Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients

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 to assess the safety and tolerability of MEDI5117 in Rheumatoid Arthritis patients

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: MEDI5117; Biological: MEDI5117 Placebo

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)

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Novo Nordisk Investigational Site
• United Kingdom
  • Belfast, United Kingdom
    • Novo Nordisk Investigational Site
• United States
  • Kansas
    • Overland Park, Kansas, United States
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MEDI5117; Intravenous infusion administered over 60 minutes	Biological: MEDI5117; Intravenous infusion administered over 60 minutes, will be one of the following doses: 30, 100, 300, or 600 mg
Placebo Comparator: MEDI5117 Placebo; Intravenous infusion administered over 60 minutes	Biological: MEDI5117 Placebo; Intravenous infusion administered over 60 minutes

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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 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.
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.
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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2012
• Primary Completion (Actual): February 28, 2014
• Study Completion (Actual): February 28, 2014

Study Registration Dates

• First Submitted: March 19, 2012
• First Submitted That Met QC Criteria: March 20, 2012
• First Posted (Estimate): March 21, 2012

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; Phase I; Biologic
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: NN6018-4789; 2011-005402-29 (Registry Identifier: European Medicines Agency (EudraCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com