An Open Label Extension Study in Participants With Rheumatoid Arthritis

Lilly

Status and phase

Completed

Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Biological: LY2127399

Study type

Interventional

Funder types

Industry

Identifiers

CTRI/2009/091/000765 (Registry Identifier)

H9B-MC-BCDI (Other Identifier)

11768

Details and patient eligibility

About

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

Enrollment

182 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)

Exclusion criteria

Have had, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any safety event, [including having a recent, ongoing, or serious infection, a serious drug reaction, or any adverse event (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 H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any drug not allowed by the study protocol including unapproved drugs, biologic disease-modifying anti-rheumatic drugs (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.