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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/NCT01215942
Registration number
NCT01215942
Ethics application status
Date submitted
5/10/2010
Date registered
7/10/2010
Date last updated
11/06/2018
Titles & IDs
Public title
An Open Label Study for Participants With Rheumatoid Arthritis
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Scientific title
A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA)
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Secondary ID [1]
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H9B-MC-BCDP
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Secondary ID [2]
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13419
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LY2127399
Experimental: 120 milligrams (mg) of LY2127399 - Given every 4 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 240 mg loading dose when initiating treatment.
Or
Given every 4 weeks for 168 weeks for those participants from Study BCDM.
Experimental: 90 mg LY2127399 - Given every 2 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 180 mg loading dose when initiating treatment.
Or
Given every 2 weeks for 168 weeks for those participants from Study BCDM.
Treatment: Drugs: LY2127399
Administered Subcutaneously
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period
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Assessment method [1]
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A TEAE was defined as an event that first occurred or worsened in severity on or after the date of the first injection and prior to study termination. AESI are infection, injection site reactions, malignancy, major adverse cardiovascular events (MACE), allergy and hypersensitivity, depression, suicide/self-injury and pregnancy. MACE were defined as 1 of the adjudicated events: cardiovascular death, Myocardial infarction (MI), stroke, hospitalization for unstable angina, hospitalization for heart failure, coronary revascularization procedure, peripheral revascularization procedure, cardiogenic shock due to MI, resuscitated sudden death, serious arrhythmia, hospitalization for hypertension, peripheral arterial event. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
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Timepoint [1]
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up to 84.4 weeks during treatment period
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Primary outcome [2]
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Percentage of Participants Developing Anti-LY2127399 Antibodies
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Assessment method [2]
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Participants with treatment-emergent anti-LY2127399 antibodies were participants who had any samples from baseline up to and through Week 72 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of =1:20). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants with anti-LY2127399 antibodies=(number of participants with treatment-emergent anti-LY2127399 antibodies / number of participants assessed)*100.
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Timepoint [2]
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Baseline through Weeks 4, 24, 48 and 72
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Primary outcome [3]
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Change From Baseline in Absolute B Cell Counts
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Assessment method [3]
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Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B cell count is the average of the values on or prior to the date of first injection of study treatment in preceding studies, including unscheduled visits. A positive or negative change indicated an increase or decrease, respectively, in B cell count.
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Timepoint [3]
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Baseline, Week 48
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Primary outcome [4]
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Change From Baseline in Serum Immunoglobulin (Ig) Levels
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Assessment method [4]
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Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP.
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Timepoint [4]
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Baseline, Week 48
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Secondary outcome [1]
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Percentage of Participants With American College of Rheumatology 20% Response (ACR20)
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Assessment method [1]
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ACR Responder Index is a Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responders: had =20% improvement from baseline in both 68 tender and 66 swollen joint counts and =20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants achieving ACR20 response=(number of ACR20 responders / number of participants treated) * 100. All participants who discontinue study treatment for any reason were defined as NR at that time point and going forward.
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Timepoint [1]
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Baseline through Weeks 12, 24 and 48
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Secondary outcome [2]
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Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)
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Assessment method [2]
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Timepoint [2]
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Baseline, 240 weeks
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Secondary outcome [3]
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Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR-28) Response
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Assessment method [3]
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Timepoint [3]
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Baseline through 240 weeks
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Secondary outcome [4]
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Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores
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Assessment method [4]
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Timepoint [4]
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Baseline, 240 weeks
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Secondary outcome [5]
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Change From Baseline in Tender Joint Count (68 Joint Count)
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Assessment method [5]
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Timepoint [5]
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Baseline, 240 weeks
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Secondary outcome [6]
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Change From Baseline in Swollen Joint Count (66 Joint Count)
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Assessment method [6]
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Timepoint [6]
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Baseline, 240 weeks
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Secondary outcome [7]
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Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]
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Assessment method [7]
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Timepoint [7]
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Baseline, 240 weeks
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Secondary outcome [8]
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Change From Baseline in Participants Global Assessment of Disease Activity (VAS)
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Assessment method [8]
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Timepoint [8]
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Baseline, 240 weeks
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Secondary outcome [9]
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Change From Baseline in Physicians Global Assessment of Disease Activity (VAS)
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Assessment method [9]
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Timepoint [9]
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Baseline, 240 weeks
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Secondary outcome [10]
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
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Assessment method [10]
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Timepoint [10]
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Baseline, 240 weeks
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Secondary outcome [11]
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Change From Baseline in CRP
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Assessment method [11]
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Timepoint [11]
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Baseline, 240 weeks
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Secondary outcome [12]
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American College of Rheumatology Percent Improvement (ACR-N)
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Assessment method [12]
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Timepoint [12]
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Baseline through 240 weeks
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Eligibility
Key inclusion criteria
- Have completed 24 weeks of participation in Study H9B-MC-BCDO or Study H9B-MC-BCDV, or
have completed 100 weeks of participation in Study H9B-MC-BCDM
- Woman must not be pregnant, breastfeeding, or become pregnant during the study
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Current presence of a serious disorder or illness
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2014
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Sample size
Target
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Accrual to date
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Final
1086
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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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. - Campbelltown
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Recruitment hospital [2]
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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
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Recruitment hospital [3]
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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. - Herston
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Recruitment hospital [4]
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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. - Malvern East
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Recruitment postcode(s) [1]
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2560 - Campbelltown
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Recruitment postcode(s) [2]
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04266-010 - Kogarah
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Recruitment postcode(s) [3]
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4029 - Herston
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Recruitment postcode(s) [4]
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3145 - Malvern East
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Recruitment outside Australia
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Funding & Sponsors
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Commercial sector/Industry
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Name
Eli Lilly and Company
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Ethics approval
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Summary
Brief summary
The primary purpose of this study is to help answer if LY2127399 is safe and effective during
long-term treatment in participants with Rheumatoid Arthritis.
This study is comprised of 2 periods:
Period 1: Unblinded treatment for up to 240 weeks for participants who enroll from Study
H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks
for participants who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002).
Period 2: 48-week post-treatment follow-up
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01215942
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Public notes
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Contacts
Principal investigator
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0
Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UCT/GMT - 5 hours, EST)
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0
Eli Lilly and Company
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01215942
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