BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis

Inclusion criteria

• All patients must sign and date an Informed Consent Form consistent with International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines and local legislation prior to participation in the trial (i.e. prior to any trial procedures, which include medication washout and restrictions) and be willing to follow the protocol.
• Male or female participants, between 18 and 80 years of age, who have a diagnosis of moderately to severely active Rheumatoid arthritis for at least 6 months as defined by at least six swollen joints (66 joint count) and at least six tender joints (68 joint count) at Screening and Baseline (Day 1), and either an Erythrocyte sedimentation rate of >28 mm/hour OR a C-reactive protein (CRP) level >1.0 mg/dL (normal: =2 biologic agents.
• Previous treatment with adalimumab or adalimumab biosimilar.
• Current treatment or previous treatment with leflunomide within 8 weeks.
• History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to adalimumab or any component of the trial drug.
• History of cancer including solid tumors, hematologic malignancies, and carcinoma in situ.
• Has evidence of positive serology for Hepatitis B virus or Hepatitis C virus
• Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit. Patients who are expecting to receive any live virus or bacterial vaccinations during the trial, or up to 3 months after the last dose of trial drug.
• Any treatment that, in the opinion of the investigator, may place the patient at unacceptable risk during the trial.
• Patients with a significant disease other than Rheumatoid arthritis and/or a significant uncontrolled disease (such as, but not limited to, nervous system, renal, hepatic, endocrine, or gastrointestinal disorders). A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial.
• Premenopausal, sexually active women who are pregnant or nursing, or are of child-bearing potential and not practicing an acceptable method of birth control, or do not plan to continue practicing an acceptable method of birth control throughout the trial.
• History of, or current, inflammatory joint disease other than Rheumatoid arthritis or other systemic autoimmune disorder.
• Diagnosis of juvenile idiopathic arthritis, and/or Rheumatoid arthritis before age 16.
• Any planned surgical procedure within 12 weeks prior to the Screening Visit or for the duration of the trial.
• Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with intravenous anti infectives within 4 weeks of the Screening Visit or completion of oral anti-infectives within 2 weeks of the Screening Visit.
• History of deep space/tissue infection within 52 weeks of the Screening Visit.
• History of serious infection or opportunistic infection in the last 2 years.
• Any neurological, vascular or systemic disorder that might affect any of the efficacy assessments.
• Currently active alcohol or drug abuse or history of alcohol or drug abuse within 2 years of the Screening Visit.
• Treatment with intravenous Gamma Globulin or the Prosorba® Column within 6 months of the Screening Visit.
• Treatment with intravenous, intramuscular, intra-articular and parenteral corticosteroids within 6 weeks prior to Day 1 or throughout the trial.
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times upper limit of normal.
• Hemoglobin <8.0 g/dL.
• Platelets <100,000/µL.
• Leukocyte count <4000/µL.
• Creatinine clearance <60 mL/min.
• Patients who are currently participating in another clinical trial or who have been participating in another clinical trial