A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation STUDY of MORAb-022 in Healthy SUBJECTS and Subjects with Rheumatoid Arthritis.

Completed

Conditions: rheumatoïde arthritis
chronic inflammatory
rheumatism

Registration Number: NL-OMON34310

Lead Sponsor: Eisai

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Healthy subjects:
Healthy male and postmenopausal female subjects, age between 18 and 65 years, BMI between 18 and 30kg/m2, non-smoker.;Patients:
Male and female subjects with RA, age between 18 and 70 years, BMI is * 35 kg/m2, subjects must be on a stable dose of methotrexate (MTX) for >4 consecutive weeks in the period prior to randomization, at screening the duration of the active disease is of >3 months from the onset of persistent synovitis (i.e. inflammation of the joints), non-smoker or smoke occasionally.

Exclusion Criteria

Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood (for men)/ more than 1.0 liters of blood (for women) in the 10 months prior the start of this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacodynamics:<br /><br>Antibodies to MORAb-022, serum/plasma inflammatory markers IL-6, TNF-, IL-1,<br /><br>IFN- concentrations, CD11b receptor expression on neutrophils, circulating<br /><br>GM-CSF levels, shift in T-cell profiles, and DAS, ACRn and VAS scores.<br /><br><br /><br>Pharmacokinetics:<br /><br>Plasma MORAb-022 concentrations, pharmacokinetic parameters.<br /><br><br /><br>Safety:<br /><br>Adverse events, vital signs, ECG-parameters, laboratory parameters, physical<br /><br>examination, SP-D levels, PFT.</p><br>

Secondary Outcome Measures