BI695501 compared to adalimumab in patients with active rheumatoid arthritis

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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