Trial Review

Please note that the ANZCTR website will be unavailable from 10:00am until 11:00am (AEST) on Friday 27th June for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01721044




Registration number
NCT01721044
Ethics application status
Date submitted
1/11/2012
Date registered
2/11/2012
Date last updated
18/09/2019

Titles & IDs
Public title
A Moderate to Severe Rheumatoid Arthritis Study
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors
Secondary ID [1] 0 0
I4V-MC-JADW
Secondary ID [2] 0 0
14058
Universal Trial Number (UTN)
Trial acronym
RA-BEACON
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 - Placebo
Treatment: Drugs - Baricitinib
Treatment: Drugs - cDMARD

Placebo comparator: Placebo - Placebo administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 milligram (mg) orally once daily through Week 24.

Participants will continue to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Experimental: Baricitinib 2 mg - Baricitinib 2 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24.

Participants will continue to take background cDMARD therapy throughout study.

Experimental: Baricitinib 4 mg - Baricitinib 4 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24.

Participants will continue to take background cDMARD therapy throughout study.


Treatment: Drugs: Placebo
Administered orally

Treatment: Drugs: Baricitinib
Administered orally

Treatment: Drugs: cDMARD
Participants will continue to take background cDMARD therapy throughout study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg
Assessment method [1] 0 0
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 4 mg
Assessment method [1] 0 0
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 the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
Change From Baseline in the Disease Activity Score Based on a 28-Joint Count (DAS-28) High Sensitivity C-Reactive Protein (hsCRP) - Placebo Versus Baricitinib 4 mg
Assessment method [2] 0 0
DAS-28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), high sensitivity C-reactive protein (hsCRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-hsCRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission - Simplified Disease Activity Index (SDAI) =3.3 - Placebo Versus Baricitinib 4 mg
Assessment method [3] 0 0
The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score =3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants Achieving ACR20 Response - Placebo Versus Baricitinib 2 mg
Assessment method [4] 0 0
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 2 mg
Assessment method [5] 0 0
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 the HAQ-DI score. Total scores ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Timepoint [5] 0 0
Baseline, Week 12
Secondary outcome [6] 0 0
Change From Baseline in the DAS28 - hsCRP - Placebo Versus Baricitinib 2 mg
Assessment method [6] 0 0
DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: 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. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Timepoint [6] 0 0
Baseline, Week 12
Secondary outcome [7] 0 0
Percentage of Participants Achieving ACR/EULAR Remission - SDAI =3.3 - Placebo Versus Baricitinib 2 mg
Assessment method [7] 0 0
The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score =3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Percentage of Participants Achieving ACR20 Response
Assessment method [8] 0 0
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
Timepoint [8] 0 0
Week 24
Secondary outcome [9] 0 0
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Assessment method [9] 0 0
ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
Timepoint [9] 0 0
Week 12 and Week 24
Secondary outcome [10] 0 0
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Assessment method [10] 0 0
ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
Timepoint [10] 0 0
Week 12 and Week 24
Secondary outcome [11] 0 0
Change From Baseline in DAS28 - Erythrocyte Sedimentation Rate (ESR)
Assessment method [11] 0 0
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.
Timepoint [11] 0 0
Baseline, Week 12
Secondary outcome [12] 0 0
Change From Baseline in Clinical Disease Activity Index Score
Assessment method [12] 0 0
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.
Timepoint [12] 0 0
Baseline, Week 24
Secondary outcome [13] 0 0
Change From Baseline in Measures of SDAI Score
Assessment method [13] 0 0
The 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). A negative change from baseline indicates an improvement.
Timepoint [13] 0 0
Baseline, Week 24
Secondary outcome [14] 0 0
Percentage of Participants Achieving ACR/EULAR Remission - Boolean Remission
Assessment method [14] 0 0
The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 =1, SJC28 =1, acute phase response using C-reactive protein (milligrams per deciliter) =1, Patient's Global Assessment of Disease Activity using VAS (cm) =1.
Timepoint [14] 0 0
Week 24
Secondary outcome [15] 0 0
Change From Baseline in Duration of Participant Reported Outcome - Morning Joint Stiffness
Assessment method [15] 0 0
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 that day. 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.
Timepoint [15] 0 0
Baseline, Week 24
Secondary outcome [16] 0 0
Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)
Assessment method [16] 0 0
A participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no tiredness) and 10 representing (as bad as you can imagine). Participants rate their tiredness by selecting the one number that describes their worst level of tiredness during the past 24 hours. Total scores ranged from 0-10.
Timepoint [16] 0 0
Baseline, Week 24
Secondary outcome [17] 0 0
Change From Baseline in Worst Joint Pain NRS
Assessment method [17] 0 0
Participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no joint pain) and 10 representing (pain as bad as you can imagine). Participants rate their joint pain by selecting the one number that describes their worst level of joint pain during the past 24 hours. Total scores ranged from 0-10.
Timepoint [17] 0 0
Baseline, Week 24
Secondary outcome [18] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale Scores
Assessment method [18] 0 0
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.
Timepoint [18] 0 0
Baseline, Week 12, Week 24
Secondary outcome [19] 0 0
Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)
Assessment method [19] 0 0
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental \[MCS\] and physical \[PCS\]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status.
Timepoint [19] 0 0
Baseline, Week 12, Week 24
Secondary outcome [20] 0 0
Change From Baseline in European Quality of Life-5 Dimensions-5 Level Scores
Assessment method [20] 0 0
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. 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.
Timepoint [20] 0 0
Baseline, Week 12, Week 24
Secondary outcome [21] 0 0
Percentage Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
Assessment method [21] 0 0
The WPAI-RA participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. Using 6 questions, it yields four types of scores: absenteeism (work time missed), presenteeism (impairment at work), work productivity loss (overall work impairment), and activity impairment, with outcomes expressed as impairment percentages. Percentage work time missed absenteeism: Q2/(Q2+Q4)\*100, Percentage impairment while working presenteeism: Q5/10\*100; Percentage overall work impairment work productivity loss: Q2/(Q2+Q4)+\[(1-Q2/(Q2+Q4))x(Q5/10)\]\*100; Percentage activity impairment activity impairment: Q6/10\*100. Higher numbers indicate greater impairment and less productivity, that is, worse outcomes.
Timepoint [21] 0 0
Baseline, Week 12, Week 24
Secondary outcome [22] 0 0
Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib
Assessment method [22] 0 0
Timepoint [22] 0 0
Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.
Secondary outcome [23] 0 0
Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib
Assessment method [23] 0 0
Timepoint [23] 0 0
Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.

Eligibility
Key inclusion criteria
* Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) as defined by the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria for the Classification of RA
* Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints
* Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement = (greater than or equal to) 1 times the upper limit of normal (ULN)
* Have been treated at approved doses with at least 1 biologic tumor necrosis factor (TNF)- alpha inhibitor for at least 3 months and either:

* experienced insufficient efficacy or loss of efficacy
* experienced intolerance of such treatment
* Have had regular use of at least 1 conventional disease-modifying antirheumatic drugs (cDMARD) for at least the 12 weeks prior to study entry with a continuous, nonchanging dose for at least 8 weeks prior to study entry
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have received a biologic treatment for RA within 28 days of planned randomization; have received rituximab within 6 months of planned randomization
* Are currently receiving corticosteroids at doses > (greater than) 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization
* Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization
* Are currently receiving concomitant treatment with methotrexate (MTX), hydroxychloroquine, and sulfasalazine or combination of any 3 cDMARDs
* Have received any parenteral corticosteroid administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study
* Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization
* Have active fibromyalgia that, in the investigator's opinion, would make it difficult to appropriately assess RA activity for the purposes of this study
* Have a diagnosis of any systemic inflammatory condition other than RA, such as, but not limited to juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, active vasculitis or gout (participants with secondary Sjogren's syndrome are not excluded.)
* Have a diagnosis of Felty's syndrome
* Have had any major surgery within 8 weeks of study entry or will require major surgery during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the participant
* Have experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or have New York Heart Association stage IV heart failure
* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data
* Are largely or wholly incapacitated permitting little or no self care, such as, being bedridden or confined to a wheelchair
* Have an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of < (less than) 40 milliliter per minute per 1.73 m^2 (mL/min/1.73 m^2)
* Have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the ULN or the most recent available total bilirubin =1.5 times the ULN
* Have a history of, lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years
* Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination)
* Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection
* Have had symptomatic herpes zoster infection within 12 weeks prior to study entry
* Have a history of disseminated/complicated herpes zoster (eg, multidermatomal involvement, ophthalmic zoster, central nervous system involvement, postherpetic neuralgia)
* Are immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study
* Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
* Have screening laboratory test values, including thyroid-stimulating hormone (TSH), outside the reference range for the population or investigative site that, in the opinion of the investigator, pose an unacceptable risk for the participant's participation in the study
* Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator or the sponsor, are clinically significant and indicate an unacceptable risk for the participant's participation in the study (e.g. Fridericia's corrected QT interval >500 millisecond [msec])
* Have symptomatic herpes simplex at the time of study enrollment
* Have evidence of active or latent tuberculosis (TB)

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
1/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
527
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Kogarah
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Maroochydore
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Fitzroy
Recruitment postcode(s) [1] 0 0
04266-010 - Kogarah
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 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
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
Rosario
Country [21] 0 0
Argentina
State/province [21] 0 0
San Miguel De Tucuman
Country [22] 0 0
Austria
State/province [22] 0 0
Graz
Country [23] 0 0
Austria
State/province [23] 0 0
Vienna
Country [24] 0 0
Belgium
State/province [24] 0 0
Brussels
Country [25] 0 0
Belgium
State/province [25] 0 0
Mons
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Denmark
State/province [27] 0 0
Frederiksberg
Country [28] 0 0
Denmark
State/province [28] 0 0
Glostrup
Country [29] 0 0
Denmark
State/province [29] 0 0
Odense
Country [30] 0 0
France
State/province [30] 0 0
Montpellier
Country [31] 0 0
France
State/province [31] 0 0
Orleans
Country [32] 0 0
France
State/province [32] 0 0
Paris
Country [33] 0 0
France
State/province [33] 0 0
Rennes
Country [34] 0 0
France
State/province [34] 0 0
Tours
Country [35] 0 0
Germany
State/province [35] 0 0
Dresden
Country [36] 0 0
Germany
State/province [36] 0 0
Hamburg
Country [37] 0 0
Germany
State/province [37] 0 0
Heidelberg
Country [38] 0 0
Germany
State/province [38] 0 0
Würzburg
Country [39] 0 0
Greece
State/province [39] 0 0
Athens
Country [40] 0 0
Greece
State/province [40] 0 0
Heraklion
Country [41] 0 0
Greece
State/province [41] 0 0
Kifissia
Country [42] 0 0
Greece
State/province [42] 0 0
Larissa
Country [43] 0 0
Israel
State/province [43] 0 0
Ashkelon
Country [44] 0 0
Israel
State/province [44] 0 0
Beer Yaakov
Country [45] 0 0
Israel
State/province [45] 0 0
Haifa
Country [46] 0 0
Israel
State/province [46] 0 0
Jerusalem
Country [47] 0 0
Israel
State/province [47] 0 0
Kfar Saba
Country [48] 0 0
Israel
State/province [48] 0 0
Petah Tikva
Country [49] 0 0
Israel
State/province [49] 0 0
Tel Aviv
Country [50] 0 0
Italy
State/province [50] 0 0
Firenze
Country [51] 0 0
Italy
State/province [51] 0 0
Pisa
Country [52] 0 0
Italy
State/province [52] 0 0
Rome
Country [53] 0 0
Japan
State/province [53] 0 0
Chiba
Country [54] 0 0
Japan
State/province [54] 0 0
Fukuoka
Country [55] 0 0
Japan
State/province [55] 0 0
Hiroshima
Country [56] 0 0
Japan
State/province [56] 0 0
Hokkaido
Country [57] 0 0
Japan
State/province [57] 0 0
Japan
Country [58] 0 0
Japan
State/province [58] 0 0
Kagawa
Country [59] 0 0
Japan
State/province [59] 0 0
Kumamoto
Country [60] 0 0
Japan
State/province [60] 0 0
Nagasaki
Country [61] 0 0
Japan
State/province [61] 0 0
Okayama
Country [62] 0 0
Japan
State/province [62] 0 0
Saitama
Country [63] 0 0
Japan
State/province [63] 0 0
Tokyo
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Seoul
Country [65] 0 0
Mexico
State/province [65] 0 0
Guadalajara
Country [66] 0 0
Mexico
State/province [66] 0 0
Mexico City
Country [67] 0 0
Mexico
State/province [67] 0 0
Monterrey
Country [68] 0 0
Mexico
State/province [68] 0 0
San Luis Potosi
Country [69] 0 0
Netherlands
State/province [69] 0 0
Ubbergen
Country [70] 0 0
Poland
State/province [70] 0 0
Gdansk
Country [71] 0 0
Poland
State/province [71] 0 0
Nadarzyn
Country [72] 0 0
Poland
State/province [72] 0 0
Warsaw
Country [73] 0 0
Puerto Rico
State/province [73] 0 0
Caguas
Country [74] 0 0
Puerto Rico
State/province [74] 0 0
San Juan
Country [75] 0 0
Puerto Rico
State/province [75] 0 0
Santurce
Country [76] 0 0
Spain
State/province [76] 0 0
La Vila Joiosa
Country [77] 0 0
Spain
State/province [77] 0 0
Santander
Country [78] 0 0
Spain
State/province [78] 0 0
Sevilla
Country [79] 0 0
Spain
State/province [79] 0 0
Valencia
Country [80] 0 0
Switzerland
State/province [80] 0 0
Fribourg
Country [81] 0 0
Switzerland
State/province [81] 0 0
Lausanne
Country [82] 0 0
Switzerland
State/province [82] 0 0
Zürich
Country [83] 0 0
Turkey
State/province [83] 0 0
Edirne
Country [84] 0 0
Turkey
State/province [84] 0 0
Gaziantep
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Tyneside
Country [86] 0 0
United Kingdom
State/province [86] 0 0
West Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01721044