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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
History of Changes
  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:

U.S. FDA Resources

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 May 16, 2013