An Open Label Extension Study in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00837811
First received: February 3, 2009
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections for 48 weeks in patients with Rheumatoid Arthritis


Condition Intervention Phase
Rheumatoid Arthritis
Biological: LY2127399
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Rheumatoid Arthritis.

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Clinical laboratory evaluations (including hematology, clinical chemistry and urinalysis) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the long-term efficacy of LY2127399 as assessed by the individual components of the ACR Core set, as well as ACR20, ACR50, ACR70, and ACR-N [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • To evaluate the long-term efficacy of LY2127399 as assessed by the DAS28 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • To evaluate the long-term efficacy of LY2127399 as assessed by the EULAR28 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 183
Study Start Date: February 2009
Study Completion Date: January 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2127399 Biological: LY2127399
60 mg (with potential for dose escalation to 120 mg) subcutaneously every 4 weeks for 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • Enrollment in any other clinical trial involving off-label use of an investigational drug or device, or enrollment in any other type of medical research.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837811

  Show 62 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UCT/GMT-5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00837811     History of Changes
Other Study ID Numbers: 11768, H9B-MC-BCDI, CTRI/2009/091/000765
Study First Received: February 3, 2009
Last Updated: January 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014