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

Phase 1

Terminated

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01559103
• Lead Sponsor: Novo Nordisk A/S

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)

Study Timeline

• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-21
• Study Start: 2012-05-31
• Primary Completion: 2014-02-28
• Study Completion: 2014-02-28
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Belfast, United Kingdom