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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34310

Enrollment

Registered

2010-04-09

Start date

2010-06-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatoïde arthritis chronic inflammatory rheumatism

Interventions

Study Medication Active substance: MORAb-022 Activity: human monoclonal antibody targeting GM-CSF Indication: rheumatoid arthritis (RA) Strength: unknown Dosage form: iv infusion Treatments Healthy

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)