A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

Lilly

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Biological: LY2127399; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00785928

12409

H9B-MC-BCDH (Other Identifier)

Details and patient eligibility

About

To assess the efficacy of LY2127399 versus placebo using American College of Rheumatology (ACR)50 response scale at 24 weeks

Enrollment: 158 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have given written informed consent
• Women must not be at risk to become pregnant during study participation
• Diagnosis of Rheumatoid Arthritis (RA)
• Current, regular use of Methotrexate, at a stable dose
• Other criteria to be reviewed by study doctor

Exclusion criteria

• Use of excluded medications(reviewed by study doctor)
• Have not failed biologic tumor necrosis factor-alpha (TNF-α) inhibitor therapy
• Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation in the study
• Evidence of tuberculosis
• Have systemic inflammatory condition other than RA, such as juvenile RA, Crohn's disease, ulcerative colitis, psoriatic arthritis or seronegative spondyloarthropathy
• Other criteria to be reviewed by study doctor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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158 participants in 7 patient groups

Placebo

Experimental group

Treatment:

Drug: Placebo

1 mg LY2127399

Experimental group

Treatment:

Biological: LY2127399

3 mg LY2127399

Experimental group

Treatment:

Biological: LY2127399

10 mg LY2127399

Experimental group

Treatment:

Biological: LY2127399

30 mg LY2127399

Experimental group

Treatment:

Biological: LY2127399

60 mg LY2127399

Experimental group

Treatment:

Biological: LY2127399

120 mg LY2127399

Experimental group

Treatment:

Biological: LY2127399