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

Rheumatoid Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01559103
• Other study ID #: NN6018-4789
• Secondary ID: 2011-005402-29
• Status: Terminated
• Phase: Phase 1
• Start date: May 31, 2012
• Est. completion date: February 28, 2014

Study information

• Verified date: February 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: February 28, 2014
• Est. primary completion date: February 28, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• MEDI5117
Intravenous infusion administered over 60 minutes, will be one of the following doses: 30, 100, 300, or 600 mg
• MEDI5117 Placebo
Intravenous infusion administered over 60 minutes

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin
United Kingdom	Novo Nordisk Investigational Site	Belfast
United States	Novo Nordisk Investigational Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Description of pharmacokinetics in terms of Maximum serum concentration (Cmax), time to Cmax (tmax), terminal rate constant(?z), terminal half-life (t1/2 ?z).		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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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