State/province [41] 0 0
Vlaams Gewest
Country [42] 0 0
Belgium
State/province [42] 0 0
Genk
Country [43] 0 0
Belgium
State/province [43] 0 0
Mons
Country [44] 0 0
Brazil
State/province [44] 0 0
SP
Country [45] 0 0
Brazil
State/province [45] 0 0
São Paulo
Country [46] 0 0
Canada
State/province [46] 0 0
Alberta
Country [47] 0 0
Canada
State/province [47] 0 0
British Columbia
Country [48] 0 0
Canada
State/province [48] 0 0
Manitoba
Country [49] 0 0
Canada
State/province [49] 0 0
Ontario
Country [50] 0 0
Canada
State/province [50] 0 0
Quebec
Country [51] 0 0
Canada
State/province [51] 0 0
Saskatchewan
Country [52] 0 0
China
State/province [52] 0 0
Anhui
Country [53] 0 0
China
State/province [53] 0 0
Beijing
Country [54] 0 0
China
State/province [54] 0 0
Guangdong
Country [55] 0 0
China
State/province [55] 0 0
Guangzhou
Country [56] 0 0
China
State/province [56] 0 0
Hunan
Country [57] 0 0
China
State/province [57] 0 0
Jiangsu
Country [58] 0 0
China
State/province [58] 0 0
Jiangxi
Country [59] 0 0
China
State/province [59] 0 0
Shandong
Country [60] 0 0
China
State/province [60] 0 0
Shanghai
Country [61] 0 0
China
State/province [61] 0 0
Sichuan
Country [62] 0 0
China
State/province [62] 0 0
Yunnan
Country [63] 0 0
China
State/province [63] 0 0
Zhejiang
Country [64] 0 0
Croatia
State/province [64] 0 0
Osijek
Country [65] 0 0
Croatia
State/province [65] 0 0
Zagreb
Country [66] 0 0
Czechia
State/province [66] 0 0
Praha, Hlavní Mešto
Country [67] 0 0
Czechia
State/province [67] 0 0
Brno
Country [68] 0 0
Czechia
State/province [68] 0 0
Bruntal
Country [69] 0 0
Czechia
State/province [69] 0 0
Hustopece
Country [70] 0 0
Czechia
State/province [70] 0 0
Ostrava
Country [71] 0 0
Czechia
State/province [71] 0 0
Pardubice
Country [72] 0 0
Czechia
State/province [72] 0 0
Uherske Hradiste
Country [73] 0 0
Czechia
State/province [73] 0 0
Zlin
Country [74] 0 0
Denmark
State/province [74] 0 0
Hovedstaden
Country [75] 0 0
Denmark
State/province [75] 0 0
Syd
Country [76] 0 0
France
State/province [76] 0 0
Haute-Vienne
Country [77] 0 0
France
State/province [77] 0 0
Cahors CEDEX 9
Country [78] 0 0
France
State/province [78] 0 0
Chambray-lès-Tours
Country [79] 0 0
France
State/province [79] 0 0
Montpellier Cedex 5
Country [80] 0 0
France
State/province [80] 0 0
Nantes Cedex 1
Country [81] 0 0
France
State/province [81] 0 0
Orleans CEDEX 2
Country [82] 0 0
France
State/province [82] 0 0
Paris CEDEX 13
Country [83] 0 0
France
State/province [83] 0 0
Paris CEDEX 14
Country [84] 0 0
France
State/province [84] 0 0
Poitiers
Country [85] 0 0
France
State/province [85] 0 0
Rennes CEDEX 2
Country [86] 0 0
France
State/province [86] 0 0
Thionville
Country [87] 0 0
Germany
State/province [87] 0 0
Baden-Württemberg
Country [88] 0 0
Germany
State/province [88] 0 0
Bayern
Country [89] 0 0
Germany
State/province [89] 0 0
Nordrhein-Westfalen
Country [90] 0 0
Germany
State/province [90] 0 0
Sachsen-Anhalt
Country [91] 0 0
Germany
State/province [91] 0 0
Sachsen
Country [92] 0 0
Germany
State/province [92] 0 0
Berlin
Country [93] 0 0
Germany
State/province [93] 0 0
Hamburg
Country [94] 0 0
Greece
State/province [94] 0 0
Attiki
Country [95] 0 0
Greece
State/province [95] 0 0
Crete
Country [96] 0 0
Greece
State/province [96] 0 0
Larissa
Country [97] 0 0
Hungary
State/province [97] 0 0
Bacs-Kiskun
Country [98] 0 0
Hungary
State/province [98] 0 0
Bekes
Country [99] 0 0
Hungary
State/province [99] 0 0
Fejer
Country [100] 0 0
Hungary
State/province [100] 0 0
Pest
Country [101] 0 0
Hungary
State/province [101] 0 0
Szabolcs-Szatmar-Bereg
Country [102] 0 0
Hungary
State/province [102] 0 0
Budapest
Country [103] 0 0
Hungary
State/province [103] 0 0
Veszprem
Country [104] 0 0
India
State/province [104] 0 0
Andhra Pradesh
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to investigate the long-term safety and any side effects of
baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis
study.

The study provides 7 years of additional treatment with baricitinib.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01885078
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries