Rheumatoid arthritis MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Code: BI 695501
Pharmaceutical Form: Solution for injection
INN or Proposed INN: -
CAS Number: -
Current Sponsor code: BI 695501
Other descriptive name: BI 695501
Concentration unit: mg/ml mil
Sponsors
Boehringer Ingelheim International GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female participants, between 18 and 80 years of age, who have a diagnosis of moderately to severely active RA 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 ESR of >28 mm/hour OR a CRP level >1.0 mg/dL (normal: =65 years) yes F.1.3.1 Number of subjects for this age range 220
Exclusion criteria
Exclusion criteria: •ACR functional Class IV or wheelchair/bed bound •Primary or secondary immunodeficiency (history of, or currently active) •History of TB, latent TB, or positive purified protein derivative (PPD) test or interferon gamma-releasing assay (IGRA) •Previous treatment with =2 biologic agents. Patients who have received prior treatment with 1 biologic agent >4 months prior to screening may participate in the trial. •Previous treatment with adalimumab or adalimumab biosimilar. •Current treatment or previous treatment with leflunomide within 8 weeks (56 days) prior to Day 1. •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 •Evidence of positive serology for HBV or HCV. •Platelets <100,000/µL; Leukocyte count <4000/µL; Creatinine clearance <60 mL/min. •Receipt of a live/attenuated vaccine within 12 weeks prior to Screening Visit. •Patients with a significant disease other than RA and/or a significant uncontrolled disease •History of, or current, inflammatory joint disease other than RA •Diagnosis of juvenile idiopathic arthritis, also known as juvenile RA, and/or RA before age 16 •Known active infection •Patients who are currently participating in another clinical trial or who have been participating in another clinical trial with another investigational drug within a minimum of 12 weeks or five half-lives (whichever is longer) of the drug prior to Day 1. •Patients who have previously been randomized in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to establish an equivalence in efficacy between BI 695501 and US-licensed Humira® in patients with active RA based on a statistical comparison of the proportion of patients meeting ACR20 response rate at Week 12 and ACR 20 response rate at Week 24 between BI 695501 and US-licensed Humira®.;Secondary Objective: The secondary objectives of this trial are to compare the efficacy, safety and immunogenicity of BI 695501 and US-licensed Humira® in patients with active RA, including those undergoing the transition from US-licensed Humira® to BI 695501 after 24 weeks.;Primary end point(s): Endpoint 1.The proportion of patients meeting the ACR20 (American College of Rheumatology 20%) response criteria at Week 12 Endpoint 2.The proportion of patients meeting the ACR20 response criteria at Week 24;Timepoint(s) of evaluation of this end point: Endpoint 1. Week 12 Endpoint 2. Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Endpoint 1: The change from Baseline in DAS28 (ESR) at Week 12 and at Week 24 Endpoint 2: The safety endpoint is defined as the proportion of patients with drug-related AEs during the treatment phase;Timepoint(s) of evaluation of this end point: Endpoint 1: Week 12 and Week 24 Endpoint 2: Week 58 | — |
Countries
Bulgaria, Chile, Estonia, Germany, Hungary, Korea, Republic of, Malaysia, New Zealand, Poland, Russian Federation, Serbia, South Africa, Spain, Thailand, Ukraine, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed