Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients
Primary Purpose
Rheumatoid Arthritis
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MEDI5117
MEDI5117 Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Phase I, Biologic
Eligibility Criteria
Inclusion Criteria:
- Active Rheumatoid Arthritis (RA) for 6 months or more.
- Males or nonpregnant, nonlactating femails aged 20 to 75 years, inclusive.
- Body Mass Index (BMI) between 19 and 36 kg/m2 and weight between 50 and 145 kg, inclusive.
- Males, unless surgically sterile, must use 2 effective methods of birth control from Day 1 through follow-up.
Exclusion Criteria:
- History or presence of any clinically significant disease or disorder which has not been stable over the previous 3 months.
- History of liver disease, bilirubin elevations, or Gilbert's Syndrome.
- Any systematic inflammatory condition in addition to RA (polymyalgia rheumatica, giant cell arthritis, systemic lupus, gout, pyrophosphate arthropathy).
- Current, chronic pain disorders including fibromyalgia and chronic regional pain syndromes or chronic fatigue syndromes.
- Intramuscular steroid injection or intraarticular steroid injection within 1 month of enrollment.
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MEDI5117
MEDI5117 Placebo
Arm Description
Intravenous infusion administered over 60 minutes
Intravenous infusion administered over 60 minutes
Outcomes
Primary Outcome Measures
Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables.
Secondary Outcome Measures
Description of pharmacokinetics in terms of Maximum serum concentration (Cmax), time to Cmax (tmax), terminal rate constant(λz), terminal half-life (t1/2 λz).
Description of pharmacokinetics in terms of area under the serum concentration-time curve from zero to the time of the last quantifiable concentration [AUC(0-t)] and from zero to infinity (AUC).
Description of pharmacokinetics in terms of area under the serum concentration-time curve from zero to the time of concentration at Weeks 6 and 12 [AUC(0-6w) and AUC(0 12w)].
Descriptions of pharmacokinetics in terms of systemic clearance (CL), volume of distribution during terminal phase (Vz), and volume of distribution at steady state (Vdss).
Description of pharmacodynamics in terms of total interleukin 6 (IL-6) and free IL-6 (exploratory) in plasma and high sensitive C-reactive protein (hs-CRP) pre and post MEDI5117 or placebo administration and their corresponding change from baseline.
Description of immunogenicity in terms of positive or negative for the presence of antidrug antibodies against MEDI5117 in blood.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01559103
Brief Title
Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients
Official Title
A Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI5117 (Anti-IL-6)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Study Start Date
May 31, 2012 (Actual)
Primary Completion Date
February 28, 2014 (Actual)
Study Completion Date
February 28, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
5. Study Description
Brief Summary
Study to assess the safety and tolerability of MEDI5117 in Rheumatoid Arthritis patients
Detailed Description
A Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI5117 (anti-IL-6)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Phase I, Biologic
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDI5117
Arm Type
Experimental
Arm Description
Intravenous infusion administered over 60 minutes
Arm Title
MEDI5117 Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous infusion administered over 60 minutes
Intervention Type
Biological
Intervention Name(s)
MEDI5117
Intervention Description
Intravenous infusion administered over 60 minutes, will be one of the following doses: 30, 100, 300, or 600 mg
Intervention Type
Biological
Intervention Name(s)
MEDI5117 Placebo
Intervention Description
Intravenous infusion administered over 60 minutes
Primary Outcome Measure Information:
Title
Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables.
Time Frame
From Baseline up to 64 weeks
Secondary Outcome Measure Information:
Title
Description of pharmacokinetics in terms of Maximum serum concentration (Cmax), time to Cmax (tmax), terminal rate constant(λz), terminal half-life (t1/2 λz).
Time Frame
From Day 1 Predose, 2h, 12h, 24h, day 7, week 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 56 and week 64.
Title
Description of pharmacokinetics in terms of area under the serum concentration-time curve from zero to the time of the last quantifiable concentration [AUC(0-t)] and from zero to infinity (AUC).
Time Frame
From Day 1 Predose, 2h, 12h, 24h, day 7, week 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 56 and week 64.
Title
Description of pharmacokinetics in terms of area under the serum concentration-time curve from zero to the time of concentration at Weeks 6 and 12 [AUC(0-6w) and AUC(0 12w)].
Time Frame
From Day 1 Predose, 2h, 12h, 24h, day 7, week 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 56 and week 64.
Title
Descriptions of pharmacokinetics in terms of systemic clearance (CL), volume of distribution during terminal phase (Vz), and volume of distribution at steady state (Vdss).
Time Frame
From Day 1 Predose, 2h, 12h, 24h, day 7, week 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 56 and week 64.
Title
Description of pharmacodynamics in terms of total interleukin 6 (IL-6) and free IL-6 (exploratory) in plasma and high sensitive C-reactive protein (hs-CRP) pre and post MEDI5117 or placebo administration and their corresponding change from baseline.
Time Frame
From Baseline day -1 to week 64
Title
Description of immunogenicity in terms of positive or negative for the presence of antidrug antibodies against MEDI5117 in blood.
Time Frame
From Baseline day -1 to week 64
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Active Rheumatoid Arthritis (RA) for 6 months or more.
Males or nonpregnant, nonlactating femails aged 20 to 75 years, inclusive.
Body Mass Index (BMI) between 19 and 36 kg/m2 and weight between 50 and 145 kg, inclusive.
Males, unless surgically sterile, must use 2 effective methods of birth control from Day 1 through follow-up.
Exclusion Criteria:
History or presence of any clinically significant disease or disorder which has not been stable over the previous 3 months.
History of liver disease, bilirubin elevations, or Gilbert's Syndrome.
Any systematic inflammatory condition in addition to RA (polymyalgia rheumatica, giant cell arthritis, systemic lupus, gout, pyrophosphate arthropathy).
Current, chronic pain disorders including fibromyalgia and chronic regional pain syndromes or chronic fatigue syndromes.
Intramuscular steroid injection or intraarticular steroid injection within 1 month of enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Berlin
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Belfast
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com
Learn more about this trial
Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients
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