Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients - Full Text View

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:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

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 ]

Estimated Enrollment:	40
Study Start Date:	May 2012
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (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

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:	January 25, 2013
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 June 18, 2013