A Phase 3 Study in Rheumatoid Arthritis

• Register: EUCTR
• Last refreshed on: 8 March 2021
• Main ID: EUCTR2012-003686-17-GR
• Date of registration: 16/01/2014
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Phase 3 Study in Rheumatoid Arthritis
• Scientific title: A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND
• Date of first enrolment: 18/03/2014
• Target sample size: 3350
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003686-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: different dosage of the same product (2mg vs 4 mg) Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly and Company

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

Inclusion criteria:
• Have completed the final active treatment study visit in Study I4V-MC-JADV, I4V-MC-JADZ, I4V-MC-JADX,I4V-MC-JADW, I4V-MC-JADA, or I4V-MC-JAGS.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

Exclusion criteria:
Patients will be excluded from the study if they meet any of the following criteria:
• have significant uncontrolled cerebro-cardiovascular, 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 patient 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 the patient’s participation in the study
• have any other condition that, in the opinion of the investigator, renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol
• are females of childbearing potential who do not agree to use 2 forms of highly effective birth control when engaging in sexual intercourse while enrolled in the study and for at least 28 days following the last dose of investigational product
• are males who do not agree to use 2 forms of highly effective birth control while engaging in sexual intercourse with female partners of childbearing potential while enrolled in the study and for at least 28 days following the last dose of investigational product



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Rheumatoid arthritis
MedDRA version: 21.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
Pharmaceutical Form: Tablet
INN or Proposed INN: baricitinib
CAS Number: 1187594-09-7
Current Sponsor code: LY3009104
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
Pharmaceutical Form: Tablet
INN or Proposed INN: baricitinib
CAS Number: 1187594-09-7
Current Sponsor code: LY3009104
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: The primary objective of the study is to evaluate the long-term safety and tolerability of baricitinib.

Timepoint(s) of evaluation of this end point: a) All study visits.
b) All study visits except Visits 1, 2, 5 and 801.
c) All study visits.

Secondary Objective: To evaluate in patients initially randomized to receive baricitinib in the
originating study, the effect of long-term administration of baricitinib on
the progression of structural joint damage, joint space narrowing and
bone erosion score, duration of morning stiffness, and changes in the
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) scores and in
healthcare resource utilization.To determine if treatment with baricitinib
2 mg QD maintains the low disease activity level achieved with the 4-mg
QD dose on patients who maintain a CDAI score of =10 and Time to
relapse after randomization to the baricitinib 2-mg and 4-mg QD doses.

Primary end point(s): a) Proportion of patients experiencing Treatment emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) over long term follow-up.
b) Temporary study drug interruptions and/or permanent study drug discontinuations over the long term follow-up
c) Vital signs and laboratory evaluations (including chemistry and hematology)

Secondary Outcome(s)

Secondary end point(s): a)Proportion of patients who maintain an improvement of 20, 50 or 70 percent, respectively, in the American College of Reumatology criteria (ACR20, ACR50 and ACR70)
b)Proportion of patients who maintain a DAS28-high-sensitivity C-reactive protein (hsCRP)/DAS28-erythrocyte sedimentation rate (ESR)=3.2, DAS28-hsCRP<2.6,DAS28-ESR<2.6,CDAI=10 and CDAI=2.8 , SDAI=11 and SDAI=3.3, ACR/EULAR remission according to Boolean definition and Health Assessment Questionnaire Disability Index (HAQ-DI) improvement of =0.22 and =0.3
c) Structural joint damage as measured by modified Total Sharp Score (mTSS) [van der Heijde method])
d) Proportion of patients with mTSS change =0
e) Joint space narrowing and bone erosion score
f) Duration of morning stiffness
g) European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) scores and Healthcare resource utilization
h) Proportion of patients who maintain a CDAI score of =10 from
Studies JADV, JADW, and JAGX after 3 months of treatment with
baricitinib 2 mg QD and with patients continuing treatment with the 4-
mg QD dose
i) Time to relapse (CDAI score >10 from Studies JADV, JADW, and JADX)
after randomization to the baricitinib 2-mg and 4-mg QD doses

Timepoint(s) of evaluation of this end point: a) Change from Month 6 (of the originating study) through each 12 months of treatment
b) same as a)
c) Change from baseline of originating study through each 12 months of treatment
d) same as c)
e) same as c)
f) Change from baseline in duration of morning stiffness through each 12 months of treatment
g) Change from baseline through each 12 months of treatment
h)All study visits
i) All study visits

Secondary ID(s)

2012-003686-17-IT

I4V-MC-JADY

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 18/03/2014
Contact: