A Study for Japanese Participants With Rheumatoid Arthritis (RA)

NCT ID: NCT01253226

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-08-31

Brief Summary

This study will evaluate the safety and tolerability of multiple doses of LY2127399 (tabalumab) in Japanese participants with RA. The study consists of a 20-week treatment period. All participants will be followed for up to 12 weeks after the last study drug administration.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

30 milligrams (mg) Tabalumab

30 mg tabalumab every 4 weeks (Q4W) for 20 weeks (6 doses of study drug)

Group Type: EXPERIMENTAL

LY2127399 (Tabalumab)

Intervention Type: DRUG

Administered subcutaneously

60 mg Tabalumab

60 mg tabalumab Q4W for 20 weeks (6 doses of study drug)

Group Type: EXPERIMENTAL

LY2127399 (Tabalumab)

Intervention Type: DRUG

Administered subcutaneously

120 mg Tabalumab

120 mg tabalumab Q4W for 20 weeks (6 doses of study drug)

Group Type: EXPERIMENTAL

LY2127399 (Tabalumab)

Intervention Type: DRUG

Administered subcutaneously

Placebo Q4W

Q4W for 20 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered subcutaneously

120 mg once every 2 weeks (Q2W) Tabalumab

Initial loading dose of 240 mg tabalumab followed by 120 mg Q2W for 20 weeks (10 doses of study drug)

Group Type: EXPERIMENTAL

LY2127399 (Tabalumab)

Intervention Type: DRUG

Administered subcutaneously

Placebo Q2W

Q2W for 20 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered subcutaneously

Interventions

LY2127399 (Tabalumab)

Administered subcutaneously

Intervention Type: DRUG

Placebo

Administered subcutaneously

Intervention Type: DRUG

Other Intervention Names

LY2127399; Tabalumab

Eligibility Criteria

Inclusion Criteria

• Have given written informed consent
• Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
• Diagnosis of RA
• Active RA
• Current, regular use of Methotrexate, at a stable dose
• Body weight between 40 and 105 kilograms (kg), inclusive

Exclusion Criteria

• Use of excluded medications (reviewed by study doctor)
• Have medical findings which, in the opinion of the study doctor, put participant at an unacceptable risk for participation in the study
• Have had recent or ongoing infection which, in the opinion of the study doctor put participant at an unacceptable risk for participation
• Evidence of tuberculosis
• Have systemic inflammatory condition other than RA

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT - 5 hours, EST )

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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.

Aichi, , 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.

Chiba, , 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.

Fukui, , 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.

Gunma, , 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.

Hyōgo, , 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.

Ibaraki, , 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.

Kanagawa, , 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.

Miyagi, , 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.

Osaka, , 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, , Japan

Countries

Japan

Other Identifiers

H9B-JE-BCDK

Identifier Type: OTHER

Identifier Source: secondary_id

13060

Identifier Type: -

Identifier Source: org_study_id