A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate(FLEX-M)

• Conditions: Rheumatoid Arthritis; MedDRA version: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2010-022205-17-LT
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-28
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 990

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 886
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 104

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
• History of the use of rituximab, any other B cell targeted biotherapy, or denosumab

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified