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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 29 June 2014
Main ID:  CTRI/2009/091/000765
Date of registration: 24-09-2009
Primary sponsor: Eli Lilly and Company
Public title: An Open Label Extension Study in Patients With Rheumatoid Arthritis
Scientific title: An Open Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Rheumatoid Arthritis
Date of first enrolment: 09-02-2009
Target sample size: 0
Recruitment status: Completed
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=940
Study type:  Interventional
Study design:  Single Arm Trial
Method of generating randomization sequence:Random Number Table Method of allocation concealment:Not Applicable Blinding and masking:Open Label
 
Countries of recruitment
Contacts
Key inclusion & exclusion criteria
Inclusion criteria: -Have given written informed consent
-Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
-Have participated in either Study BCDG or Study BCDH

Exclusion criteria: -Have had, during Study BCDG or Study BCDH, any safety event,(including having a recent, ongoing, or serious infection, a serious drug reaction, or any AE that caused discontinuation from treatment) that in the opinion of the investigator poses an unacceptable risk to participation in the study.
-Have received, during Study BCDG or Study BCDH, any drug not allowed by the study protocol including unapproved drugs, biologic DMARDs, or live vaccines.


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Intervention1: LY2127399: 60 mg subcutaneously every 4 weeks for 48 weeks
Control Intervention1: Nil: Nil
Primary Outcome(s)
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Timepoint: 48 weeks
Secondary Outcome(s)
To evaluate the impact of long term administration of LY2127399 on patient reported outcomes as measured by the Medical Outcomes Study 36-item Short Form Health Survey (SF-36)Timepoint: 48 weeks
To evaluate the impact of long term administration of LY2127399 on patient-reported outcomes as measured by the Functional Assessment of Chronic Illness Therapy(FACIT)Timepoint: 48 weeks
To evaluate the long-term efficacy of LY2127399 as assessed by the DAS28Timepoint: 48 weeks
To evaluate the long-term efficacy of LY2127399 as assessed by the EULAR28Timepoint: 48 weeks
To evaluate the long-term efficacy of LY2127399 as assessed by the individual components of the ACR Core setTimepoint: 48 weeks
Secondary ID(s)
H9B-MC-BCDI
NCT00837811
Source(s) of Monetary Support
Eli Lilly and Company
Secondary Sponsor(s)
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