A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 81

Inclusion Criteria

- Male and female patients
- Age >= 18 years old
- BMI: < 30 and > 18
- Diagnosis of RA according to 2010 ACR/EULAR criteria and with a disease duration of at least 6 months since diagnosis
- Patient must present with active RA, characterized by at least 6 swollen joints out of 66 assessed and 6 tender jointsout of 68 assessed and by the presence of synovitis (measured by ultrasound) in at least one of the 6 swollen joints
- C-reactive protein (CRP) level > 0.7 mg/dL or if the CRP level is between 0.3 mg/dL and 0.7 mg/dL (included) then patient must also present an ESR > 30mm/hr
- Patients must have received MTX treatment for at least 3 months and have been on a stable dose of MTX for at least 6 weeks prior to start of screening
- ACPA-positive RA patients
- Women must be postmenopausal (> 12 months without menses) or surgically sterile or if considered of child bearing potential must be using at least a highly effective contraception method for at least for 4 weeks prior to the randomization date and agree to continue contraception for the duration of their participation in the study (until the end of follow up period).
- Sexually active male patients must use a barrier method of contraception during the course of the study (and until the end of the follow up period), in addition to their partner(s) using another highly effective method
- Patients must give written informed consent for study participation
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 41
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

- A documented history of an autoimmune disease other than RA by ACR classification, or Sjögren syndrome
- Administration of cytotoxic drugs and immune suppressants (other than MTX) within 3 months prior to screening
- Previous multiple administrations of any biological DMARD or targeted synthetic DMARD
- Known primary immunodeficiency
- Pregnant or breastfeeding women
- Suspicion of active or latent tuberculosis
- HIV, HCV, HBV infection
- Infection reported during screening not recovered 72h prior to first dose
- History of anaphylactic reactions to any protein therapeutics or excipients
- Any history of malignancy, excluding cured basal or squamous cell carcinoma of the skin, or cervical in situ carcinoma
- Clinically significant cardiac disease requiring medication, such as congestive heart failure, unstable angina, myocardial infarction within 6 months prior to randomization
- Moderate to severe renal insufficiency, clinically relevant liver function test abnormalities or pancytopenia
- Major psychiatric or neurological disorder
- Administration of anti-RANKL monoclonal antibody within 3 months
prior to screening.

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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