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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Rheumatoid Arthritis
Unfortunately contact details are not available for this trial.
Primary Contact Details
Stopped
Recruitment Status
NCT01559103
Primary Trial ID Number
Summary
Study to assess the safety and tolerability of MEDI5117 in Rheumatoid Arthritis patients
Research Details
  • 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)
Phase
Phase 1
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Study Type
Interventional
Intervention
Biological : MEDI5117, Biological : MEDI5117 Placebo

Study Arm Groups : MEDI5117, MEDI5117 Placebo

Intervention Type
See Interventions above
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.; From Baseline up to 64 weeks
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).; 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
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
20 Years - 75 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Ulster Hospital
Belfast
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Germany, United Kingdom
Scientific 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)
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
D4430C00001
Sponsor(s)
AstraZeneca
Key Dates

Recruitment Start Date

May 2012

Recruitment End Date

Feb 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

19 Mar 2012

Last Updated

19 Feb 2015