An Open Label Extension Study in Patients With Rheumatoid Arthritis

To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections for 48 weeks in patients with rheumatoid arthritis.

Official Title

An Open Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Rheumatoid Arthritis

Conditions

• Rheumatoid arthritis

Study Type

Interventional

Study Design

Treatment, Open Label, Single Group Assignment, Safety Study

Further Details

Primary outcome measures

• Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
  [ Time Frame: 48 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
  [ Time Frame: 48 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: 48 weeks ]
  [ Designated as safety issue: No ]
• To evaluate the long-term efficacy of LY2127399 as assessed by the DAS28
  [ Time Frame: 48 weeks ]
  [ Designated as safety issue: No ]
• To evaluate the long-term efficacy of LY2127399 as assessed by the EULAR28
  [ Time Frame: 48 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: 48 weeks ]
  [ Designated as safety issue: No ]

Study arms and assigned interventions

1. LY2127399: Experimental
   • Biological: LY2127399 60 mg subcutaneously every 4 weeks for 48 weeks

Study Start

February 2009 – February 2011

Eligibility & Criteria

• Ages eligible for study: 18 years and older
• Genders eligible for study: Both
• Accepts healthy volunteers: No

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.

Total Enrolment

160

Contact Details

Eli Lilly and Company
1 317 615 4559 or 1 8777 285 4559