A Study for Japanese Participants With Rheumatoid Arthritis (RA)

Lilly

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: LY2127399 (Tabalumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01253226

13060

H9B-JE-BCDK (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 20 to 75 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 6 patient groups, including a placebo group

30 milligrams (mg) Tabalumab

Experimental group

Description:

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

Treatment:

Drug: LY2127399 (Tabalumab)

60 mg Tabalumab

Experimental group

Description:

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

Treatment:

Drug: LY2127399 (Tabalumab)

120 mg Tabalumab

Experimental group

Description:

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

Treatment:

Drug: LY2127399 (Tabalumab)

Placebo Q4W

Placebo Comparator group

Description:

Q4W for 20 weeks

Treatment:

Drug: Placebo

120 mg once every 2 weeks (Q2W) Tabalumab

Experimental group

Description:

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

Treatment:

Drug: LY2127399 (Tabalumab)

Placebo Q2W

Placebo Comparator group

Description:

Q2W for 20 weeks

Treatment:

Drug: Placebo