A PHASE 3B, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF LY2127399 IN PATIENTS WITH RHEUMATOID ARTHRITIS (RA)

Recruitment & Eligibility

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. HAVE COMPLETED 24 WEEKS OF PARTICIPATION IN STUDY BCDO OR STUDY BCDV, OR HAVE COMPLETED 100 WEEKS OF PARTICIPATION IN STUDY BCDM.
2. WOMEN MUST NOT BE PREGNANT, BREASTFEEDING, OR AT RISK TO BECOME PREGNANT DURING STUDY PARTICIPATION. FEMALE PATIENTS OF CHILDBEARING POTENTIAL, MUST TEST NEGATIVE FOR PREGNANCY AT THE TIME OF ENROLLMENT AND AGREE TO USE A RELIABLE METHOD OF BIRTH CONTROL OR REMAIN ABSTINENT DURING THE STUDY OR FOR AT LEAST 8 WEEKS FOLLOWING THE LAST DOSE OF STUDY DRUG, WHICHEVER IS LONGER, OR, MUST BE A FEMALE OF NON-CHILDBEARING POTENTIAL, DEFINED AS:
WOMEN WHO HAVE HAD SURGICAL STERILIZATION (HYSTERECTOMY OR BILATERAL OOPHORECTOMY OR TUBAL LIGATION).
- OR -
WOMEN WHO ARE ≥ 60 YEARS OF AGE.
-OR-
WOMEN ≥ 40 AND <60 YEARS OF AGE WHO HAVE HAD A CESSATION OF MENSES FOR AT LEAST 12 MONTHS AND A FOLLICLE STIMULATING HORMONE (FSH) TEST CONFIRMING NON-CHILDBEARING POTENTIAL (≥ 40 mlU/mL).
3. HAVE GIVEN WRITTEN INFORMED CONSENT APPROVED BY LILLY OR ITS REPRESENTATIVE AND THE INSTITUTIONAL REVIEW BOARD/ETHICAL REVIEW BOARD (IRB/ERB) GOVERNING THE SITE.

Exclusion Criteria

1. PRESENCE OF SIGNIFICANT UNCONTROLLED CEREBRO-CARDIOVASCULAR (FOR EXAMPLE: MYOCARDIAL INFARCTION [MI], UNSTABLE ANGINA, UNSTABLE ARTERIAL HYPERTENSION, SEVERE HEART FAILURE OR CEREBROVASCULAR ACCIDENT), RESPIRATORY, HEPATIC, RENAL, GASTROINTESTINAL, ENDOCRINE, HEMATOLOGIC OR NEUROPSYCHIATRIC DISORDERS OR ABNORMAL LABORATORY VALUES AT BASELINE THAT IN THE OPINION OF THE INVESTIGATOR POSE AN UNACCEPTABLE RISK TO THE PATIENT IF STUDY DRUG WOULD BE ADMINISTERED.
2. HAVE ANY OTHER CONDITION THAT RENDERS THE PATIENT UNABLE TO UNDERSTAND THE NATURE, SCOPE AND POSSIBLE CONSEQUENCES OF THE STUDY OR PRECLUDES THE PATIENT FROM FOLLOWING AND COMPLETING THE PROTOCOL, IN OPINION OF THE INVESTIGATOR.
3. ARE INVESTIGATOR SITE PERSONNEL DIRECTLY AFFILIATED WITH THIS STUDY AND/OR THEIR IMMEDIATE FAMILIES. IMMEDIATE FAMILY IS DEFINED AS A SPOUSE, PARENT, CHILD, OR SIBLING, WHETHER BIOLOGICAL OR LEGALLY ADOPTED.
4. ARE EMPLOYEES OF LILLY OR OF THIRD-PARTY ORGANIZATIONS (TPOs) INVOLVED IN STUDY WHO REQUIRE EXCLUSION OF THEIR EMPLOYEES.
INVSTIGATORS MAY CONTACT LILLY OR REPRESENTATIVE WITH QUESTIONS REGARDING INCLUSION AND EXCLUSION CRITERIA.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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