Clinical trial NCT01559103: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Phase I
Biologic
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-21
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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)

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.

Primary outcomes:
measure: Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables.
timeFrame: From Baseline up to 64 weeks
Secondary outcomes:
measure: Description of pharmacokinetics in terms of Maximum serum concentration (Cmax), time to Cmax (tmax), terminal rate constant(λz), terminal half-life (t1/2 λz).
timeFrame: 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.
measure: 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).
timeFrame: 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.
measure: 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)].
timeFrame: 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.
measure: Descriptions of pharmacokinetics in terms of systemic clearance (CL), volume of distribution during terminal phase (Vz), and volume of distribution at steady state (Vdss).
timeFrame: 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.
measure: 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.
timeFrame: From Baseline day -1 to week 64
measure: Description of immunogenicity in terms of positive or negative for the presence of antidrug antibodies against MEDI5117 in blood.
timeFrame: From Baseline day -1 to week 64
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Belfast
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References: