Clinical trial NCT01292265: A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA)
Official title: A Phase 3b, Open Label, Multicenter, Exploratory Study to Assess Changes in Joint Inflammation Using Ultrasonography in Subjects With Rheumatoid Arthritis Treated for 12 Weeks With Certolizumab Pegol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Arthritis
Joint pain
Inflammation
Rheumatoid Arthritis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-02-09
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12
timeFrame: From Baseline (Week 0) to Week 12
Secondary outcomes:
measure: Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12
timeFrame: From Baseline (Week 0) to Week 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: 10
state: California
city: Walnut Creek
country: United States
facility: 4
state: California
city: Wheaton
country: United States
facility: 8
state: Maryland
city: Voorhees
country: United States
facility: 1
state: New Jersey
city: Rochester
country: United States
facility: 6
state: New York
city: Franklin
country: United States
facility: 7
state: Wisconsin
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: