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

Phase 3

Terminated

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

Detailed Description: Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented. Only Adverse Event (AE) data will be summarized in a table, with frequency counts and percentages.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
CZP 200 mg	Certolizumab Pegol	Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.

Primary Outcome Measures

Name	Time	Method
Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12	From Baseline (Week 0) to Week 12

Secondary Outcome Measures

Name	Time	Method
Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12	From Baseline (Week 0) to Week 12
Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12	From Baseline (Week 0) to Week 12
Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12	From Baseline (Week 0) to Week 12

Locations (6): 1
🇺🇸
Voorhees, New Jersey, United States
10
🇺🇸
Los Angeles, California, United States
4
🇺🇸
Walnut Creek, California, United States
8
🇺🇸
Wheaton, Maryland, United States
6
🇺🇸
Rochester, New York, United States
7
🇺🇸
Franklin, Wisconsin, United States