A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Certolizumab Pegol (CZP)
Intervention description: 400 mg subcutaneous injection at Weeks 0, 2 and 4
200 mg subcutaneous injection every two weeks, Week 6 through Week 52
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 736.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Certolizumab Pegol; Cimzia; Rheumatoid Arthritis; CDAI; RAPID3

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
    

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