BI695501 compared to adalimumab in patients with active rheumatoid arthritis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

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 5 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 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1)ACR functional Class IV or wheelchair/bed bound
2)Primary or secondary immunodeficiency (history of, or currently
active)
3)Positive TB test without treatment for TB infection or
chemoprophylaxis for TB exposure.
4)Known clinically significant coronary artery disease or significant
cardiac arrhythmias or severe congestive heart failure
5)Previous treatment with any biologic agent
6)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
7)History of cancer
8)Positive serological test for hepatitis B or for hepatitis C
9)Receipt of a live/attenuated vaccine within 12 weeks prior to
Screening Visit.
10)Patients with a significant disease other than RA and/or a significant
uncontrolled disease
11)History of, or current, inflammatory joint disease other than RA
12)Diagnosis of juvenile idiopathic arthritis, also known as juvenile RA,
and/or RA before age 16
13)Known active infection
14)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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