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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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

Key facts

Study ID

NCT01559103

Run by

Novo Nordisk A/S

People needed

39

Starts

2012-05-31

Expected to finish

2014-02-28

Last updated by the study team

2021-02-09

Who can join

Age: 20 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novo Nordisk Investigational Site — Overland Park, Kansas, United States
• Novo Nordisk Investigational Site — Berlin, Germany
• Novo Nordisk Investigational Site — Belfast, United Kingdom

Full record on ClinicalTrials.gov

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