Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Trial of MORAb-022 in Healthy Subjects and Subjects With Rheumatoid Arthritis
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Pharmaceutical Research Associates Group B.V. | Zuidlaren | |
United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
United States | Seaview Jacksonville, LLC | Jacksonville | Florida |
United States | Axis Clinical Trials | Los Angeles | California |
United States | Lynn Health Science Institute | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Morphotek |
United States, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
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