A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects

Completed · Phase 4

Conditions studied: Rheumatoid Arthritis

In brief

Phase 4 study to evaluate a routine patient completed assessment (RAPID3) compared to a physician completed assessment (CDAI) to predict treatment success with subjects with moderate to severe rheumatoid arthritis

Key facts

Study ID

NCT01255761

Run by

UCB Pharma

People needed

736

Starts

2010-11-01

Expected to finish

2012-12-01

Last updated by the study team

2018-07-31

Who can join

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

You may qualify if…

• Subjects 18 years of age or older
• Subjects with a diagnosis of Adult-onset Rheumatoid Arthritis of at least 3 months as defined by the 1987 American College of Rheumatology (ACR) classification criteria
• Subjects with active Rheumatoid Arthritis as defined by:
• 4 tender joints (28 joint count) at Screening and Baseline Visits; and
• 4 swollen joints (28 joint count) at Screening and Baseline Visits
• Subjects who have had an unsatisfactory response or intolerance to at least 1 traditional Disease-modifying Antirheumatic Drugs (DMARD)

You may not qualify if…

• Subjects must not have a diagnosis of any other inflammatory Arthritis
• Subjects must not have greater than 3 Arthroplasties due to Rheumatoid Arthritis and/or Steinbrocker IV Functional Capacity
• Subjects must not have a secondary non-inflammatory type of Arthritis that would interfere with study evaluation
• Subjects must not be diagnosed with Fibromyalgia with sufficient symptoms requiring treatment
• Subjects must not have a history of Infected Joint Prosthesis
• Subjects must not have discontinued biological therapy for their Rheumatoid Arthritis due to Severe Hypersensitivity Reaction or Anaphylactic Reaction
• Subjects must not have received more than 2 anti- Tumor Necrosis Factor (TNF) agents prior to enrollment
• Subjects must not have received treatment with Abatacept and/or Rituximab or have received any experimental or approved B cell therapeutic agent
• Subjects must not have a history of chronic alcohol or drug abuse
• Subjects must not have known hypersensitivity to any components of the investigational medicinal product
• Subjects must not have a history of chronic infections, recent serious or life-threatening infection within 6 months or any current sign or symptom that may indicate an infection
• Subjects must not have a history of a Blood Dyscrasias
• Subjects with known Tuberculosis (TB) Disease, high risk of acquiring TB or latent TB infection
• Subjects must not be at high risk of infection
• Subjects must not have a history of Lymphoproliferative Disorder including Lymphoma signs and symptoms suggestive of Lymphoproliferative Disease
• Subjects must not have concurrent acute or chronic Viral Hepatitis B or C
• Subjects must not have known Human Immunodeficiency Virus (HIV) infection
• Subject must not have concurrent Malignancy or history of Malignancy
• Subjects must not 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 Class III or IV Congestive Heart Failure
• Subjects must not have history of, or suspected Demyelinating Disease of the Central Nervous System
• Subjects must not have a history of adverse reaction to Polyethylene Glycol (PEG)
• Subjects must not have significant laboratory abnormalities which in the investigators judgment would make the subject unsuitable for inclusion
• Subjects must not have a known history or clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, Nontuberculous Mycobacteria, Blastomyces or Aspergillus
• Subject must not have a known history of or be currently diagnosed with Systemic Lupus Erythematosus

Where it is running

• 166 — Huntsville, Alabama, United States
• 165 — Peoria, Arizona, United States
• 216 — Tucson, Arizona, United States
• 168 — Hot Springs, Arkansas, United States
• 241 — Jonesboro, Arkansas, United States
• 153 — Little Rock, Arkansas, United States
• 111 — Covina, California, United States
• 208 — Escondido, California, United States
• 103 — Fullerton, California, United States
• 155 — Huntington Beach, California, United States
• 202 — La Mesa, California, United States
• 203 — Loma Linda, California, United States
• 233 — Los Angeles, California, United States
• 105 — Palm Desert, California, United States
• 229 — Roseville, California, United States
• 113 — Sacramento, California, United States
• 127 — San Diego, California, United States
• 106 — Santa Maria, California, United States
• 172 — Santa Monica, California, United States
• 212 — Upland, California, United States
• 231 — Van Nuys, California, United States
• 158 — Whittier, California, United States
• 121 — Bridgeport, Connecticut, United States
• 200 — Bridgeport, Connecticut, United States
• 137 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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