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: • Male and female patients 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 • Regular use of methotrexate (MTX) in the past 12 weeks, with the dose being stable during the past 8 weeks • At least 8 tender and swollen joints • At least one erosion of a hand or foot joint observed on an X-ray • An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR) • Positive for Rheumatoid Factor (RF) or Anti-cyclic citrullinated peptide (CCP) antibody • 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 • History of an inadequate response to a biologic disease-modifying anti-rheumatic drug (DMARD) • History of a serious reaction to other biological DMARDs • History of the use of rituximab or other B cell therapy • Use of DMARDS other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks • Use of leflunomide within the last 12 weeks (unless cholestyramine was used to speed up the elimination of leflunomide) • 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 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 objectives of this study are to demonstrate, in patients on background MTX therapy, the superiority of 120 mg LY2127399 every 4 weeks (Q4W) (LY A) or 90 mg LY2127399 every 2 weeks (Q2W) (LY B), each after a loading dose, compared to placebo as follows: ? American College of Rheumatology 20% response rates (ACR20) at Week 24 ? Structural progression as measured by van der Heijde modified Total Sharp Score (mTSS) at Week 52 ? Health Assessment Questionnaire-Disability Index (HAQ-DI) scores at Week 24. ;Secondary Objective: The secondary objectives of the study are as follows: • To demonstrate, in patients on background MTX therapy, the superiority of LY A or LY B compared to placebo over 52 weeks • To evaluate structure (X-rays) • To evaluate the safety and tolerability of LY A or LY B compared to placebo. • To characterize the time course of change in absolute B cell counts, B cell subsets, and changes in serum Ig levels to treatment with LY2127399 versus placebo over 52 weeks. • To characterize the population PK of LY2127399 and explore PK/ PD relationships with efficacy, safety and biomarker endpoints. • To assess the potential development of anti LY2127399 antibodies and the impact on patient safety, efficacy, and PK of LY2127399. Additional exploratory measures will be studied, including: • To explore biomarkers that may be contained in serum, plasma, messenger ribonucleic acid (mRNA), and deoxyribonucleic acid (DNA) samples.;Primary end point(s): • Percentage of patients with American College of Rheumatology 20% response (ACR20) at Week 24 • Change from baseline to Week 52 in van der Heijde modified Total Sharp Score (mTSS) • Change from baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) • Percentage of patients with American College of Rheumatology 50% (ACR50) and 70% (ACR70) response • Change from baseline in Disease Activity Score C-Reactive Protein (DAS28-CRP) • Percentage of patients with DAS | — |
Countries
Bulgaria, Hungary, Lithuania, Poland
Outcome results
None listed