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

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ClinicalTrials.gov Identifier: NCT01559103
Recruitment Status : Terminated
First Posted : March 21, 2012
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
Study to assess the safety and tolerability of MEDI5117 in Rheumatoid Arthritis patients

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: MEDI5117 Biological: MEDI5117 Placebo Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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)
Actual Study Start Date : May 31, 2012
Actual Primary Completion Date : February 28, 2014
Actual Study Completion Date : February 28, 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables. [ Time Frame: From Baseline up to 64 weeks ]

Secondary Outcome Measures :
  1. Description of pharmacokinetics in terms of Maximum serum concentration (Cmax), time to Cmax (tmax), terminal rate constant(λz), terminal half-life (t1/2 λz). [ Time Frame: 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. ]
  2. 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). [ Time Frame: 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. ]
  3. 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)]. [ Time Frame: 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. ]
  4. Descriptions of pharmacokinetics in terms of systemic clearance (CL), volume of distribution during terminal phase (Vz), and volume of distribution at steady state (Vdss). [ Time Frame: 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. ]
  5. 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. [ Time Frame: From Baseline day -1 to week 64 ]
  6. Description of immunogenicity in terms of positive or negative for the presence of antidrug antibodies against MEDI5117 in blood. [ Time Frame: From Baseline day -1 to week 64 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559103


Locations
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United States, Kansas
Novo Nordisk Investigational Site
Overland Park, Kansas, United States
Germany
Novo Nordisk Investigational Site
Berlin, Germany
United Kingdom
Novo Nordisk Investigational Site
Belfast, United Kingdom
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (dept. 1452) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01559103    
Other Study ID Numbers: NN6018-4789
2011-005402-29 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: March 21, 2012    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com
Keywords provided by Novo Nordisk A/S:
Rheumatoid Arthritis
Phase I
Biologic
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases