BI695501 compared to adalimumab in patients with active rheumatoid arthritis

• Register: EUCTR
• Last refreshed on: 31 October 2016
• Main ID: EUCTR2012-002945-40-EE
• Date of registration: 10/04/2014
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim International GmbH
• Public title: BI695501 compared to adalimumab in patients with active rheumatoid arthritis
• Scientific title: Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial
• Date of first enrolment: 09/05/2014
• Target sample size: 650
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002945-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Chile, Estonia, Germany, Hungary, Korea, Republic of, Malaysia, New Zealand, Poland, Russian Federation, Serbia, Spain, Thailand, Ukraine, United States

Contacts

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

Key inclusion & exclusion 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: <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:
•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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis
MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

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 milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Endpoint 1. Week 12
Endpoint 2. Week 24

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.

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.

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 Outcome(s)

Timepoint(s) of evaluation of this end point: Endpoint 1: Week 12 and Week 24
Endpoint 2: Week 58

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

Secondary ID(s)

1297.2

2012-002945-40-DE

Source(s) of Monetary Support

Boehringer Ingelheim International GmbH