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

Novo Nordisk

Status and phase

Terminated

Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Biological: MEDI5117

Biological: MEDI5117 Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01559103

2011-005402-29 (Registry Identifier)

NN6018-4789

Details and patient eligibility

About

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

Full 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)

Enrollment

39 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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.