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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-02-28

Brief Summary

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

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Detailed Description

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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)

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MEDI5117

Intravenous infusion administered over 60 minutes

Group Type EXPERIMENTAL

MEDI5117

Intervention Type BIOLOGICAL

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

Group Type PLACEBO_COMPARATOR

MEDI5117 Placebo

Intervention Type BIOLOGICAL

Intravenous infusion administered over 60 minutes

Interventions

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MEDI5117

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

Intervention Type BIOLOGICAL

MEDI5117 Placebo

Intravenous infusion administered over 60 minutes

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No