a comparison of two assessment tools in predicting treatment success of cimzia in rheumatoid arthritis subjects

Conditions: Rheumatoid Arthritis

Summary: 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

ra0064 is a phase 4, multicenter, randomized, 52-week study. all eligible subjects will receive open label cimzia 400 mg at weeks 0, 2 and 4, followed by cimzia 200 mg every 2 weeks at weeks 6 to 50 for the treatment of moderate to severe rheumatoid arthritis. all subjects will be assessed using the 2 assessment tools: the subject-based routine assessment of patient index (rapid3) and the investigator-based clinical disease activity index (cdai)

Eligibility criteria:
inclusion criteria: * 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) exclusion criteria: * 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

Keywords: certolizumab pegol cimzia rheumatoid arthritis cdai rapid3