Clinical trial NCT01357759: Safety and Tolerability of MORAb-022 in Healthy and Rheumatoid Arthritis Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Trial of MORAb-022 in Healthy Subjects and Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Morphotek
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Approximately 113 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Jacksonville
country: United States
facility: Seaview Jacksonville, LLC
state: Florida
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Zuidlaren
country: Netherlands
facility: Pharmaceutical Research Associates Group B.V.
Study officials:
affiliation: Altoona Center for Clinical Research
name: Alan J. Kivitz, MD, CPI
role: PRINCIPAL_INVESTIGATOR
affiliation: Axis Clinical Trials
name: Lydie Hazan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seaview Jacksonville, LLC
name: Chrysoula Pappa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lynn Health Science Institute
name: William M Schnitz, MD
role: PRINCIPAL_INVESTIGATOR
References: