BI695501 compared to adalimumab in patients with active rheumatoid arthritis

Phase 1

Conditions: Rheumatoid arthritis
MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2012-002945-40-BG

Lead Sponsor: Boehringer Ingelheim International GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 650

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: <0.4 mg/dL) at Screening. Patients must currently be receiving MTX therapy.
2. Current treatment for RA on an outpatient basis
3. For participants of reproductive potential (males and females), a reliable means of contraception has to be used throughout trial participation and for 6 months following completion or discontinuation from the trial.
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 430
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 220

Exclusion Criteria

1)ACR functional Class IV or wheelchair/bed bound
2)Primary or secondary immunodeficiency (history of, or currently active)
3)History of TB, latent TB, or positive purified protein derivative (PPD)
test or interferon gamma-releasing assay (IGRA)
4)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.
5)Previous treatment with adalimumab or adalimumab biosimilar.
6)Current treatment or previous treatment with leflunomide within 8
weeks (56 days) prior to Day 1.
7)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
8)History of cancer
9)Evidence of positive serology for HBV or HCV.
10)Platelets <100,000/µL; Leukocyte count <4000/µL; Creatinine
clearance <60 mL/min
11)Receipt of a live/attenuated vaccine within 12 weeks prior to Screening Visit.
12)Patients with a significant disease other than RA and/or a significant uncontrolled disease
13)History of, or current, inflammatory joint disease other than RA
14)Diagnosis of juvenile idiopathic arthritis, also known as juvenile RA, and/or RA before age 16
15)Known active infection
16)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.
17)Patients who have previously been randomized in this trial

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this trial is to establish an equivalence in<br>efficacy between BI 695501 and US-licensed Humira® in patients with<br>active RA based on a<br>statistical comparison of the proportion of patients meeting ACR20<br>response rate at Week 12 and ACR 20 response rate at Week 24 between<br>BI 695501 and US-licensed Humira®.;Secondary Objective: The secondary objectives of this trial are to compare the efficacy, safety<br>and immunogenicity of BI 695501 and US-licensed Humira® in patients<br>with active RA, including those undergoing the transition from US-licensed<br>Humira® to BI 695501 after 24<br>weeks.;Primary end point(s): Endpoint 1.The proportion of patients meeting the ACR20 ( American<br>College of Rheumatology 20%) response<br>criteria at Week 12<br>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<br>Endpoint 2. Week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Endpoint 1: The change from Baseline in DAS28 (ESR) at Week 12 and at<br>Week 24<br>Endpoint 2: The safety endpoint is defined as the proportion of patients<br>with drug-related AEs during the treatment phase;Timepoint(s) of evaluation of this end point: Endpoint 1: Week 12 and Week 24<br>Endpoint 2: Week 58