An Open Label Extension Study in Patients With Rheumatoid Arthritis

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2009/091/000765
• Date of registration: 24-09-2009
• Prospective Registration: No
• 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
• Phase: Phase 2

Countries of recruitment

India

Contacts

• Name: Anil Seth

• Name: Anil Seth

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:

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 long-term efficacy of LY2127399 as assessed by the EULAR28Timepoint: 48 weeks

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 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

Ethics review

Status: Approved
Approval date:
Contact:

IEC, CSM Medical University

Status: Approved
Approval date:
Contact:

IEC, Jehangir Hospital

Status: Approved
Approval date:
Contact:

IEC, Krishna Institute of Medical Sciences