A Study of LY2439821 in Rheumatoid Arthritis

Inclusion Criteria:

• Patients who have received 7 injections of LY2439821 subcutaneously in the 30-, 80-, or 180-mg dose cohorts, or 11 injections in the 240-mg loading dose/120-mg once-a-week maintenance dose group, and completed the follow-up period (14 weeks) in Study I1F-JE-RHAL.

• Ambulatory male or female patients.

  • Male patients: Agree to use a reliable method of birth control during the study including barrier contraceptives or a monogamous relationship with a partner who is not child bearing.
  • Female patients: Are women who test negative for pregnancy at the time of entry based on a pregnancy test and are not breast feeding. Women of child bearing potential must agree to use a reliable method of birth control during the study.
• Patients who have been treated with methotrexate (MTX) throughout Study I1F-JE-RHAL. Bucillamine, sulfasalazine and/or hydroxychloroquine are allowed to be administered in addition to MTX. In such a case, the patient needs to have been on a stable dose of the drug(s) throughout Study I1F-JE-RHAL and I1F-JE-RHAM.
• Patients who have given written informed consent approved by the Sponsor and the Institutional Review Board (IRB) governing the investigational site.

Exclusion Criteria:

• Patients who have had, during Study I1F-JE-RHAL, 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 this study.

• Patients who have any of the following abnormalities of clinical laboratory test results by Week 26 of Study I1F-JE-RHAL:

  • Absolute neutrophil count <1000 cells/μL;
  • Lymphocyte count <500 cells/μL; or
  • WBC count <2000/μL