A Safety and Pharmacokinetics Study in Participants With Rheumatoid Arthritis

Lilly

Status and phase: Completed; Phase 2; Phase 1

Conditions: Arthritis, Rheumatoid

Treatments: Drug: LY2189102; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00380744

8705

H9C-MC-BBDE (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to examine the safety and efficacy of this antibody in participants with rheumatoid arthritis.

Part A of the study is an initial dose escalation phase

Part B of the study is a randomized allocation of the entire dosing group to parallel treatment assignments

Enrollment: 121 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of rheumatoid arthritis
• regular use of methotrexate
• active rheumatoid arthritis

Exclusion criteria

• Juvenile Rheumatoid Arthritis
• evidence of tuberculosis
• women who are pregnant or become pregnant during study, or are breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 5 patient groups, including a placebo group

Part A LY2189102 0.1 mg/kg/wk

Experimental group

Description:

Part A: 2 times (x) 0.1 milligrams/kilogram/week (mg/kg/wk) Loading dose, then 0.1 mg/kg/wk) X 4 weeks (wks), intravenous (IV) Part B: 2 x 0.02 mg/kg/wk Loading dose, then 0.02 mg/kg/wk X 4 wks, IV

Treatment:

Drug: LY2189102

Part A LY2189102 0.3 mg/kg/wk

Experimental group

Description:

Part A: 2 x 0.3 mg/kg/wk Loading dose, then 0.3 mg/kg/wk X 4 wks, IV Part B: 2 x 0.15 mg/kg/wk Loading dose, then 0.15 mg/kg/wk X 4 wks, IV

Treatment:

Drug: LY2189102

Part A LY2189102 1.0 mg/kg/wk

Experimental group

Description:

Part A: 2 x 1.0 mg/kg/wk Loading dose, then 1.0 mg/kg/wk X 4 wks, IV Part B: 2 x 1.0 mg/kg/wk Loading dose, then 1.0 mg/kg/wk X 4 wks, IV

Treatment:

Drug: LY2189102

Part A LY2189102 2.5 mg/kg/wk

Experimental group

Description:

Part A: 2 x 2.5 mg/kg/wk Loading dose, then 2.5 mg/kg/wk X 4 wks, IV Part B: 2 x 2.5 mg/kg/wk Loading dose, then 2.5 mg/kg/wk X 4 wks, IV

Treatment:

Drug: LY2189102

Placebo

Placebo Comparator group

Description:

IV, once weekly x 4 wks

Treatment:

Drug: placebo