A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNFα Inhibitor Therapy

Lilly

Status and phase: Completed; Phase 2

Conditions: Arthritis, Rheumatoid

Treatments: Biological: LY2127399; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00689728

11351 (Registry Identifier)

H9B-MC-BCDG (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to explore whether LY2127399 is effective in relieving signs and symptoms of rheumatoid arthritis (RA) in patients with a history of inadequate response or intolerance to at least 1 Tumor Necrosis Factor-Alpha (TNFα) inhibitor therapy. Examples of these TNFα inhibitor therapies that are currently on the market include Enbrel® (etanercept), Remicade® (infliximab), and Humira® (adalimumab).

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have given written informed consent approval
• Women must not be at risk to become pregnant during study participation
• Diagnosis of Rheumatoid Arthritis
• Active Rheumatoid Arthritis
• Current, regular use of Methotrexate, at a stable dose
• Have been on at least 1 biologic tumor necrosis factor-alpha (TNFα) inhibitor therapy and either failed or were intolerant to treatment
• Other criteria to be reviewed by study doctor

Exclusion criteria

• Use of excluded medications (reviewed by study doctor)
• Have medical findings which, in the opinion of the study doctor, put patient at an unacceptable risk for participation in the study
• Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation
• Evidence of tuberculosis
• Have systemic inflammatory condition other than rheumatoid arthritis (RA), such as juvenile RA, seronegative spondyloarthropathy, Crohn's disease, ulcerative colitis, or psoriatic arthritis.
• Other criteria to be reviewed by study doctor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 3 patient groups, including a placebo group

30 milligram (mg) LY2127399

Experimental group

Description:

Double-blind Treatment: 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: At Week 16 primary endpoint, participants without at least 20% improvement in either tender or swollen joint counts based on 28 joints, could receive an additional (unblinded) 30 minute infusion of LY2127399 80 mg or remain on initial randomized treatment up to Week 24. Follow-up: Optional visits beyond Week 24, if needed, to assess safety including B cell count recovery.

Treatment:

Biological: LY2127399

80 mg LY2127399

Experimental group

Description:

Double-blind Treatment: 80 mg LY2127399 administered as a single IV infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: At Week 16 primary endpoint, participants without at least 20% improvement in either tender or swollen joint counts based on 28 joints, could receive an additional (unblinded) 30 minute infusion of LY2127399 80 mg or remain on initial randomized treatment up to Week 24. Follow-up: Optional visits beyond Week 24, if needed, to assess safety including B cell count recovery.

Treatment:

Biological: LY2127399

Placebo

Placebo Comparator group

Description:

Double-blind Treatment: Placebo comparator administered as a single IV infusion over 30 minutes at 0, 3, and 6 weeks. Rescue: At Week 16 primary endpoint, participants without at least 20% improvement in either tender or swollen joint counts based on 28 joints could receive an additional (unblinded) 30 minute infusion of LY2127399 80 mg or remain on same initial randomized treatment up to Week 24. Follow-Up: Optional visits beyond Week 24, if needed, to assess safety including B cell count recovery.

Treatment:

Drug: Placebo