Rheumatoid Arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients will be male and female aged =18 years of age with a diagnosis of moderately to severely active adult onset RA • Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years • Global Assessment of Disease Activity visual analog scale (VAS)greater than or equal to 20/100 mm • If on one or more conventional DMARDs at randomization, must have been on a stable dose for at least 8 weeks prior to study start. • Woman must not be pregnant, breastfeeding, or become pregnant during the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Use of unstable doses of non-steroidal inflammatory drugs (NSAIDS) in the past 6 weeks • Steroid injection or intravenous (iv) infusion in the last 6 weeks • Use of more than 10 mg/day of oral steroids in the last 6 weeks • Use of biologic DMARD concurrently or recently • History of a serious reaction to other biological DMARDs • Use of an oral calcineurin inhibitor (e.g., cyclosporin or tacrolimus) in the last 8 weeks • Surgery on a joint or other major surgery less than 2 months ago, or plans to have joint surgery or major surgery during the study • Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA • Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years • Received a live vaccine received within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines) • Hepatitis or human immunodeficiency virus (HIV) • A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months • Symptoms of herpes zoster or herpes simplex within the last month • Active or latent tuberculosis (TB) • Current symptoms of a serious disorder or illness • Use of an investigational drug within the last month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate, in patients with RA who have at least 5/68 tender and at least 5/66 swollen joints at baseline, the superiority of 120 mg LY2127399 every four weeks (Q4W) (LY A) or 90 mg LY2127399 every two weeks (Q2W) (LY B), each after a loading dose, compared to placebo as measured by the American College of Rheumatology 20% response rates (ACR20) over 24 weeks.;Secondary Objective: • To demonstrate, in patients with RA who have at least 5/68 tender and at least 5/66 swollen joints at baseline, the superiority of LY A or LY B compared to placebo over 24 weeks, as assessed by the: ? ACR 50% response rate (ACR50), ACR 70% response rates (ACR70), and ACR percent improvement (ACR-N) indices ? Individual components of the ACR Core Set ? Disease Activity Score based on a 28 joint count (DAS28) and C-reactive protein level (CRP) (DAS28-CRP) ? European League Against Rheumatism Responder Index based on the 28 joint count (EULAR-28) ? Health outcome measures: Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) ? Time to ACR20 response • To demonstrate, in patients with RA who have at least 5/68 tender and at least 5/66 swollen joints at baseline, the superiority of LY A or LY B compared to placebo over 24 weeks for subpopulations defined by concomitant DMARD as assessed by the: ? ACR20 and ACR50 indices ? DAS28-CRP;Primary end point(s): • Percentage of patients with American College of Rheumatology 20% response (ACR20) • Percentage of patients with American College of Rheumatology 50% (ACR50) and 70% (ACR70) response • Mean percent improvement in ACR-N • Change from baseline to 24 weeks in Tender Joint Count (68 joint count) • Change from baseline to 24 weeks in Swollen Joint Count (66 joint count) • Change from baseline to 24 weeks in Patient's Assessment of Pain (VAS) • Change from baseline to 24 weeks in Patient's Global Assessment of Disease Activity (VAS) • Change from baseline to 24 weeks in P | — |
Countries
Bulgaria, Hungary, Lithuania, Poland
Outcome results
None listed