A Study of LY2439821 in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

An Open-Label Extension Study to Evaluate Safety and Tolerability of Multiple Subcutaneous Doses of LY2439821 in Japanese Patients With Rheumatoid Arthritis on Concomitant Methotrexate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236118
• Other study ID #: 13625
• Secondary ID: I1F-JE-RHAM
• Status: Completed
• Phase: Phase 1
• First received: November 4, 2010
• Last updated: February 12, 2013
• Start date: December 2010
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of LY2439821 subcutaneously administered for 48 weeks in Japanese patients with rheumatoid arthritis who have completed Study I1F-JE-RHAL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• LY2439821
Administered subcutaneously

Locations

Country	Name	City	State
Japan	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Fukuoka
Japan	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hyogo
Japan	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nagasaki
Japan	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Niigata
Japan	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Okayama
Japan	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with clinically significant effects		Up to 56 weeks	Yes