A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA)

Stopped early · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

To evaluate the changes in joint inflammation produced by Cimzia over 12 week Treatment period measured by Power/Color Doppler and Gray scale Ultrasound.

Key facts

Study ID

NCT01292265

Run by

UCB Pharma

People needed

3

Starts

2011-02-01

Expected to finish

2012-01-01

Last updated by the study team

2018-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with adult-onset Rheumatoid Arthritis (RA) >6 months and <3 years
• Active RA
• Must have failed at least one disease modifying Anti Rheumatic Drug (DMARD) treatment
• Subject can have attempted no more than one previous Anti Tumor Necrosis factor (anti-TNF) and discontinued due to drug intolerance

You may not qualify if…

• Subject cannot have a second non-inflammatory musculoskeletal condition
• Subject cannot have a diagnosis of any other inflammatory arthritis
• Subject cannot have any previously infected prosthesis
• Subject cannot have arthroplasties in any of the joints assessed in the study
• Subject cannot have a history of chronic infections
• Subject cannot have known Tuberculosis (TB) disease, high risk of acquiring TB, or latent TB infection
• Subject cannot have a history of or current Lymphoproliferative disorder
• Subject cannot have known Human Immunodeficiency Virus (HIV) infection
• Subject cannot have received a live or attenuated vaccine within 8 weeks
• Subject cannot have current or history of malignancy
• Subject cannot have a history of blood disorders
• Subject cannot have a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
• Subjects must not have a history of adverse reaction to Polyethylene glycol (PEG), a protein medicinal product, or ultrasound gel applied to the skin

Where it is running

• 10 — Los Angeles, California, United States
• 4 — Walnut Creek, California, United States
• 8 — Wheaton, Maryland, United States
• 1 — Voorhees Township, New Jersey, United States
• 6 — Rochester, New York, United States
• 7 — Franklin, Wisconsin, United States

Full record on ClinicalTrials.gov

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