Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Phase I, Biologic
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)
Interventions
BIOLOGICALMEDI5117
Intravenous infusion administered over 60 minutes, will be one of the following doses: 30, 100, 300, or 600 mg
BIOLOGICALMEDI5117 Placebo
Intravenous infusion administered over 60 minutes
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables. | From Baseline up to 64 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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). | 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. |
| 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)]. | 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. |
| Description of pharmacokinetics in terms of Maximum serum concentration (Cmax), time to Cmax (tmax), terminal rate constant(λz), terminal half-life (t1/2 λz). | 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. |
| 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. | From Baseline day -1 to week 64 |
| Description of immunogenicity in terms of positive or negative for the presence of antidrug antibodies against MEDI5117 in blood. | From Baseline day -1 to week 64 |
| Descriptions of pharmacokinetics in terms of systemic clearance (CL), volume of distribution during terminal phase (Vz), and volume of distribution at steady state (Vdss). | 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. |
Countries
Germany, United Kingdom, United States
Outcome results
None listed