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

UCB

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Biological: Certolizumab Pegol (CZP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01255761

RA0064

Details and patient eligibility

About

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

Full description

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)

Enrollment: 736 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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736 participants in 2 patient groups

RAPID3 to assess response to Cimzia

Other group

Description:

RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points

Treatment:

Biological: Certolizumab Pegol (CZP)

CDAI to assess response to Cimzia

Other group

Description:

CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)

Treatment:

Biological: Certolizumab Pegol (CZP)