A Study of Japanese Rheumatoid Arthritis Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: LY2127399

Study type: Interventional

Funder types: Industry

Identifiers

NCT01253291

H9B-JE-BCDL (Other Identifier)

13417

Details and patient eligibility

About

The objective of this study is to evaluate the safety and tolerability of 48 weeks subcutaneous (SC) dosing with LY2127399 for participants who have participated in a prior LY2127399 clinical study. At the end of the 48-week treatment period, participants will participate in a 24-week follow-up period. Additional follow up after Week 72 may continue to assess B-cell recovery.

Enrollment: 26 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Have given written informed consent
• Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
• Must have completed treatment and 12 week follow up period in prior LY2127399 study NCT01253226 [Study H9B-JE-BCDK (BCDK)]

Exclusion criteria

• Have had any safety event during the previous LY2127399 (BCDK) study that participants participated in
• Have received, during previous study (BCDK), any drugs prohibited in the study protocol which includes unapproved drugs, live vaccines, or any biologic or non-biologic disease-modifying anti-rheumatic drug (DMARD) except for, methotrexate (MTX), hydroxychloroquine, sulfasalazine or bucillamine

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

30mg/120 mg LY2127399

Experimental group

Description:

Participants in the 30 milligrams (mg) every 4 weeks arm of the lead-in study will receive 30 mg every 4 weeks until the safety of the 120 mg every 4 weeks dose is confirmed in the lead-in study.

Treatment:

Drug: LY2127399

120 mg LY2127399

Experimental group

Description:

Participants in the 60 mg every 4 weeks, 120 mg every 4 weeks and 120 mg every 2 weeks arms of the lead-in study will receive 120 mg every 4 weeks as these participants will enroll in this study after the safety of the 120 mg every 4 weeks dose in the lead-in study is confirmed.

Treatment:

Drug: LY2127399