Rheumatoid Arthritis
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study in healthy male and or female subjects and subjects with Rheumatoid Arthritis (RA) to determine the safety and tolerability of MORAb-022.
Interventions
DRUGMORAb-022
IV infusion of MORAb-022 at increasing doses starting with the minimal anticipated biological effect level (MABEL) which is 0.0085mg/kg.; IV infusion of Placebo (saline)
Sponsors
Morphotek
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
for Rheumatoid Arthritis (RA) Subjects: * Male or female subjects age greater than or equal to 18 years and less than or equal to 75 years. * Subjects with RA diagnosis per the 2010 Rheumatoid Arthritis Classification Criteria per American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR.) * BMI less than or equal to 35 kg/m2 at Screening. * Active RA characterized by DAS28 score of less than or equal to 5.1 at Screening. * Have been stabilized on their current dose (up to 25 mg/week) of methotrexate(MTX) for at least 4 weeks before randomization.
Exclusion criteria
for Rheumatoid Arthritis (RA)Subjects: * Subjects with severe active RA and are not on a stable therapeutic regimen at Screening. * Subjects without significant articular RA. * Relevant history of significant respiratory disease (e.g., chronic bronchitis, asthma in last 5 years, chronic obstructive pulmonary disease, tuberculosis, interstitial lung disease, such as pneumonitis and pulmonary alveolar proteinosis, as well as significant inhalation exposure to silicon and other substances) that required treatment and/or follow up under the direction of a physician. * Presence of GM-CSF autoantibodies above normal at Screening. * Abnormal chest x-ray or PFTs as judged by the investigator at Screening as clinically significant. * Positive Quantiferon test. * History of clinically relevant hypersensitivity reactions (e.g., to gold therapy) * History of medication use that might have carryover effects during the study. * Previous administration of a GM-CSF modulator within 6 months of randomization, or previous administration of a monoclonal antibody or immunoglobulin fusion protein that is not (or worded as other than) a GM-CSF modulator within 3 months of randomization. * Use of any biological therapy other than the test article during the study (informed consent to termination visit) * Subjects who consume greater than 14 alcoholic drinks per week for males or 7 alcoholic drinks per week for females. * Weight greater than 120 kg at Screening. * Use of parenteral and/or intra-articular steroids, immunosuppressants, investigational drugs, and oral anticoagulant drugs within 4 weeks prior to randomization. Oral steroid treatment is permitted if the dosage is less than or equal to 10 mg of prednisone daily, is stable for a minimum of 4 weeks before the study and remains unchanged throughout the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety to measures to include adverse events, clinical laboratory results, vital signs, ECGs, physical examinations, local tolerability at the infusion site single escalating intravenous (IV) doses of MORAb-022 in healthy subjects and subjects with RA. | Approximately 113 days |
Countries
Netherlands, United States
Outcome results
None listed