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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01559103
First received: March 19, 2012
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
Biological: MEDI5117
Biological: MEDI5117 Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: May 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559103

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Germany
Research Site
Berlin, Germany
United Kingdom
Research Site
Belfast, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Joel Posner, MD Astrazeneca, Waltham, MA, United States
Principal Investigator: David J Bell, MD Biokinetics, North Irland
Study Director: Joel Posner, MD Waltham, MA, USA
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01559103     History of Changes
Other Study ID Numbers: D4430C00001
Study First Received: March 19, 2012
Last Updated: August 11, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
Rheumatoid Arthritis
Phase I
Biologic

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014